IOA Preventing Occlusal Changes With MAD Use

NCT07103941 | Recruiting FDA Device

• 1 other identifier: 103755
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is evaluating two standard-of-care strategies used to prevent bite changes (occlusal changes) in patients treated with a Mandibular Advancement Device (MAD) for sleep-related breathing disorders such as obstructive sleep apnea (OSA). While MAD therapy is effective, it can lead to changes in how the teeth fit together, including the development of a posterior open bite. Participants in this study will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD, or performing daily jaw exercises. Both methods aim to reduce the risk of occlusal changes. The study will follow participants over a 3-month period and includes dental evaluations, 3D oral scans, and short daily surveys. Findings from this research may help guide best practices for preserving occlusion during MAD therapy.

Conditions

Sleep Related Breathing Disorder; Snoring; Open Bite; Obstructive Sleep Apnea (OSA); Occlusal Changes; Tooth Migration; Posterior Open Bite

Keywords

Interocclusal Aligner; Mandibular advancement Device; Posterior Open Bite; Occlusal Changes; Dental Changes; Protrusion; Sleep Appliance; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Number of participants enrolled in the study

  Recruitment will be measured by tracking the number of participants who agree to enroll in a randomized clinical trial comparing stretching exercises to the use of an interocclusal aligner (IOA).

  3 months

Secondary Outcomes (1)

• Change in posterior occlusal contact relationship from baseline

  Baseline, 4 weeks from baseline, 12 weeks from baseline

Other Outcomes (3)

• Change in axial inclination of maxillary incisors from baseline

  Baseline, 4 weeks from baseline, 12 weeks from baseline

• Change in axial inclination of mandibular incisors from baseline

  Baseline, 4 weeks from baseline, 12 weeks from baseline

• Change in Mesial shifting of mandibular molars from baseline

  Baseline, weeks from baseline, 12 weeks from baseline

Study Arms (2)

Interocclusal Aligner

ACTIVE COMPARATOR

Arm 1 (Interocclusal Aligner Group): "Morning Interocclusal Aligner to Maintain Occlusion" Participants in this arm will use a prefabricated thermoplastic device called the AM Aligner each morning immediately after removing their Mandibular Advancement Device (MAD). The aligner will be warmed and then gently bitten into for 2-5 minutes to help reposition the mandible and maintain the original occlusion. This approach is a standard-of-care method aimed at minimizing occlusal changes associated with MAD therapy.

Device: AM Aligner

Daily Jaw Exercises

ACTIVE COMPARATOR

Participants in this arm will be instructed to perform a standardized set of jaw exercises each morning after removing their MAD. The exercises include side-to-side jaw movements, backward pressure (such as the "thinker's pose"), and gentle simulated clenching.

Behavioral: Exercise

Interventions

AM Aligner DEVICE

Intervention Name: AM Aligner (Interocclusal Aligner) Type: Device Manufacturer: (AM Aligner; TAP Sleep Care, Texas, USA) Description: The AM Aligner is a prefabricated, commercially available thermoplastic appliance designed to help patients return their mandible to a normal resting position after nighttime use of a Mandibular Advancement Device (MAD). In this study, the aligner will be used each morning immediately after removing the MAD. The participant will bite into the warmed aligner for 2-5 minutes to promote realignment of the mandible and occlusion. This approach aims to minimize or prevent occlusal changes, including posterior open bite and anterior shift, associated with prolonged MAD therapy. This intervention is distinct from the alternative study arm, which uses a set of guided jaw exercises instead of a physical appliance to achieve the same goal. The AM Aligner used in this study is a standard-of-care option and is FDA-cleared for this use. It is not investigational.

Interocclusal Aligner

Exercise BEHAVIORAL

Participants in this arm will perform a standardized set of jaw exercises for 5 minutes each morning immediately after removing their Mandibular Advancement Device (MAD). The exercises are intended to assist in reestablishing the natural occlusal relationship following overnight mandibular advancement. This routine includes the following movements: Side-to-side jaw movements Backward pressure to the chin (similar to a "thinker's pose") Gentle simulated clenching The exercises are performed once daily and take approximately 2-3 minutes to complete. This approach represents a standard-of-care method for minimizing occlusal changes associated with MAD therapy.

Daily Jaw Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult participants (≥18 years)
• diagnosed with SRBD and prescribed Mandibular Advancement Device (MAD) therapy
• Participants will include patients with well restored natural dentition with all posterior teeth, excluding third molars, one missing premolar secondary to orthodontic treatment.

You may not qualify if:

• pervious orthognathic surgery
• anterior cross bite
• posterior cross bite
• existing open bite or implant supported restorations
• tooth mobility
• significant dental caries or periodontitis
• severe bruxism
• planned upcoming dental work including caps, crowns, implants, or braces
• inadequate mandibular protrusion
• severe micrognathia
• large tori
• significant claustrophobia
• significant nasal obstruction
• large oropharyngeal masses or large tonsils

Sponsors & Collaborators

• Isabel Moreno Hay: lead
• American Academy of Orofacial Pain: collaborator

Study Sites (1)

Orofacial Pain Center - University of Kentucky - Kentucky Clinic

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive; Open Bite; Tooth Migration

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Malocclusion; Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Isable Moreno Hay, MS, PhD

  University of Kentucky

  STUDY DIRECTOR

Central Study Contacts

Salma Habib, BDS

CONTACT

8593235500; skha265@uky.edu

Isabel Moreno Hay, MS, PhD

CONTACT

8593235500; orofacialpain@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment: Parallel Assignment Participants in this randomized clinical trial will be assigned to one of two parallel groups receiving standard-of-care interventions aimed at preventing occlusal changes during Mandibular Advancement Device (MAD) therapy for sleep-related breathing disorders. One group will use an interocclusal aligner (a morning repositioning device) after removing the MAD each morning. The other group will perform a daily set of jaw exercises designed to restore habitual occlusion. Each participant will remain in their assigned group for the duration of the 3-month study period, and no crossover between groups will occur. This parallel design allows for a direct comparison of the effectiveness of these two standard-of-care approaches in maintaining occlusal stability during MAD therapy.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: November 17, 2025
• Primary Completion: March 28, 2026
• Study Completion: April 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)