Clinical trial NCT05420129: Side Effects of the Mandibular Advancement Device for Apnea Treatment on Dental Occlusion and Masticatory Function
Official title: Side Effects of the Use of the Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea on Dental Occlusion and Masticatory Function
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with sleep apnea and treated with CPAP or MAD

Brief summary: This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment.

52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with MAD and 26 participants will be treated with continuous positive airway pressure (CPAP) as a control group.

Participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. Masticatory satisfaction perceived by the participants will be evaluated by questionnaires. Occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and T-Scan registrations and 3D digital models obtained with intraoral scan. Data collection will be performed before treatment with MAD or CPAP, and at 3, 6, 12, and 24 months from the start of treatment.

Detailed description: This prospective observational non-randomized clinical study aims to assess the effect of use MAD on masticatory performance. 52 subjects diagnosed with OSA will participate in this study divided into two different groups: 26 treated with MAD and 26 treated with CPAP. Data collection will be carried out before the start of treatment of the two modalities and at 3, 6, 12 and 24 months after starting the treatment. The intervention of the study will be based on execute chewing tests to evaluate masticatory performance from artificial food. Other aspects of matsticatory function would be also explored like subjective masticatory performance and jaw function limitation, dental position and occlusion, bite force or dental mobility. Artificial food tests will evaluate masticatory performance in comminute and mixing ability to determine the degree of reduction in masticatory performance produced by the use of MAD after 3 months of treatment. The main variable to be studied will be the median particle size of silicone tablets from Optozeta's test. This test is based on chewing 2 grams of silicone tablets inside a latex bag in order to evaluate their degree of comminution. The greater of grinded silicone, the greater of chewing performance. Another masticatory performance test will also be carried out is evaluation subject's mixing capacity with a two-colour chewing gum test. Degree of mixing of two colours of the gum will be checked after 40 chewing cycles. The more uniformity of the colour obtained, the more mixing ability the subject will demonstrate. A CPAP group control will be used, which will additionally allows us to know if this treatment has effects on dental position, occlusion and masticatory performance.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with OSA by polisomnography (IAH\>15).

Exclusion Criteria:

* Be treated with MAD or CPAP during more than 3 months in the lasts 5 years.

Primary outcomes:
measure: Change in masticatory perfomance at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in masticatory perfomance at 24 months
timeFrame: Before treatment and 24 months after treatment
Secondary outcomes:
measure: Change in masticatory mixing ability at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in masticatory mixing ability at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in the degree of satisfaction in masticatory function at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in the degree of satisfaction in masticatory function at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in chewing ability at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in chewing ability at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in jaw functional limitation.at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in jaw functional limitation.at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in masticatory rhythm at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in masticatory rhythm at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in masticatory laterality at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in masticatory laterality at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in masticatory side-switch frequency at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in masticatory side-switch frequency at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in overjet at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in overjet at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in overbite at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in overbite at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in occlusal contact area at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in occlusal contact area at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in bite force at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in bite force at 24 months
timeFrame: Before treatment and 24 months after treatment
measure: Change in dental mobility at 6 months
timeFrame: Before treatment and 6 months after treatment
measure: Change in dental mobility at 24 months
timeFrame: Before treatment and 24 months after treatment
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Odontologic Universitat de Barcelona
Study officials:
affiliation: University of Barcelona
name: Eva Willaert, DDS PhD
role: STUDY_DIRECTOR
References:
citation: Ayuso-Montero R, Mariano-Hernandez Y, Khoury-Ribas L, Rovira-Lastra B, Willaert E, Martinez-Gomis J. Reliability and Validity of T-scan and 3D Intraoral Scanning for Measuring the Occlusal Contact Area. J Prosthodont. 2020 Jan;29(1):19-25. doi: 10.1111/jopr.13096. Epub 2019 Jul 21.
citation: Schimmel M, Christou P, Miyazaki H, Halazonetis D, Herrmann FR, Muller F. A novel colourimetric technique to assess chewing function using two-coloured specimens: Validation and application. J Dent. 2015 Aug;43(8):955-64. doi: 10.1016/j.jdent.2015.06.003. Epub 2015 Jun 22.
citation: Riera-Punet N, Martinez-Gomis J, Willaert E, Povedano M, Peraire M. Functional limitation of the masticatory system in patients with bulbar involvement in amyotrophic lateral sclerosis. J Oral Rehabil. 2018 Mar;45(3):204-210. doi: 10.1111/joor.12597. Epub 2017 Dec 30.
citation: Khoury-Ribas L, Ayuso-Montero R, Rovira-Lastra B, Peraire M, Martinez-Gomis J. Reliability of a new test food to assess masticatory function. Arch Oral Biol. 2018 Mar;87:1-6. doi: 10.1016/j.archoralbio.2017.12.006. Epub 2017 Dec 9.
citation: Martinez-Gomis J, Willaert E, Nogues L, Pascual M, Somoza M, Monasterio C. Five years of sleep apnea treatment with a mandibular advancement device. Side effects and technical complications. Angle Orthod. 2010 Jan;80(1):30-6. doi: 10.2319/030309-122.1.
citation: Uniken Venema JAM, Doff MHJ, Joffe-Sokolova DS, Wijkstra PJ, van der Hoeven JH, Stegenga B, Hoekema A. Dental side effects of long-term obstructive sleep apnea therapy: a 10-year follow-up study. Clin Oral Investig. 2020 Sep;24(9):3069-3076. doi: 10.1007/s00784-019-03175-6. Epub 2019 Dec 20.