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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special oral device, the myTAP with a mouth shield, can improve gum disease symptoms in individuals who snore and breathe through their mouths. Researchers are evaluating whether using this device can also enhance sleep quality and reduce stress levels over 12 weeks. It is suitable for individuals with mild to moderate gum disease who struggle with mouth breathing and snoring, as confirmed by a home sleep test. Participants must wear the device nightly and attend regular dental appointments. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that may enhance oral health and overall well-being.

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 prior data suggests that this oral appliance therapy is safe for treating gum disease?

Research shows that the myTAP oral appliance with a mouth shield is easy to use. Studies have found that this device can improve gum health by reducing harmful bacteria, leading to healthier gums. It also aids breathing during sleep, benefiting those who snore or breathe through their mouths.

Studies have reported no serious side effects, suggesting that the oral appliance is safe for most people. It is intended for use alongside regular dental care, such as cleaning and treating the gums. Overall, evidence supports that this oral appliance is a safe option for managing gum disease and improving sleep-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Oral Appliance Therapy with MyTAP because it offers a non-invasive alternative to traditional gum disease treatments like scaling and root planing alone. This therapy includes a unique mouth shield that potentially enhances the effectiveness of root planing by targeting specific areas of the mouth. Unlike most treatments that focus solely on cleaning and scaling, the oral appliance may provide a novel mechanism to support gum health and promote healing. This approach could lead to improved outcomes and quicker relief for patients with gum disease.

What evidence suggests that the myTAP oral appliance with a mouth shield is effective for gum disease?

Research has shown that the myTAP oral device with a mouth shield, used by participants in this trial, can improve gum disease symptoms. Studies have found that it reduces mouth breathing and snoring, which can lead to gum issues. The device also decreases the growth of harmful bacteria in the mouth and reduces swelling. Users have reported better sleep and breathing, which can further benefit gum health. Overall, the myTAP device appears to be a promising tool for managing gum disease, especially for those who snore and breathe through their mouths. ^{1 4 5 6 7}

Who Is on the Research Team?

Emet D Schneiderman, PhD

Principal Investigator

Texas A&M School of Dentistry

Are You a Good Fit for This Trial?

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 will wear the oral appliance every night for 12 weeks and add a mouth-shield for the last 8 weeks.

Exclusion Criteria

Gingival probing depths > 5mm

My teeth are very loose.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12294119/

Effects of Oral Appliance Therapy with a Mouth Shield in ...

We theorized that optimizing the oral environment by reducing MB could lessen the overgrowth of periodontal pathogens and minimize inflammation ...

2.

tapintosleep.com

tapintosleep.com/new-study-reveals-positive-outcomes-of-mytap-oral-appliance-with-mouth-shield-in-managing-periodontitis-and-osa/

New Study Reveals Positive Outcomes of myTAP Oral ...

This article highlights the positive outcomes of the myTAP appliance, demonstrating its potential as an adjunctive therapy for improving ...

3.

researchgate.net

researchgate.net/publication/393176116_Effects_of_Oral_Appliance_Therapy_with_a_Mouth_Shield_in_Periodontitis_Patients_Who_Snore_A_Split-Mouth_Randomized_Controlled_Trial

(PDF) Effects of Oral Appliance Therapy with a Mouth ...

Conclusions: In mild–moderate periodontitis patients who snore, OAT+ reduces snoring, MB, and obstructive events, serving as an adjunct to SRP ...

4.

trial.medpath.com

trial.medpath.com/clinical-trial/42fc1341b44f72d3/nct06797089-mytap-oral-appliance-periodontitis-mouth-breathers

Does myTAP Oral Appliance Therapy Including a Mouth Shield ...

... (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 ...

5.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/25/NCT04876625/ICF_000.pdf

IRB2019-0421 Informed Consent Document

The purpose of this study is to evaluate whether the MyTAP + MS can improve sleep, breathing (respiration) during sleep, and reduce periodontal conditions. The ...

6.

mdpi.com

mdpi.com/2304-6767/13/7/292

Effects of Oral Appliance Therapy with a Mouth Shield in ...

This study evaluated whether OAT+, as an adjunct to SRP, improves periodontal health by reducing periodontal pathogens and facilitating upper airway patency.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40710137/

Effects of Oral Appliance Therapy with a Mouth Shield in ...

This study evaluated whether OAT+, as an adjunct to SRP, improves periodontal health by reducing periodontal pathogens and facilitating upper ...