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

Eligibility 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
• 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
• 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