Oral Appliance Therapy for Gum Disease

(OAplusPerio Trial)

Overseen By Emet D Schneiderman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Disqualifiers: Severe xerostomia, Morbid obesity, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

27 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires participants to continue their current medication and supplement use.

What is the purpose of this trial?

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.

Research Team

Emet D Schneiderman, PhD

Principal Investigator

Texas A&M School of Dentistry

Eligibility Criteria

Adults with mild to moderate gum disease who snore and breathe through their mouths during sleep. Participants should not have other health conditions that could affect the trial's results.

Inclusion Criteria

Central and mixed apnea index < 5 events/hour

Able to speak, read, and comprehend English fluently

I can provide a saliva sample.

Exclusion Criteria

Gingival probing depths > 5mm

Severe psychiatric and neurological disorders such as current substance abuse (including alcohol, nicotine); major depression and psychotic disorder; seizure disorder

My teeth are very loose.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Initial Periodontal Treatment

Initial periodontal deep cleaning on one side of the mouth

1 week

1 visit (in-person)

OA Therapy

Participants use the oral appliance (OA) for 4 weeks

4 weeks

2 visits (in-person)

OA+ Therapy

Participants use the oral appliance with mouth shield (OA+) for 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in periodontal conditions and sleep respiration

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• MyTAP Oral Appliance Therapy with Mouth Shield

Trial Overview The study is testing if a special oral appliance with a mouth shield, used alongside regular dental cleaning treatments, can improve gum health in people who snore and mouth-breathe over 12 weeks.

Participant Groups

Group I: OA plus Mouth Shield Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+