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

NCT05420129 | Withdrawn

• 1 other identifier: HOUB2021/039
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Change in masticatory perfomance at 6 months

  The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation \[Qw (X) = 1 - 2E-(X/ X50)b\], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 6 months after treatment.

  Before treatment and 6 months after treatment

• Change in masticatory perfomance at 24 months

  The masticatory performance will be evaluated by assessing the degree of comminution of the silicon test food (Median particle size). The particles from five trials (10 g) will be dried and passed through a series of eight sieves (0.25, 0.425, 0.85, 2, 2.8, 3.15, 4, and 5.6 mm) while being shaken for 6 min. Once the cumulative weight distribution of the sieve contents will be determined, the median particle size (MPS) will be calculated for each subject using the Rosin-Rammler equation \[Qw (X) = 1 - 2E-(X/ X50)b\], where Qw (X) is the fraction of particles by weight with a diameter smaller than X; X50 (or MPS) is the size of a theoretical sieve through which 50% of the weight would pass; and b describes the breadth of the particle size distribution. Therefore, the lower the MPS, the better the masticatory performance. Participants will perform masticatory tests before and 24 months after treatment.

  Before treatment and 24 months after treatment

Secondary Outcomes (24)

• Change in masticatory mixing ability at 6 months

  Before treatment and 6 months after treatment

• Change in masticatory mixing ability at 24 months

  Before treatment and 24 months after treatment

• Change in the degree of satisfaction in masticatory function at 6 months

  Before treatment and 6 months after treatment

• Change in the degree of satisfaction in masticatory function at 24 months

  Before treatment and 24 months after treatment

• Change in chewing ability at 6 months

  Before treatment and 6 months after treatment

Study Arms (2)

MAD. Mandibular advancement Device

Patients diagnosed with Obstructive Sleep Apnea and treated with MAD

Device: MAD Therapy

CPAP. Continuous Possitive Airway Pressure

Patients diagnosed with Obstructive Sleep Apnea and treated with CPAP

Device: CPAP Therapy

Interventions

MAD Therapy DEVICE

Participants will be treated with a Mandibular Advancement Device therapy

MAD. Mandibular advancement Device

CPAP Therapy DEVICE

Participants will be treated with a Continuous Positive Airway Pressure therapy

CPAP. Continuous Possitive Airway Pressure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with sleep apnea and treated with CPAP or MAD

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital Odontologic Universitat de Barcelona

L'Hospitalet de Llobregat, 08907, Spain

Location

Related Publications (6)

• 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.

  PMID: 31270888 BACKGROUND

• 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.

  PMID: 26111925 BACKGROUND

• 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.

  PMID: 29240971 BACKGROUND

• 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.

  PMID: 29241026 BACKGROUND

• 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.

  PMID: 19852636 BACKGROUND

• 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.

  PMID: 31863188 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Eva Willaert, DDS PhD

  University of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 15, 2022
• Study Start: November 30, 2023
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2032
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)