Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a snore device also fight gum disease?

NCT ID NCT06797089

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a special oral appliance called myTAP, combined with a mouth shield and deep dental cleaning, can reduce gum disease in people who snore and breathe through their mouth. 43 adults with mild to moderate gum disease completed the 12-week trial. The device aims to improve breathing during sleep and reduce mouth breathing, which may help gum health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
myTAP oral appliance with mouth shield
What this could lead to
If it works, this could point toward a non-drug way to manage gum disease in people who mouth-breathe and snore.
What could go wrong
This is a small, early-stage study with only 43 people. Results may not apply to everyone, and the device may not improve gum health for all users.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

43 people

The number who actually took part.

Started

Apr 2024

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Mouth breathing and snoring confirmed by home sleep test (NOX T3; ≥4 snores/hour) and complaints of excessive daytime sleepiness 2. Seeking treatment for periodontitis (stage 1 or 2 as confirmed by full periodontal examination at Visit 1 or 2) 3. Adults 18-85 years old 4. Stable medical condition (e.g., diabetes or hypertension properly managed) 5. At least 8 natural maxillary teeth to support the oral appliance 6. Mallampati score from I to III; Palatine tonsils - grade 0, 1, or 2 7. Central and mixed apnea index \< 5 events/hour 8. Able to speak, read, and comprehend English fluently 9. At least 12 years of education 10. Ability to apply and remove home sleep recorder Willingness to... 11. Share PHI, medication list, current and past medical and dental information with research team members as needed 12. Follow all oral hygiene instructions and attend all appointments (periodontal and otherwise) as stipulated by the protocol 13. Allow the collection of plaque and waste materials from periodontal procedures and allow them to be evaluated for bacterial DNA (not human DNA) 14. Provide saliva samples (spit into tube) 15. Wear the oral appliance (OA) nightly as instructed for 12 weeks and with the mouth-shield (OA+) for the last 8 weeks 16. Complete brief surveys on sleep and related subjective experiences 17. Communicate with the clinical research coordinator regarding OA titration 18. Continue current medication and supplement use 19. 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 Exclusion Criteria 1. Gingival probing depths \> 5mm 2. Tooth mobility score greater than 2 3. Severe xerostomia 4. 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), 5. Severe psychiatric and neurological disorders such as current substance abuse (including alcohol, nicotine); major depression and psychotic disorder; seizure disorder 6. Morbid obesity (Body Mass Index: BMI ≥35) 7. Active temporomandibular joint disorder (TMD) or jaw muscle pain; persistent history of TMD 8. Diagnosis of severe periodontitis 9. Morphological airway abnormalities (malformations of throat; e.g., a very small airway due to a condition such as severe micrognathia or Pierre Robin Syndrome) 10. Restrictions in jaw opening (difficult opening mouth widely) \< 30 mm 11. Pre-existing difficulty swallowing; throat or neck related health issues; 12. Previous major surgery to throat and surrounding area such as UPPP (uvulopalatopharyngoplasty) 13. Intellectual disability that would prevent giving informed consent 14. Serious hormonal disease (endocrine dysfunction such as Addison's disease, Cushing's disease, hyperthyroidism); Diabetes and osteoporosis are OK) 15. Pregnant, breast feeding or intent to become pregnant during the study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Daytime sleepiness are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence Mouth Breathing obstructive sleep apnea syndrome periodontitis Snoring

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Texas A&M University College of Dentistry

    Dallas, Texas, 75246, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.