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Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breathers Who Snore?

NCT06797089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-09-30

No results posted yet for this study

Summary

Mouth breathing, snoring and poor sleep can contribute to and worsen periodontitis (gum disease). The purpose of this study is to test whether the myTAP oral appliance with a mouth shield (OA+) can lessen periodontal symptoms in those with these conditions over a 12 week period. In addition to testing sleep respiration and quality, it will also evaluate periodontal pathogens and systemic stress in subjects treated with OA+. This split-mouth clinical trial will include adults with mild to moderate periodontist who snore and mouth breath. All will receive comprehensive periodontal care in addition to OA+ therapy.

Conditions

  • Snoring
  • Mouth Breathing
  • Daytime Sleepiness
  • Periodontitis

Interventions

DEVICE

Oral appliance therapy plus scaling and root planing on left or right of mouth

This device opens the upper airway by bringing the mandible forward to improve breathing during sleep. The mouth shield minimizes mouth breathing to optimize salivary function. Scaling and root planing (deep cleaning of all teeth requiring it).

Sponsors & Collaborators

Principal Investigators

  • Emet D Schneiderman, PhD · Texas A&M School of Dentistry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2025-01-23
Completion
2025-01-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797089 on ClinicalTrials.gov