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

NCT06797089 | Completed FDA Device

• 1 other identifier: IRB2022-1450
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Snoring; Mouth Breathing; Daytime Sleepiness; Periodontitis

Keywords

Periodontitis; obstructive sleep apnea

Outcome Measures

Primary Outcomes (4)

• Periodontal conditions

  Periodontal condition staged (I-IV) according to The American Academy of Periodontology (AAP) 2018 Guidelines.

  Baseline to 3 months

• Mouth breathing

  Presence of mouth breathing from NOX T3 sleep recording

  Baseline to 1, 2 and 3 months

• Respiratory event index (REI)

  Number of apneas and hypopneas per hour of recording from NOX T3 sleep recording

  Baseline to 1, 2 and 3 months

• Respiration rate

  Breaths per minute from NOX T3 sleep recording

  Baseline to 1, 2 and 3 months

Secondary Outcomes (3)

• Periodontal and systemic bacteria from plaque samples

  Baseline to 3 months

• Mean oxygen desaturation, SaO2

  Baseline to 1, 2 and 3 months

• Salivary cortisol level

  Baseline to 3 months

Study Arms (1)

OA plus Mouth Shield

EXPERIMENTAL

Oral appliance therapy plus scaling and root planing on left or right of mouth

Device: Oral appliance therapy plus scaling and root planing on left or right of mouth

Interventions

Oral appliance therapy plus scaling and root planing on left or right of mouth DEVICE

This device opens the upper airway by bringing the mandible forward to improve breathing during sleep. The mouth shield minimizes mouth breathing to optimize salivary function. Scaling and root planing (deep cleaning of all teeth requiring it).

Also known as: myTAP mandibular advancement device plus mouth shield

OA plus Mouth Shield

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mouth breathing and snoring confirmed by home sleep test (NOX T3; ≥4 snores/hour) and complaints of excessive daytime sleepiness
• Seeking treatment for periodontitis (stage 1 or 2 as confirmed by full periodontal examination at Visit 1 or 2)
• Adults 18-85 years old
• Stable medical condition (e.g., diabetes or hypertension properly managed)
• At least 8 natural maxillary teeth to support the oral appliance
• Mallampati score from I to III; Palatine tonsils - grade 0, 1, or 2
• Central and mixed apnea index \< 5 events/hour
• Able to speak, read, and comprehend English fluently
• At least 12 years of education
• Ability to apply and remove home sleep recorder
• Willingness to...
• Share PHI, medication list, current and past medical and dental information with research team members as needed
• Follow all oral hygiene instructions and attend all appointments (periodontal and otherwise) as stipulated by the protocol
• Allow the collection of plaque and waste materials from periodontal procedures and allow them to be evaluated for bacterial DNA (not human DNA)
• Provide saliva samples (spit into tube)

You may not qualify if:

• Gingival probing depths \> 5mm
• Tooth mobility score greater than 2
• Severe xerostomia
• 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),
• Severe psychiatric and neurological disorders such as current substance abuse (including alcohol, nicotine); major depression and psychotic disorder; seizure disorder
• Morbid obesity (Body Mass Index: BMI ≥35)
• Active temporomandibular joint disorder (TMD) or jaw muscle pain; persistent history of TMD
• Diagnosis of severe periodontitis
• Morphological airway abnormalities (malformations of throat; e.g., a very small airway due to a condition such as severe micrognathia or Pierre Robin Syndrome)
• Restrictions in jaw opening (difficult opening mouth widely) \< 30 mm
• Pre-existing difficulty swallowing; throat or neck related health issues;
• Previous major surgery to throat and surrounding area such as UPPP (uvulopalatopharyngoplasty)
• Intellectual disability that would prevent giving informed consent
• Serious hormonal disease (endocrine dysfunction such as Addison's disease, Cushing's disease, hyperthyroidism); Diabetes and osteoporosis are OK)
• Pregnant, breast feeding or intent to become pregnant during the study

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Snoring; Mouth Breathing; Disorders of Excessive Somnolence; Periodontitis; Sleep Apnea, Obstructive

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Sleep Apnea Syndromes; Apnea

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Emet D Schneiderman, PhD

  Texas A&M School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The periodontist performing the initial one-sided SRP does not know which side has been assigned to receive the therapy until the actual time of performance (blinding of investigator). The investigator is given an envelope with the side assignment at this time. Final assessment of periodontitis measures will be performed by a periodontist who will not be told which side of the mouth received the SRP therapy initially. Similarly, the investigator evaluating the oral bacteria samples will be blinded as to which side received SRP (blinding of outcomes assessors). The blinding pertains to the split-mouth design, not assignment of patients to treatments.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Oral Appliance plus mouth shield is applied to all subjects. Initially, all subjects will receive adjunctive scaling and root planing (SRP) on one side of the mouth (randomly assigned).

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: April 4, 2024
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (1)