COMPLETED

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

Conditions

Snoring Mouth Breathing Daytime Sleepiness Periodontitis obstructive sleep apnea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

myTAP Oral Appliance Plus Mouth Shield to Reduce Periodontitis in Mouth-Breathers Who Snore

Quick Facts

Study Start:2024-04-04

Study Completion:2025-01-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06797089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Emet D Schneiderman, PhD

PRINCIPAL_INVESTIGATOR

Texas A&M School of Dentistry

Study Locations (Sites)

Texas A&M University College of Dentistry

Dallas, Texas, 75246

United States

Collaborators and Investigators

Sponsor: Texas A&M University

Emet D Schneiderman, PhD, PRINCIPAL_INVESTIGATOR, Texas A&M School of Dentistry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04

Study Completion Date2025-01-23

Study Record Updates

Study Start Date2024-04-04

Study Completion Date2025-01-23

Terms related to this study

Keywords Provided by Researchers

Periodontitis
obstructive sleep apnea

Additional Relevant MeSH Terms

Snoring
Mouth Breathing
Daytime Sleepiness
Periodontitis