Using a mouth appliance to reduce gum disease in snorers who breathe through their mouths
myTAP Oral Appliance Plus Mouth Shield to Reduce Periodontitis in Mouth-Breathers Who Snore
This study is testing if a special mouth appliance can help reduce gum disease and improve sleep quality in adults who snore and breathe through their mouths.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Texas A&M University Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06797089 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the myTAP oral appliance with a mouth shield in reducing periodontal symptoms in adults who snore and breathe through their mouths. Over a 12-week period, participants will receive comprehensive periodontal care alongside the oral appliance therapy. The study will assess improvements in sleep quality, respiratory function, and the presence of periodontal pathogens. It aims to address the relationship between oral health and sleep-related breathing disorders.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 who are mouth breathers, snorers, and seeking treatment for mild to moderate periodontitis.
Not a fit: Patients with severe periodontitis or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve oral health and reduce symptoms of periodontitis in affected patients.
How similar studies have performed: Previous studies have shown promising results with oral appliance therapy for improving sleep-related conditions and oral health, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- Texas A&M University College of Dentistry — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Emet D Schneiderman, PhD — Texas A&M School of Dentistry
- Study coordinator: Emet D Schneiderman, PhD
- Email: eschneiderman@tamu.edu
- Phone: 214-828-8377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.