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Prefabricated-oral-devices-not-useful-for-sleep-apnea
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Comments
Location: Bensheim, Germany
Efficacy of prefabricated oral appliances proven by various clinical trials
Broadcasting misleading and undifferentiated information such as „Prefabricated thermoplastic oral appliances for mandibular advancement are not effective for treating mild sleep apnea, and clinicians should use custom-made devices instead, new research suggests“ means an intended manipulation of the public’s opininon and that of medical experts to favour the extremely expensive custom-made oral appliances against the cheap prefabricated devices for he following reasons:
1. The authors of the cited study publication compared just one single custom-made oral appliance from the Swedish co-author Marie Marklund against just one single former prefabricated development product that never has been available in any market. Development of the prefabricated oral device project was finally ceased by mid of 2004, i.e. already 4 years before the publication of the study. The study investigators had been informed about the abandonment of the development project still at a very early stage of their comparative cross-over trial towards autumn 2004. The global approach of the conclusions is considered inappropriate and misleading, since there are many one-part (e.g. the classic SomnoGuard, Snorban, the test device from Prof. Hinz mentioned thereafter in the following chapter) and two-part (e.g. (e.g. SomnoGuard AP, Respironics Silencer, TheraSnore, SomnoFit) prefabricated oral appliances available in the market.
In principal, we do not mind the study results, however the facts and conclusions should be scienti-fically precise enough, not misleading and refer only to the two specifically examined appliances.
2. The co-author Marklund invented and is marketing predominantly in Sweden her custom-made appliance described in the publication cited by Reuters Health. It is Mrs. Marklund’s commercial appliance that had been compared to a former non-commercial product from Tomed. It is not made clear in the publication that Mrs. Marklund compares her own appliance against a no more existing former prefabricated development device to enable readers to draw their own conclusions about the neutrality of the study. Conclusively, Mrs. Marklund involved in the study as a product supplier, investigator and author had written her own publication for the purpose of promoting her custom-made device and to combat the commercial line of Tomed’s series of oral appliances which had not been involved at all in that study.
3. Authors state that there had been no previous studies comparing the efficacy of custom-made and prefabricated devices. This statement is clearly untrue. I had made available to the authors Vanderveken, Braem and Van de Heyning a publication from the authors Wigand et al. on 25 Oct. 2006 describing the strongly correlating clinical trial outcome of a custom-made and a prefabricated device. These devices are manufactured by the German orthodontist Prof. Rolf Hinz (reference: Wigand T, Verlaan S, Niemann A, Konermann M, Prädiktoren der Wirksamkeit endgültiger Schnarchtherapiegeräte, SomnoJournal 2005, 1: 10 – 12).
4. There are many clinical trials referring to the efficacy of prefabricated commercial oral appliances for the treatment of snoring and sleep apnea in adult patients. Some very positive clinical trial outcome data regarding the own commercial FDA 510(k) approved SomnoGuard series of oral appliances are referred to under www.tomedcare.com/index.php?212 (note: some more serious clinical trials referring to the one-part SomnoGuard and the two-part SomnoGuard AP have been finished in the meantime and are expected to be published soon). Vanderveken and colleagues hide in their recent publication even their own very positive clinical trial outcome data regarding the commercial one-part SomnoGuard presented by Vanderveken himself on the "7th World Congress on Sleep Apnea" in Helsinki on 2 July 2003. The complete Helsinki data is referred to at the aforementioned web link and can even be download at the bottom of this webpage as a PDF file. It remains the unanswered question until today why Vanderveken, Braem and Marklund had used for their cross-over study a non-validated development product from Tomed instead of the commercial one-part SomnoGuard with a proven track record of proven efficacy from clinical research.
Conclusion:
It is apparent that a few orthodontists and sleep dentists want to ban cheap prefabricated oral appliances from the market just to maintain in the future their extremely high profit margins for the fabrication of the custom-made oral appliances. Money rules the world, and these people fear to lose income by the cheap prefabricated oral appliances.
Because the examined non-validated prefabricated development device from Tomed abandoned in 2004 has not been and will never be available in any market and –on the other hand side - the
one-part custom-made appliance from Mrs. Marklund has some local market importance in Sweden only, we question at all the value of the publication cited by Reuters Health for the daily work in a doctors’ office.
Finally, we would be interested who has initiated the press release through Reuters Health.
Bensheim, 19 July 2009
Dr. Winfried Toussaint
Tomed Dr. Toussaint GmbH
Wiesenstr. 4
D - 64625 Bensheim
E-Mail:info@tomed.com
www.tomedcare.com