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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Able to speak, read, and comprehend English fluently
Exclusion criteria
. 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