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IOA Preventing Occlusal Changes With MAD Use

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 28, 2026 to Nov 28, 2026
    • Study completion date: Apr 30, 2026 to Dec 30, 2026
    v7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2025 to Nov 17, 2025
    • Site details revised
    v6
  3. Start date: Nov 3, 2025 to Dec 15, 2025
    • Primary completion date: Feb 28, 2026 to Mar 28, 2026
    • Study completion date: Mar 30, 2026 to Apr 30, 2026
    v5
  4. Start date: Sep 15, 2025 to Nov 3, 2025v4
  5. Start date: Aug 20, 2025 to Sep 15, 2025v3
  6. Primary completion date: Dec 30, 2025 to Feb 28, 2026
    • Study completion date: Jun 30, 2026 to Mar 30, 2026
    • Start date: Aug 18, 2025 to Aug 20, 2025
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07103941
Lead Sponsor Isabel Moreno Hay
Collaborators: American Academy of Orofacial Pain
Conditions
(from sponsor)		 Sleep Related Breathing Disorder, Snoring, Obstructive Sleep Apnea (OSA), Open Bite, Occlusal Changes, Tooth Migration, Posterior Open Bite
Related terms Open Bite, Sleep Apnea, Obstructive, Snoring, Tooth Migration
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov