Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breather… (NCT06797089) | Clinical Trial Compass
CompletedNot Applicable
Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breathers Who Snore?
United States43 participantsStarted 2024-04-04
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Mouth breathing and snoring confirmed by home sleep test (NOX T3; ≥4 snores/hour) and complaints of excessive daytime sleepiness
✓. Seeking treatment for periodontitis (stage 1 or 2 as confirmed by full periodontal examination at Visit 1 or 2)
✓. Adults 18-85 years old
✓. Stable medical condition (e.g., diabetes or hypertension properly managed)
✓. At least 8 natural maxillary teeth to support the oral appliance
✓. Mallampati score from I to III; Palatine tonsils - grade 0, 1, or 2
✓. Central and mixed apnea index \< 5 events/hour
✓. Able to speak, read, and comprehend English fluently
✕. Severe medical illness such as symptomatic chronic obstructive pulmonary disease, renal failure, symptomatic coronary or cerebral vascular disease, cardiac dysrhythmia (i.e., atrial fibrillation); pacemaker; cardiopulmonary dysfunction (i.e., chronic heart failure),
✕. Severe psychiatric and neurological disorders such as current substance abuse (including alcohol, nicotine); major depression and psychotic disorder; seizure disorder
✕. Morbid obesity (Body Mass Index: BMI ≥35)
✕. Active temporomandibular joint disorder (TMD) or jaw muscle pain; persistent history of TMD