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JADA manuscript ID: # 077-09  Updated January 1, 2012

Synopis of paper presented to the AAO in Washington, D.C. on OJW

AJODO and JADA

AMERICAN JOURNAL OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS

AND JOURNAL OF THE AMERICAN DENTAL ASSOCIATION

Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity

by

Ted Rothstein, DDS, PhD

Brooklyn, NY

COVER LETTER 

To the Members of the Manuscript Central Review Committee:

    In preparing this manuscript it was necessary to cite original work which appears only at my web site drted.com. URLs cited there were archived at http://www.webcitation.org  following the publisher's guidelines.

I took special note of one jury member's  "No ethical board review approval was obtained prior to performing the survey

I would like the  committed to know that in response to this criticism I contacted Ms. Terri Majors, President/Administrator of the Ethical Review committee who assured in her letter to me dated March 10. 2009 that "No, you do not need to obtain IRB approval prior to surveying your patients"  [terrim@ethicalreview.com].

The cover story in the November, 2010 JADA indicates that some dental professionals are already providing services to the obese. However most have refrained
for fear that their patients may find them "judgmental". If we let the obese know about our changing attitudes they will come to us, as my own experience and research has proven.

"Orthodontic Jaw Wiring (OJW®): The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity" is an article concerning a new service that dentists should consider providing to obese patients who seek them out. As the sole developer of Orthodontic Jaw Wiring for weight control and provider of the service since 1998 I feel confident that this service will improve the image of dentists and dentistry, albeit a discipline seemingly on the fringe of the usual and customary services members of our profession typically provide.
Given that we are the caretakers of the mouth and uniquely empowered with skills and mechano-therapy to provide services to the overweight, it is our obligation and responsibility as part of a health-care team to provide our expertise to the overweight heading towards obesity and those who have already reached that state.
OJW patients will applaud and praise our efforts to help them; they will not begrudge us if they regain the weight post-treatment, a problem encountered with every weight-loss method without exception. Weight loss is not the OJW provider’s prime responsibility. OJW providers are primarily responsible for the maintenance of the health of the TMJ, dentition and gingiva during the period of being wired. If members of the dental profession step forward and recognize their right and responsibility to care for selected patients who meet the criteria of being overweight or obese, based on the diagnosis of the patient’s physician, the leaders of the ADA and AAO will be obliged to clearly define the dental professional’s role in providing this service just as they did when problems of snoring and sleep apnea first came to the attention of dental professionals.
I am confident that in time OJW will become a service that members of the dental community will provide with satisfaction in their own communities. I have no doubt that there will never cease to be members of the dental and medical community who look upon OJW with a jaundiced eye. I say offer the service, choose our patients carefully, do the OJW methodically and be responsive to our patient's needs. Most of the compulsively overweight will applaud our efforts to help them and they will not hold it against us if they regain the weight.

Yours truly,
Ted Rothstein, DDS, PhD

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Acknowledgments

To my staff past and present; those who encouraged and cheered, and above all, the OJW patients who were always enthusiastic and tireless in their efforts to regain control of their compulsive eating habits.

 

_________________________________________________________________________________________________________________________________________

Dedication

To my colleagues; wife Frances; sons Lenard and Jonathan, and bother Jerry.

_________________________________________________________________________________________________________________________________________

ABSTRACT 
    Obesity is legion and epidemic in our country, and becoming worldwide in developed countries. It is recognized as a precursor to a host of serious illnesses. Indeed,
Medicare and Medicaid have classified obesity per se as a disease. Orthodontic Jaw Wiring (OJW) utilizing brackets bonded to the canines and premolars and inter-occlusal wiring between upper and lower teeth is used to control weight by limiting jaw opening. OJW in conjunction with a liquid diet, is a far less invasive approach than gastric surgery to help obese patients avert its potentially grave consequences. OJW is applicable to those carefully selected individuals whose Body Mass Index (BMI) indicates they are overweight or obese as diagnosed by their physician. Twenty-four former OJW patients out of seventy-seven invitees responded to a lengthy in-depth survey. Their responses support the conclusion that OJW is largely safe and effective using a newly developed protocol to provide the service. The issues of aspiration and liability are important concerns. It is our obligation and responsibility as part of a health-care team to provide this service to the overweight and already obese who would seek us out. Dental professionals may elect to incorporate OJW in to their armamentarium.________________________________________________________________________________________________________________________________________

 INTRODUCTION

    Obesity is now recognized as a disease by the A.M.A. It is a major healthcare problem affecting 35% of the United States population. In more affluent countries, obesity is common not only in the middle-aged, but is also becoming increasingly prevalent among younger adults and children and recognized as a precursor to a host of serious illnesses.1, 2, 3, 4, 5, 6, 7,7.5 Indeed, Medicaid and Medicare have classified obesity as a disease in itself. These agencies are seeking new and less expensive approaches to the costly lap-band and gastric bypass surgeries extant whose mortality rate reaches 3/1000.5  Dental professionals should pay particularly close attention to the fact that Medicare is now reimbursing private

physicians for supervising weight loss programs. Typically when Medicare begins to pay providers for a service private insurers quickly follow suit.5.5

 

      Orthodontic Jaw Wiring (OJW†) for weight control is an optional approach that can help some people who are obese, or on a path to obesity, avert its potentially grave consequences among which include airway impairment and sleep apnea, whose co-morbidities are myriad.3,8
     Dentists and orthodontists are taking cognizance of their role in the treatment of this problem, and in coordination with the patient’s physician,  can provide appropriate mechano-therapies.
8,9,10,11

    Moreover, the American Association of Orthodontists sanctioned such "not-strictly-orthodontic" interventions beginning in 2004 by offering liability coverage for the first time for treatment of sleep apnea. Formerly, the orthodontist’s and dental professional’s role in providing mechano-therapy was frowned upon, and neglected by the dental practitioners. This author has been providing this service since 1998 and in this article presents for consideration to members of the dental profession the data and experience accumulated.

     There are some fundamental questions the reader should pose:

1. What is OJW?
2. Is OJW within the scope of the dental profession?
3.
Is OJW safe?
4. Is weight loss resulting from jaw wiring new?

5. What innovations have the author introduced?
What is OJW?

    Orthodontic Jaw Wiring12, 13 refers to the entire domain of the OJW provider's responsibility to:

1. select patients according to specified criteria, and obtain their informed consent14 so that they are aware of the risks and limitations of OJW;

2. wire their jaws apart by a prescribed method;13 (See 3-5 below figures.)

Place Figs. 1-3; 6 photos below * 

Place 2 photographs here.

Fig, 1a. "Begg" brackets bonded on canines and premolars. 

Fig. 1b. Wiring accomplished either around the bracket slot as shown in Fig. 1b, or through the long axis of the bracket slot to extend the envelope of mandibular motion to 2.0mm-4.0+mm.

Place 2 photographs here.

Fig. 2a.  August 8, 2007, the case of M.M., BMI** 36.
Right and left sides are wired identically in the OJW position of physiologic rest*** using  012" dead-soft stainless steel wire consequently limiting the range of mandibular motion to 1.5mm-2.0mm in all excursions. Clear attachments on the upper canines were placed for cosmetic enhancement. Note the disto-axial inclination of the Begg brackets to facilitate wiring.

Fig. 2b. Demonstrates on a 3M-Unitek model of SmartClip® braces how "self-ligating" braces can be used as the attachments albeit more difficult for the patient to remove the wiring if/when need be.

Place 2 photographs here.

Fig. 3a and 3b  A 3M-Unitek SmartClip® model demonstrating OJW pari passu with orthodontic treatment by making use of the bracket's vertical elastic hooks to effectuate the wiring in a manner which increases the envelope of mandibular motion.

(cont'd from 2. above)

3. transmit that know-how to the patient or their significant other, especially when they are not able to return to the OJW provider, and cannot find a competent professional who will do it for them;

4. reexamine and rewire them, typically every five weeks, after examination demonstrates that their dentition, gingiva and TMJ have remained healthy over a period of time typically between three and nine months, during which time they will reduce weight by two pounds per week, and even more with exercise;

5. remove the wiring and brackets when patients indicate they have achieved their goal or desire to have the OJW device removed.

         OJW presumes the concerted efforts of the patient's primary health-care physician, who diagnoses the condition and provides the patient medical clearance to begin a liquid diet, their dentist who may or may not be the OJW provider, and when applicable a dietician, psychologist and/or psychotherapist and a bariatric surgeon when warranted.14

2. Is OJW within the scope of the dental profession?

    Dr. Milton Lawney, the Executive Secretary of the New York State Board of Dentistry responds:

 “If the condition is properly diagnosed and a lawful treatment plan is prescribed by a professional authorized to do so, the fitting and attaching of appliances could very well have dental health implications and a dentist may be involved in those services... It is not within the scope of dentistry to diagnose and treat independently the condition of obesity. Dental appliances aimed at weight loss may be prescribed if the condition is diagnosed by the proper authority.” -- Interpretation of Article 133 § 6601 – Dr. ML.15   The bylaws governing the practice of dentistry may differ among states.  However,  jaw wiring for weight loss is not specifically prohibited in any state to the best of the author's knowledge.

3. Is OJW safe?

    Jaw wiring for weight loss has been researched and found to be a safe procedure historically and as indicated by the present study.16, 17 Moreover, personal research in dental and medical literature as well as an extensive search of legal archives by an attorney fail to identify a single instance of harm coming from the jaw wiring itself.  If harm has come to a patient it has not been reported in the literature. Finally, interviews with more than a score of oral surgeons could not elicit a single instance of injury to a patient who had jaw wiring for trauma or pathology.17  This is significant because oral surgeons rigidly immobilize the jaws maximizing risk to the TMJ, gingiva and dentition, while in OJW the provider applies a relatively benign appliance which allows the mandible maximum mobility while precluding the ingestion of solid food and simultaneously permitting reasonably clear speech.

4. Is weight loss resulting from jaw wiring new?
     Oral surgeons often use "inter-maxillary fixation" to hold their patient's teeth/jaws rigidly together with surgical arch bars laced on with wires between the teeth to facilitate healing in trauma or pathology cases
. Consequently, those patients were required to exist on a liquid diet and frequently experienced a noticeable weight loss.

5. What innovations have the author introduced?

1. The inter-occlusal jaw wiring in OJW has been specifically used toward the goal of weight loss.18
2. The jaws are wired
in the OJW position of physiologic rest through the medium of orthodontic attachments bonded to the premolars and canines to limit but not totally inhibit mandibular movement vertically, laterally and antero-posteriorly.

3. A robust Informed Consent was created specifically for OJW. 14

4. A protocol was created which takes cognizance of the possibility of TMJ stiffening over time and the possibility of extrusion of teeth.13

5. A study was mounted (N=24) to assess how patients fared following the protocol.19

      OJW is highly controversial. 12, 20 It has provoked some professional colleagues to declare that it is an inappropriate treatment modality for dental professionals to provide,12 when in fact it is minimally-invasive and has been shown to be largely safe and effective21 unlike gastric surgery with its substantial cost, high mortality rate5 and post-operative surgical complications.2,5 Indeed, efforts to promote the appropriateness of such a service provided by members of the dental profession has sparked vigorous debate and opposing views.12,20

      The "orthodontic" approach to jaw wiring was conceived of as a minimally invasive method applicable to carefully selected individuals15 whose Body Mass Index (BMI) indicates they are overweight or obese as diagnosed by their physician.

The orthodontic approach is so called because it makes use of orthodontic attachments bonded to the teeth, and the protocol requires the patient to return every five weeks to be examined and rewired. Moreover, in some cases, it can be provided pari passu with orthodontic treatment 22 and finally because it is possible to segue directly from active orthodontic treatment into OJW.

     Dental professionals are increasingly cognizant of their new role as shown by the advent four years ago of a removable appliance called the DDS System and, most recently, a fixed device invented by Jan Renders in conjunction with an orthodontist, Rene Linders, ready for clinical trials in Philadelphia.3,6,7,9,10,11 Moreover, Jackson University is undertaking a research project to determine if the orthodontic office is an appropriate venue to address childhood obesity.

REVIEW OF THE LITERATURE

    There are few articles in the Medical literature.16 and none at all in the scientific dental literature. Moscowitz wrote in an editorial that dental professionals had no place to assist those who were "morbidly" obese (BMI ≥ 40 e.g., 5'8”, 260 pounds).23   I agree with him. The morbidly obese, with rare exception, are beyond the scope of the dental profession's assistance. They are now candidates for high-mortality bariatric surgery. Our role is to help those who are not as yet morbidly obese, and who seek us as the last conservative approach before gastric bypass surgery. Moscowitz on the other hand concluded that while OJW patients might benefit from OJW to "jump start" a diet, regaining the weight renders it a useless tool to approach this multi-factorial problem. Moreover, "jaw wiring" in already medically compromised obese patients may result in irreversible harm and possibly death.12,20  He is right again. Finally, aspiration of vomitus has always been a serious adverse concern in any jaw-wiring efforts". 

     However, there are no reports supporting his claim anywhere in the dental literature (in particular, the literature published by oral surgeons) of such an occurrence. Indeed, OJW has its own built-in safeguards such as: pre-treatment screening with a comprehensive Informed Consent, and a list of contraindications that would allow a provider of this service to select appropriate candidates. Jerrold stated, 20 "Certainly, obesity is the number one health risk in our society today. and is increasingly reflected among the orthodontic patient demographic. For this reason alone, if there is anything that we can do to help address the health issue, we should take part in the treatment process, but only in conjunction with concurrent medical oversight."  Freeman concludes that "with proper informed consent...good screening of OJW candidates, good dentistry etc, the risk of loss is likely not higher than any other dental procedure".20 Absent any studies, the author implemented the present study employing the null hypothesis that OJW is neither safe or effective.19

General conclusions of the Medical and Dental literature review:16

1. Jaw wiring in conjunction with a liquid diet is generally accepted by the medical community as a therapeutically effective method to lose weight.

2.  Liquid diets are considered to be safe.24, 25

3. The only study of jaw wiring on teeth, gums and jaw joints per se shows that this procedure has no permanent harmful effects.21

4. The regaining of weight lost is common; behavior modification that results in long-term maintenance of weight loss is extremely important.26

5. There are no studies that have examined the health of the TMJ using a long-term protocol requiring immobilization-rest/exercise and immobilization over a period of time as long as six to nine months as the OJW protocol advocates, viz. five weeks wired followed by five days unwired allowing full range joint mobility, and rewiring for another five weeks, etc. Research on jaw wiring has been neglected by dentists and orthodontists for lack of a protocol and an Informed Consent, leading to serious concerns about providing OJW with regard to medico-dental and liability issues.14

6. Dentists and orthodontists are uniquely capable of providing the OJW service.27

METHOD OF THE STUDY

    An invitation to take a seventy-seven question survey was sent to seventy-five former OJW patients who were by and large patients who came for the service from out-of-state as a result of searching the Web for "jaw wiring". They were accepted as "good candidates" (no compromising dental or medical problems) after a review of the Informed Consent, the dental-medical history and the typical orthodontic forms they were requested to submit.

 Twenty-four people chose to participate.  The study was partitioned in to the following areas of interest: 1.  INVITATION TO TAKE THE SURVEY   2.  DEMOGRAPHIC QUESTIONS (1-3)   3.  BACKGROUND OF PATIENTS (4-21)    4.  SAFETY OF OJW (21-30)   5.  EFFECTIVENESS AND BENEFITS (31-40)    6.  PROBLEMS OF OJW (41-55)  7. CONCLUSIONS (56-73)    8.  MISCELLANEOUS (74-77) .  The details of each question and the responses were posted to the World Wide Web.19

RESULTS

    The twenty-four respondents came from everywhere in the United States, mainly because there were no other providers for the service.

The preponderance of patients were females between 24 and 44 years of age 75% of whom reported were still in OJW and whose average starting weight was 230 pounds, approximating a BMI of 36. They or their significant other were instructed how to accomplish the rewiring following the protocol for OJW wiring: five weeks wired, five days unwired, then rewired if their joint did not feel stiff for five more weeks . 

    They reported their present weight as a group to be 193 pounds representing a BMI of 32.7. They reported suffering most often pain and discomfort in knees and or hips, followed by depression, snoring, sleep apnea and finally, lower back pain. Risk and/or fear of surgery were important in choosing OJW. 85% of them reported it was impossible to find another OJW provider. 70% had been in OJW for less than seven months. 78% indicated that the OJW service was highly valuable, and 83% of the sample said it helped them to get better control of their eating habits.

    The problems they reported: The inside of my mouth felt unclean, 56%. My jaw got stiff, 44%.  Speech was impaired too much, 31%; it was too costly, 31%.  However, their social and sex lives were not impacted to any great extent. 21%, reported stiff and or painful jaws. Indeed, 21% answered that they "gave up on OJW because the jaw joint become stiff or painful". 84% of respondents felt they "did not make a big mistake by choosing OJW and that it was not a waste of time and money." 

    Surprisingly, 84% reported that having to rewire themselves was not a problem. 94.4 % of the respondents indicated that regarding rewiring themselves: "I might have continued if an easier method to rewire myself was available" indicating that for most having to rewire themselves was not an issue.  The author does not advocate that OJW patients be encouraged to rewire themselves.  Indeed, it is always preferable to have the patient return to be examined and rewired by the OJW provider.

    Question 58 was considered most important:  Given that vomiting could lead to the aspiration of vomit back into your airway leading to effects ranging from choking to death, please state your position(s) from the list below (17 respondents reported) The Informed Consent I filled out told me all I needed to know, (58.8%).  It's possible but highly unlikely, (41.2%).  The risk of death from surgery bothers me more, (23.5%).  You can die from some diet pills as well, (23.5%). I carefully researched that possibility and found no instance of its occurrence, (29.4%).  I was warned of that so I carried my wire clippers with me at all times, (47.1%0.   All of the above, (47.1%). Question 62 was also of interest: Do you believe that OJW gave you a "jump start" with your weight loss efforts? To which 16 of 20 patients responded affirmatively. 

    The responses to question 63 Why did you choose the OJW method to begin with revealed that My being overweight was causing me to be depressed (83%).  I felt this approach might help me bring my compulsive overeating under control, (72%). I realized that my excessive weight could have serious health-related consequences, (67%).  I was finally able to locate a dental professional who would provide the service, (61%).  I just didn't like the way I looked and previous methods were ineffective for me, (56%). Overall, more than 90% approved and recommended OJW. In response to question 69, If you did regain the weight you lost did you hold the OJW provider responsible? 90% reported "No". 

    Finally, in response to: If you did have an experience related to OJW with special attention to nausea, vomiting or choking please comment here: All respondents except four offered no response to this question. The four who did said "not applicable". 

 DISCUSSION AND CONCLUSIONS

     I have provided OJW to many patients without incident and with great success depending on how success is defined. If it is measured by whether the patient achieved permanent behavior modification regarding eating and exercise habits, I cannot say assuredly that OJW was a success. However, if it is measured by gratitude expressed and weight lost, it was.28
    OJW providers are responsible for the maintenance of the health of the TMJ, dentition and gingiva, but not responsible for weight loss per se.

    Patient awareness of choking and aspiration of vomit is accomplished by the Informed Consent. There are no reports of this occurring in the literature.

    Screening patients for selection is critical, and medical clearance to begin a low-calorie liquid diet is mandatory.

    Given that we are the primary caretakers of the mouth and endowed with the skills and a choice of mechano-therapies to provide services to the overweight, we ought to be actively engaged in disseminating information in our offices and providing services to those who seek it.  Other health professions30 should be made aware that we dental professionals are part of the health-care team already serving the overweight heading towards obesity as well as those who have already attained obesity with its attendant co-morbidities.

    The health-care team includes: weight-control hospital clinics, general practice physicians/internists, bariatric surgeons, registered dieticians and psychotherapeutic counselors.27

     If members of the dental profession step forward and recognize their right and responsibility to care for selected patients who meet the criteria of being overweight or obese, based on a diagnosis of the patient’s physician, the leaders of the American Dental Association and AAO will be obliged to clearly define the dental professional’s role providing this service just as they did when problems of snoring and sleep apnea first came to the attention of dental professionals, and the AAO responded by clarifying the conditions under which clinicians who provided the service would have liability insurance coverage.32

    Finally, OJW patients will applaud and praise your effort to help them; they will not begrudge you if they regain the weight post-treatment,19 a problem encountered with every weight-loss method without exception. Based on my clinical experiences since 1998 I would encourage dental professionals to consider OJW as a service to selected patients. OJW seems to be a safe and effective way to help some compulsive overeaters . It should be part of our armamentarium and providers are recommended to follow guidelines proposed by the author.31

REFERENCES

WILL ADD:  

Curran A. et al.  Dentists’ Attitudes About Their Role in Addressing Obesity in Patients. Journal of the American Dental Association November, 2010, Vol. 141:11, pp. 1307-1316)..."More than one-half of the respondents cited fears of offending patients (53.8 percent) and appearing judgmental (52 percent) as major barriers"

Mughal, Rabia  Associate Editor  Editorial Online Journal DrBicuspid.com: What's stopping dentists from talking about obesity?  November 16, 2010

 

1. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report First guidelines developed by the Federal Government to address overweight and obesity-conditions that affect an estimated 97 million Americans and are the second leading cause of preventable death in the United States. NHLBI Report. National Heart Lung and Blood Institute. . 2009-02-10. URL:http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.htm. Accessed: 2009-02- (Archived by WebCite® at http://www.webcitation.org/5eU4YNsTu)

 

2. Freudenheim L. Other perils of overweight. New York Times, 2005: May 27. C1.

 

3. Davidson TM. The role of the dental professional in the diagnosis and treatment of Sleep-disordered breathing. Dentistry Today, 2005; September, p.118.

 

4. Freking K. Obesity rates climbing. Amhealth. 2005; p. 24, August 24.
 

5. Kolata G, Grady D, . Weight-loss field awaits change in Medicare policy. New York Times. 2009-02-09. URL:http://drted.com/OJW insurance coverage.htm. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eTL46lmI)

5.5. Newman A.  Enticing Doctors to Endorse a Weight-Loss Program. New York Times. December 28, 2011 B. p 3.
 
6. Young-soo S. Regional Director of the World Health Organization: Manilla . 2009-02-09. URL:http://www.wpro.who.int/health_topics/obesity/. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eTTCaLRW)
 

7.  Loyd L. Fighting against obesity one bite at a time. The Philadelphia Inquirer, 2007; Sept. 17, Business Section D5.

 

7.5. Pollock A. A.M.A. Recognizes Obesity as a Disease. NY Times, p. 1, Business Section, June 19, 2013.

 

8 New 8) Curran A. et al.  Dentists’ Attitudes About Their Role in Addressing Obesity in Patients. Journal of the American Dental Association November, 2010, Vol. 141:11, pp. 1307-1316)..."More than one-half of the respondents cited fears of offending patients (53.8 percent) and appearing judgmental (52 percent) as major barriers"
 

8. (Prior to Curran) Thirty Diseases and Side Effects for Obesity. Tips for Life.com. 2009-02-11. URL:http://www.tipsinlife.com/weight-loss-diseases.htm. Accessed: 2009-02-11. (Archived by WebCite® at http://www.webcitation.org/5eVVKMLJW)
 

9. Malmache L. Help your patients eat less! Dental Economics, August 2004 in “columns.” (re the DDS System).

10. Renders J. et al. United States patent #6,138,679, A method suitable for influencing the ingestion of food by humans via the mouth cavity. October 31, 2000.11

11. Florman MJ. Oral appliance and method for use in weight loss and control. Application for a utility patent submitted to the USPTO, 2003: April 24. Application abandoned.
 

12. Rothstein T. Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity. 2009-02-09. URL:http://www.drted.com/index.html.bak2/Jaw wiring pros and cons.htm. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eTF7zozH)
 

13. Rothstein T. The protocol for providing OJW Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity. 2007-06-07. URL:http://www.drted.com/ojw_protocol.htm. Accessed: 2009-02-10. (Archived by WebCite® at http://www.webcitation.org/5eUI44dFg)

 

14.Rothstein T. Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity. 2009-02-09. URL:http://www.drted.com/index.html.bak2/Jaw wiring Informed Consent.htm. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eT6afCic)

15. Rothstein T. Is jaw wiring within the scope of dentistry?. Rothstein T. 2009-02-11. URL:http://www.drted.com/OJW The question.html. Accessed: 2009-02-11. (Archived by WebCite® at http://www.webcitation.org/5eVc0kaon)

16. Rothstein T. Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity. 2009-02-09. URL:http://www.drted.com/index.html.bak2/Jaw wiring for weight loss literature references.htm. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eTEc34hS)

17. Shephard BC, Townsend GC, Goss AN. The oral effects of prolonged inter-maxillary fixation by inter-dental eyelet wiring. Int. J Oral Surg,1982 Oct;11(5):292-8.

18. Rothstein T. PowerPoint presentation Greater NY Dental meeting. 2009-02-11. URL:http://www.drted.com/OJW DPOJW PPP.ppt. Accessed: 2009-02-11. (Archived by WebCite® at http://www.webcitation.org/5eVeHxvao)

19. Rothstein T. Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity. 2009-02-09. URL:http://www.drted.com/ojw_questionnaire_survey.htm. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eTRYD0zF) The Safety and Effectiveness of, and the Problems Associated with, OJW--a weight-control method

20. Piehler C. Orthodontic Jaw Wiring: A Roundtable on a controversial weight-loss procedure.. Orthodontic Products Magazine. 2009-02-09. URL:http://www.drted.com/OJW Roundtable article OPM PDF.pdf. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eTB772rr)

21. Rogers S. et al. Jaw wiring in treatment of obesity. The Lancet, p. 1221, 1977; June 11. p. 1221.

 

22. Rothstein T. Combined OJW and orthodontic treatment. . 2009-02-11. URL:http://www.drted.com/Iris Pierre OJW n Ortho.htm. Accessed: 2009-02-11. (Archived by WebCite® at http://www.webcitation.org/5eVhCnozy)

23. Moskowitz E. The Limits of Dentistry editorial, 70 #9, p.3 NYS Dental Journal, December 2004.

24. Brody JE. Study finds a liquid diet works (but not for the 50% who quit it. New York Times Science Section, 1992: May15. http://www.drted.com/Liquid diet Brody article.html

25. Wadden TA. Treatment of Obesity by Moderate and Severe Caloric Restriction: Results of Clinical Research Trials, NIMH grant RO1-MH49451-01 Annals of Internal Medicine, October 1993, V.119, issue 7, Part 2, pp. 688-93.26. Garrow JS, Gardiner, GT. Maintenance of weight loss in obese patients after jaw wiring. Br Med J (Clin Res Ed) 1981 Mar. 14; 282(6267):858-60.

26. Wadden TA, Foster GD, Letizia KA, Stunkard AJ. A multi-center evaluation of a proprietary weight reduction program for the treatment of marked obesity. Arch Intern Med 1992;152:961-966.

27 Rothstein T. A letter to orthodontic colleagues summarizing the rational for embracing OJW: Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity. 2003-22-09. URL:http://www.drted.com/OJW protocol report.htm . Accessed: 2009-02-10. (Archived by WebCite® at http://www.webcitation.org/5eU7XtQTt)

28. Rothstein T. What is success to an OJW patient. 2009-02-13. URL: http://www.drted.com/OJW Julie to Robin.html. Accessed: 2009-02-13. (Archived by WebCite® at http://www.webcitation.org/5eZTg0SDv)
 

29. Rothstein T. Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity. 2009-02-09. URL:http://www.drted.com/Responses to ojw questionnaire survey.htm. Accessed: 2009-02-09. (Archived by WebCite® at http://www.webcitation.org/5eTPdY2yc)
 

30. Rothstein T. Letter sent to twenty bariatric surgeons indicating their consideration of OJW as a viable antecedent to gastric surgery.  2009-02-13. URL:http://www.drted.com/DPOJW note Bariatric Surgeons.html. Accessed: 2009-02-13. (Archived by WebCite® at http://www.webcitation.org/5eZSUokNt)
 

31. Rothstein T. Principles and Guidelines for providing OJW. 2009-02-13. URL:http://www.drted.com/Jaw wiring principles for providers.html. Accessed: 2009-02-13. (Archived by WebCite® at http://www.webcitation.org/5eZUZxbPk)
 
32. Jerrold L, Freeman J, Rothstein T, Perspectives on Medico-Legal Issues. . 2009-02-14. URL:http://www.drted.com/OJW protocol report responses.html. Accessed: 2009-02-14. (Archived by WebCite® at http://www.webcitation.org/5eZbtZLwa)

__________________________________________________________________________________________________________________________________________

 † Patent pending USPTO # 11/ 534,225 

*3 Figures;  6 Photographic illustrations

                              Fig. 1a                                                           Fig.1b

 

                              Fig. 2a                                                          Fig. 2b

                           Fig. 3a                                                               Fig. 3b

** Calculation of BMI:
Measure your height in inches (without shoes) and your weight in pounds (without clothing). Multiply your weight by 703. Then divide that number by your height.    Divide again by your height.
These categories were established after several studies examined the BMIs of millions of people and correlated them with rates of illness and death. The studies showed that the BMI range associated with the lowest rate of illness and death is approximately 19–25 in men and 18–25 in women, so people with BMIs in this healthiest range are considered to be of normal weight. Higher BMIs are associated with progressively higher rates of illness and death. People with BMIs of 25–30 are considered overweight, and those with BMIs of 30 or higher are considered obese. Obesity has recently been further subdivided into mild (BMI of 30–35), moderate (35–40) and severe (BMI of 40 and above). Severe obesity is roughly equivalent to being 80 pounds overweight if you are a woman or 100 pounds if you are a man.  Or go to
http://www.nhlbisupport.com/bmi 

***  Rothstein's The OJW position of physiologic rest:
 Is a parted resting position of the mandible at which the muscles of mastication are in a minimally contracted position thereby allowing the lower jaw to be suspended from the maxillary teeth in a condition of  "weightlessness". Inter-occlusal  OJW wiring permits the mandible to move  2.0mm - 4.0mm laterally, vertically and antero-posteriorly  thereby minimally impeding speech and minimizing the possibility of temporo-mandibular joint (TMJ) stiffening. This position is often congruent with an observable inter-occlusal space of 2.0mm - 4.0mm and closely approximates the position we know as the "physiologic jaw resting"  position, the initial position  from which all jaw excursions begin.
It is this condition of  jaw "weightlessness" that precludes the possibility that the upper/lower teeth are extruded during the time the OJW device is in place.  See also: Understanding the OJW Position of Physiologic Rest

*

Ted Rothstein, DDS, PhD

Private practice Orthodontist for Adults and Children

Life-active member American Association of Orthodontists

35 Remsen St.

Brooklyn, NY 11201

(718) 852-1551   Fx  852-1894

drted35@aol.com     www.drted.com

TABLE OF CONTENTS

ACKNOWLEDGMENT

DEDICATION

TITLE PAGE

COVER LETTER

ABSTRACT

 INTRODUCTION

        FIVE FUNDAMENTAL QUESTIONS

        RESPONSES TO FUNDAMENTAL QUESTIONS

        CAPTIONS FOR THREE FIGURES; 6 PHOTOGRAPHIC ILLUSTRATIONS

  REVIEW OF THE LITERATURE

     General conclusions of the literature review

METHOD OF THE STUDY

RESULTS

DISCUSSION AND CONCLUSIONS

REFERENCES

     *FIGURES (3 FIGURES; 6 PHOTOGRAPH ILLUSTRATIONS)

   **CALCULATION OF BMI
   ***DEFINITION OF
The OJW position of physiologic rest
CONTACT INFORMATION

KEY WORDS:
Dentistry; National Health; Obesity; Medicaid; Compulsive overeating; Health risks of Obesity; Weight loss; Orthodontic jaw wiring; Dental jaw wiring; Orthodontic Appliances  

WORD COUNT: 3124

SUBMISSION DATE:  SUNDAY, FEBRUARY 15, 2009

 
 Manuscript Rejected:
 

From:

mglick@atsu.edu

To:

drted35@aol.com

CC:

 

Subject:

JADA - Decision on Manuscript ID 077-09

Body:

18-Feb-2009

Dear Dr. Rothstein:

I write you in regards to manuscript # 077-09 entitled "Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity" which you submitted to The Journal of the American Dental Association.

Manuscripts submitted for publication are sent for critical evaluation and comment to selected reviewers who are recognized authorities in their specialized fields. On the basis of the reviewers' comments and our current backlog of manuscripts, your manuscript cannot be given sufficient priority for publication in The Journal.

Thank you for considering The Journal of the American Dental Association for the publication of your manuscript. I hope the outcome of this specific submission will not discourage you from the submission of future manuscripts.

Respectfully,
Dr. Michael Glick
Editor, The Journal of the American Dental Association
jadaoffice@ada.org


Reviewer(s)' Comments to Author:
No ethical board review approval was obtained prior to performing the survey.

Date Sent:

18-Feb-2009

Terri

------

Terri Majors, President/Administrator

Ethical Review Committee

14400 E. 42nd St., Suite 240

Independence, MO  64055

Phone: (816) 421-0008

Fax: (816) 356-2227
 

In a message dated 3/10/2009 6:41:51 P.M. Eastern Daylight Time, terrim@ethicalreview.com writes:

Good afternoon, Dr. Rothstein,

 
As the administrator of an Independent IRB, I will attempt to answer your questions.  I understand your frustration at the situation and it is not the first time we have been approached by others that have found themselves in the same position.  

 
The Ethical Review Committee has been in business over 20 years to serve the needs of the private sector researcher, individually as well as corporate pharma.  Not all research takes place in the institutional setting so the independent review board is needed to meet the FDA regulations for those research trials.  The Institutions are regulated by the Office of Research Protection (OHRP) which is a division of DHHS and is often linked with federal funding and the requirements associated with that funding. 

 
In response to your question on whether the fact that you are NOT associated with any institution remove you from the IRB review requirement.  No it does not.  The determination of whether you are required to have an IRB review prior to starting the research is based on the kind of research you are planning to conduct and what you intend to do with the resulting data.  However, from the information you have provided, it would appear that under FDA regulations, an IRB review is not required.  The rules for this type of research are different between OHRP and FDA.
 
Within the OHRP there are a variety of types of research, including social/behavioral studies. Under OHRP, there are studies that can be determined to be "exempt" from IRB review.  This is applicable ONLY in the institutional setting and does not apply to the private sector.   Private research is regulated by the FDA and the FDA does not have a classification of "exempt research."    In fact, the survey that you have outlined does not  meet the FDA definition of "research."   So, in response to your first question:  No, you do not need to obtain IRB approval prior to surveying your patients.
 
However, the climate of research has changed over recent years.  What seems to be the decision maker, is how you intend to use the data collected.  This is where the real problem lies.  The FDA regulations do not allow for studies that can be classified as "exempt".  The regulations, in fact, do not even speak to social/behavior studies.  The requirement for IRB review seems to be driven by the journals as a requirement for publication.  It indicates that an independent body reviewed the protocol and consent form and applied the same research criteria tests as FDA regulated research.  
 
The Ethical Review Committee has responded to this increase in requests for review of social/behavior/outcome based studies, which includes data collection survey studies like yours as well as other "less than minimal risk" classification studies, by providing an "expedited review" of the protocol and consent  prior to the conduct of the study.  These reviews are conducted within the criteria of FDA regulations and guidance for research, even though we are aware that review of these type of studies is not required by the FDA.  This type of review of the basic data collection protocol  may be beneficial if further research is developed from the information collected and it appears to give the credibility needed for the journals to accept the data for publication.
 
It was my understanding that not all journals require an IRB review before accepting articles.  However, as we are not involved in the publication of any research results I cannot speak to this issue with credibility.
 
The Ethical Review Committee's SOPs do not allow for the approval of a study after the study is completed.  However, the  ERC may be able to provide an opinion letter stating that the study did not meet the definition of research  and did not require an IRB approval  under the FDA regulations following review.  It would not be an "exemption" as the FDA does not recognize exemptions.   I am not sure if this opinion letter would assist in gaining acceptance into a journal or not. 
 
 Hope this helps with the confusion.  If we can provide additional service to you, please let me know.
 
Regards,
Terri
Terri Majors,President/Administrator
Ethical Review Committee
14400 E. 42nd St., Suite 240
Independence, MO  64055
Phone: (816) 421-0008
Fax: (816) 356-2227 
Dear Terri;
 
Thank you very much. I appreciate your thorough coverage of the topic. Cordially, Dr. Ted Rothstein
 
Cc: Respected Colleague

You are welcome.  We are aware that it can feel like moving through a minefield.

 If we can be of further assistance, or if you would like additional information regarding the ERC, please let us know.  
 
Regards,
 
On Mar 10, 2009, at 10:21 AM, Drted35@aol.com wrote:
 Would one of you kindly address this serious concern
 
 
 Ted Rothstein, DDS, PhD
 Orthodontist for Adults and Children
American Association of Orthodontists

Founder DPOJW www.drted.com/DPOJW.html
35 Remsen St., Brooklyn, NY 11201
718 852 1551    Fx 718 852 1894 drted35@aol.com     www.drted.com

 
 
Re: Exemptions from need to obtain an ERB/IRC  
 
To Whom it may concern:
 
I am a private practitioner in the field of orthodontics. I AM NOT ASSOCIATED WITH ANY INSTITUTION.
 
Am I required to get a prior approval from IRB  to survey my patients with regard to the benefits and problems of a service that I provided. http://drted.com/OJW JADA manuscript 020509.htm
 
Those who responded to the survey were private patients who received the service (Orthodontic Jaw Wiring for the control of Compulsive overeating) provided by me alone.
 
Consent was provided by all participants in the survey. 
 
An article I submitted to a journal was rejected because I did not proactively submit my survey for such an approval. The manuscript:  http://drted.com/OJW JADA manuscript 020509.htm
 
I am told by a leading researcher and authority in my field  I was not obliged to obtain such approval  precisely because I AM NOT ASSOCIATED WITH ANY INSTITUTION.
 
 Is this correct?
 
Dr. Ted Rothstein DDS, PhD
 
Cc: multiple staff members

 
15-Feb-2009
Dear Dr. Rothstein:
Your manuscript entitled "Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity" has been successfully submitted online and is presently being given full consideration for publication in the The Journal of the American Dental Association.
We will consider your article for publication with the understanding that
- it has not been published previously;
- it has been submitted solely to JADA;
- each author has fully disclosed any financial, economic or other conflicting interests in products or services described in the article.
Before we can put the manuscript into review, we need copies of the Copyright Transfer and Conflict of Interest forms signed by all authors. Please ensure that all authors sign these (you may make copies as necessary) and return them to us by mail or by fax at 1-480-219-6102, (you may disregard this request if you already have submitted the necessary forms with all authors' signatures).  If your manuscript is not accepted for publication, all rights will revert to you, and we will destroy the forms and remove your manuscript materials from our active database permanently.
Your manuscript ID is 077-09.
Please mention the above manuscript ID in all future correspondence or when calling the office for questions. If there are any changes in your street address or e-mail address, please log in to Manuscript Central at https://mc.manuscriptcentral.com/jada  and edit your user information as appropriate.  You can also view the status of your manuscript at any time by checking your Author Center after logging in to https://mc.manuscriptcentral.com/jada .
A decision regarding the disposition of the manuscript will be made after critical evaluation and advisory comment by selected reviewers.
Thank you for submitting your manuscript to The Journal of the American Dental Association.
Respectfully,
The Journal of the American Dental Association Editorial Office

Manuscript ID:

077-09

Title:

Orthodontic Jaw Wiring: The Dental Professional’s Role in Weight Control for Compulsive Overeating Leading to Obesity

Authors:

Rothstein, Ted

Date Submitted:

15-Feb-2009

 

Illustrations. A maximum of four figures—charts, graphs or photographs—and four tables may be submitted. (See next paragraph for an exception to this rule.) Each separate chart, graph or photograph will be counted as a separate illustration; illustrations should not be grouped together as a single illustration. Tables and figures should augment, not repeat, the text. Figures and tables should be numbered consecutively according to the order in which they are cited in the text. Regarding clinical figures, JADA will accept only digital files of at least 4 inches (roughly 100 millimeters) in width and at least 300 or more dots per inch and in JPEG, TIFF or EPS format.

 

Publisher's guidelines:
  • Periodical
    1. Lauterbach M, Martins IP, Castro-Caldas A, et al. Neurological outcomes in children with and without amalgam-related mercury exposure: seven years of longitudinal observations in a randomized trial. JADA 2008;139(2):138-145.
     
  • Book
    2. Cohen S, Burns RC. Pathways of the pulp. 8th ed. St. Louis: Mosby; 2002:196.
     
  • Book chapter
    3. Byrne BE, Tibbetts LS. Conscious sedation and agents for the control of anxiety. In: Ciancio SG, ed. ADA Guide to Dental Therapeutics. 3rd ed. Chicago: American Dental Association; 2003:17-53.
     
  • Government publication
    4. Medicine for the public: Women’s health research. Bethesda, Md.: U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health; 2001. DHHS publication 02-4971.
     
  • World Wide Web site
    5. Hoffman ED, Klees BS, Curtis CA. Brief summaries of Medicare & Medicaid: Title XVIII and Title XIX of the Social Security Act as of November 1, 2007. Baltimore, Md.: U.S. Department of Health and Human Services, Center for Medicare & Medicaid Services, Office of the Actuary; 2007. “http://www.cms.hhs.gov/
    MedicareProgramRatesStats/downloads/MedicareMedicaidSummaries2007.pdf”. Accessed Aug. 28, 2008.
     
  • Publication in press
    6. McCoy J. Alteration in periodontal status as an indicator of general health. JADA (in press). NOTE: Authors should double-check the status of any in-press work cited in their reference lists before submitting the final manuscript to JADA.
     
  • Presentation
    7. Eichenstadt L, Brenner T. Caries levels among low-income children: report of a three-year study. Paper presented at: 146th Annual Session of the American Dental Association; Oct. 7, 2005; Philadelphia.

 

 

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