Does myTAP Oral Appliance Therapy Including a Mouth Shield Lessen Periodontitis in Mouth-Breathers Who Snore?

Launched by TEXAS A&M UNIVERSITY · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special oral device called the myTAP oral appliance, which includes a mouth shield, can help reduce gum disease (periodontitis) in adults who snore and breathe through their mouths. Researchers believe that mouth breathing and snoring might make gum disease worse, and they want to see if using this device over 12 weeks can improve both sleep quality and gum health. Participants will also receive thorough periodontal care during the study.

To be eligible for this trial, you need to be an adult between 18 and 85 years old, and you must have been confirmed to snore and breathe through your mouth, along with experiencing daytime sleepiness. You should also have mild to moderate gum disease and at least eight natural teeth to support the oral appliance. If you join the study, you will wear the oral device at night, complete surveys about your sleep, and attend regular appointments for dental care. This trial will help us understand more about the connection between sleep, breathing, and gum health, which could lead to better treatments in the future.

Gender

ALL

Eligibility 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