Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breathers Who Snore?
Completed · Not applicable
Conditions studied: Snoring, Mouth Breathing, Daytime Sleepiness, Periodontitis
In brief
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.
Key facts
- Study ID
- NCT06797089
- Run by
- Texas A&M University
- People needed
- 43
- Starts
- 2024-04-04
- Expected to finish
- 2025-01-23
- Last updated by the study team
- 2025-09-30
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- At least 12 years of education
- Ability to apply and remove home sleep recorder
- Willingness to...
- Share PHI, medication list, current and past medical and dental information with research team members as needed
- Follow all oral hygiene instructions and attend all appointments (periodontal and otherwise) as stipulated by the protocol
- Allow the collection of plaque and waste materials from periodontal procedures and allow them to be evaluated for bacterial DNA (not human DNA)
- Provide saliva samples (spit into tube)
- Wear the oral appliance (OA) nightly as instructed for 12 weeks and with the mouth-shield (OA+) for the last 8 weeks
- Complete brief surveys on sleep and related subjective experiences
- Communicate with the clinical research coordinator regarding OA titration
- Continue current medication and supplement use
- Wait till the end of 12-week experimental period to complete periodontal therapy; this will include scaling, root planing of untreated side of dentition as well as redoing the treated side
You may not qualify if…
- Gingival probing depths > 5mm
- Tooth mobility score greater than 2
- Severe xerostomia
- 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
- Diagnosis of severe periodontitis
- Morphological airway abnormalities (malformations of throat; e.g., a very small airway due to a condition such as severe micrognathia or Pierre Robin Syndrome)
- Restrictions in jaw opening (difficult opening mouth widely) < 30 mm
- Pre-existing difficulty swallowing; throat or neck related health issues;
- Previous major surgery to throat and surrounding area such as UPPP (uvulopalatopharyngoplasty)
- Intellectual disability that would prevent giving informed consent
- Serious hormonal disease (endocrine dysfunction such as Addison's disease, Cushing's disease, hyperthyroidism); Diabetes and osteoporosis are OK)
- Pregnant, breast feeding or intent to become pregnant during the study
Where it is running
- Texas A&M University College of Dentistry — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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