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Journal of Dental Sleep Medicine | Volume 4, Number 3 | July 10, 2017

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Journal of Dental Sleep Medicine | Volume 4, Number 3 | July 10, 2017 ISSN 2333-9756 Journal of Dental Sleep Medicine Official Publication of the American Academy of Dental Sleep Medicine | www.jdsm.org Volume 4, Number 3 In This Issue July 10, 2017 Pages 53–92 Safety and Efficacy of a Novel Oral Appliance in the Treatment of Obstructive Sleep Apnea Lavery, Szollosi, Czyniewski, Beer, McCloy, Hart The Efficacy of a Titrated Tongue Stabilizing Device on Obstructive Sleep Apnea and the Quality of Life: A Clinical Trial Study Protocol Okuno, Hamoda, Alshhrani, Fleetham, Ayas, Comey, Lowe, Pliska, Almeida A Case of Sleep-Breathing Changes Achieved Using the Andresen Activator in a Child With Maxillary Protrusion Medina, Ueda, Matsumura, Iwai, Sumi, Tanimoto Abstracts from the 26th Annual Meeting of the American Academy of Dental Sleep Medicine: Boston, MA, June 2–4, 2017 Official Publication of the American Academy of Dental Sleep Medicine Journal of Dental Sleep Medicine Volume 4, Number 3 | July 10, 2017 | Pages 53–92 Editor-in-Chief Editorial Board Leslie Dort, DDS Ghizlane Aarab, DDS, PhD Peter Cistulli, MD, PhD Deputy Editor Greg Essick, DDS, PhD Olivier Vanderveken, MD, PhD Bernard Fleury, MD Nelly Huynh, PhD Associate Editors Sam Kuna, MD B. Gail Demko, DMD Chris Lettieri, MD Gilles Lavigne, DMD, PhD Frank Lobbezoo, DDS, PhD Rose Sheats, DMD Marie Marklund, DDS, PhD Jean-Francois Masse, DMD, MSc Executive Director Antonio Romero-Garcia, DDS, PhD Jerome A. Barrett Kate Sutherland, BSc(Hons), PhD Satoru Tsuiki, DDS, PhD Journal of Dental Sleep Medicine (JDSM) (Online whole articles or any parts of works, figures or DISCLAIMER: The statements and opinions 2333-9756; Website: www.jdsm.org) is published tables published in JDSM must be obtained prior to contained in editorials and articles in this journal online quarterly on the 10th of January, April, publication. Permission for republication must be are solely those of the authors thereof and not of July and October by the American Academy of arranged through the Copyright Clearance Center, the American Academy of Dental Sleep Medicine, Dental Sleep Medicine, 2510 North Frontage Road, Inc., 222 Rosewood Drive, Danvers, MA 01923, or of its officers, regents, members or employees. Darien, IL 60561-1511, phone (630) 737-9705 and phone (978) 750-8400 or fax (978) 646-8600 or The Editor-in-Chief, the American Academy of fax (630) 737-9790. URL http://www.copyright.com. There are royalty Dental Sleep Medicine and its officers, regents, fees associated with such permissions. members and employees disclaim all responsibility ADVERTISING: Digital advertising is available on www.jdsm.org. Please contact the National Sales for any injury to persons or property resulting REPRINTS: For author reprints contact the Account Executive at [email protected] for from any ideas or products referred to in articles complete information. AADSM office. For commercial reprint orders contained in this journal. contact Cenveo Publisher Services, 4810 PERMISSION TO REPRODUCE: Written Williamsburg Road, #2, Hurlock, MD 21643 or © 2017 American Academy of Dental Sleep permission to reproduce, in print or electronically, [email protected]. Medicine Table of Contents Vol. 4, No. 3 EDITORIALS 55 Bias in Dental Sleep Medicine Research: Does it Matter to Clinicians? Leslie C. Dort ORIGINAL ARTICLES 57 Safety and Efficacy of a Novel Oral Appliance in the Treatment of Obstructive Sleep Apnea Damian Lavery, Irene Szollosi, Stefan Czyniewski, Fiona Beer, Karen McCloy, Christopher Hart 65 The Efficacy of a Titrated Tongue Stabilizing Device on Obstructive Sleep Apnea and the Quality of Life: A Clinical Trial Study Protocol Kentaro Okuno, Mona M. Hamoda, Waled M. Alshhrani, John A. Fleetham, Najib T. Ayas, Robert Comey, Alan A. Lowe, Benjamin T. Pliska, Fernanda R. Almeida CASE REPORTS 71 A Case of Sleep-Breathing Changes Achieved Using the Andresen Activator in a Child With Maxillary Protrusion Cynthia Concepción Medina, Hiroshi Ueda, Yu Matsumura, Koji Iwai, Keisuke Sumi, Kotaro Tanimoto 77 Using a Lingual Frenulum Depressor to Create an Airway in a Patient With Obstructive Sleep Apnea: A New Method Hiroshi Suzuki, Taiga Fukuda, Satoru Tsuiki, Yoshihiro Iwata, Mayuko Yoshimura, Tatsuo Sakamaki, Takashi Kaneda, Misao Kawara ABSTRACTS 81 26th Annual Meeting of the American Academy of Dental Sleep Medicine: Boston, MA, June 2–4, 2017 Instructions to authors are available online at www.jdsm.org JDSM EDITORIALS http://dx.doi.org/10.15331/jdsm.6676 Bias in Dental Sleep Medicine Research: Does it Matter to Clinicians? Leslie C. Dort, DDS, Diplomate, ABDSM, Editor-in-Chief Journal of Dental Sleep Medicine Calgary, Alberta, Canada Bias is “systematic error introduced into sampling or testing by questioned regarding outcomes or side effects depending on selecting or encouraging one outcome or answer over others.” 1 time since they occurred. Compared to a general clinic popula- Scientific studies are likely to be subject to various types of tion, subjects who know they are part of a study may be more bias that could limit the generalizability of the results. As clini- or less willing to use an oral appliance despite questionable cians, we need to be aware of potential sources of bias and how outcomes or significant side effects. they may be relevant to our specific patient populations. Keeping potential sources of bias in mind will help clini- Recognition and avoidance of bias in scientific research has cians interpret study results and consider the relevance of the been very well described.2,3 Some familiarity with sources of results to clinical practice. bias gives clinicians tools to critically evaluate the literature. Study designs of oral appliance outcomes, even randomized CITATION controlled trials, may have selection bias if the subjects included were limited to those: who have failed CPAP or are CPAP naïve, Dort LC. Bias in dental sleep medicine research: does it matter are of limited age range, are free of the common comorbidities to clinicians? Journal of Dental Sleep Medicine. 2017;4(3):55. associated with OSA, are compliant with therapy, or have been selected from limited clinical populations. Other designs risk REFERENCES bias when no control group is included. In studies reporting 1. Bias. Merriam-Webster website. https://www.merriam-webster.com/ on oral appliance outcomes with no control group, one cannot dictionary/bias. Accessed June 12, 2017. know—for example—how many subjects may have developed 2. Introduction to sources of bias in clinical trials. In: Higgins JPT, Green TMJ symptoms or dry mouth over the course of time when not S, eds. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. http://handbook.cochrane.org/chapter_8/8_4_ using oral appliances. introduction_to_sources_of_bias_in_clinical_trials.htm. Updated There may be systematic differences in the way patients were March 2011. Accessed June 12, 2017. treated that could introduce performance bias. It is very diffi- 3. Pannucci CJ, Wilkins EG. Identifying and avoiding bias in research. cult to blind investigators to what treatment subjects are getting Plast Reconstr Surg. 2010;126(2):619-625. and therefore investigators may unintentionally give different attention to one group over another. Some studies report on SUBMISSION & CORRESPONDENCE drop outs and use an intention to treat analysis. Others only INFORMATION include those who complete the protocol—a potential source of Submitted for publication June 12, 2017 attrition bias. Reporting bias may also be present depending on Accepted for publication June 12, 2017 the criteria used to determine which subjects’ data is included Address correspondence to: Leslie C. Dort, DDS, 1016-68th Ave SW, Suite 150, Calgary, AB T2V 4J2, Canada; Tel: (403) 202-4905; Fax: in the analysis. (403)202-0266; Email: [email protected] The use of questionnaires that have not been validated may introduce instrument bias. Non-validated questionnaires DISCLOSURE STATEMENT may have questions that inadvertently influence the answers Dr. Dort is Editor-in-Chief of the Journal of Dental Sleep Medicine. that patients give. Subjects are likely to have recall bias when Journal of Dental Sleep Medicine 55 Vol. 4, No. 3, 2017 JDSM ORIGINAL ARTICLES http://dx.doi.org/10.15331/jdsm.6678 Safety and Efficacy of a Novel Oral Appliance in the Treatment of Obstructive Sleep Apnea Damian Lavery, BDSc1; Irene Szollosi, PhD2; Stefan Czyniewski, BMedSci3; Fiona Beer, MSc3; Karen McCloy, BDSc, MS, MSMed; Christopher Hart, MPhil2 1National Dental Care, Brisbane, Queensland, Australia; 2Oventus Medical Pty Ltd., Brisbane, Queensland, Australia; 3Mobius Medical Pty Ltd., Sydney, New South Wales, Australia Study Objectives: To establish the safety and efficacy of a novel oral appliance (O2Vent Mono, Oventus Medical Pty Ltd., Brisbane, Australia), that incorporates a built-in enclosed airway, as an alternative treatment for obstructive sleep apnea (OSA). Methods: A prospective, single-arm, single-center study was performed. Participants had mild-moderate OSA or continuous positive airway pressure (CPAP) intolerant severe OSA. Ambulatory polysomnography (PSG), subjective snoring, and subjective nasal obstruction were assessed at baseline and following acclimatization with the device. Baseline mandibular protrusion was set at 50% and was increased to a maximum of 85% if required as determined by questionnaire and PSG. Participants with a ≥ 50% reduction in apnea-hypopnea index (AHI) were classified as responders. Compliance was recorded via a questionnaire. Results: In 29 participants (20 males, 9 females), mean ± standard deviation age = 49.3 ± 8.6 years, body mass index = 29.9 ± 6.1 kg/m2, AHI decreased from 41.8 ± 26.5 to 16.2 ± 15.4 (P < .001) or 62.5 ± 21.1%. Time spent below 90% oxygen saturation as assessed by pulse oximetry improved from 9.3 ± 12.7% to 2.2 ± 3.4% (P = .001). Seventeen participants (59%) had subjective nasal obstruction and 22 (75.9%) were classified as responders. Subgroup analysis between those with nasal obstruction (NO) and without nasal obstruction (NNO) revealed no significant difference in percentage of change in AHI from baseline (NO = 66.3 ± 18.1%, NNO = 57.0 ± 24.6%, P = .280) or response rate (NO = 76.5%, NNO = 75%, chi-square = 0.930).
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