Side Effects of the Mandibular Advancement Device for Apnea Treatment on Dental Occlusion and Masticatory Function

NCT ID: NCT05420129

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2032-05-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MAD. Mandibular advancement Device

Patients diagnosed with Obstructive Sleep Apnea and treated with MAD

MAD Therapy

Intervention Type: DEVICE

Participants will be treated with a Mandibular Advancement Device therapy

CPAP. Continuous Possitive Airway Pressure

Patients diagnosed with Obstructive Sleep Apnea and treated with CPAP

CPAP Therapy

Intervention Type: DEVICE

Participants will be treated with a Continuous Positive Airway Pressure therapy

Interventions

MAD Therapy

Participants will be treated with a Mandibular Advancement Device therapy

Intervention Type: DEVICE

CPAP Therapy

Participants will be treated with a Continuous Positive Airway Pressure therapy

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Jordi Martinez-Gomis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Willaert, DDS PhD

Role: STUDY_DIRECTOR

University of Barcelona

Locations

Hospital Odontologic Universitat de Barcelona

L'Hospitalet de Llobregat, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 31270888 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26111925 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29240971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29241026 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19852636 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31863188 (View on PubMed)

Other Identifiers

HOUB2021/039

Identifier Type: -

Identifier Source: org_study_id