An interventional study of Oral appliance therapy plus scaling and root planing on left or right of mouth in Snoring, Mouth Breathing and Daytime Sleepiness, sponsored by Texas A&M University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Texas A&M University · Not applicable, Interventional, and Treatment
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.
BACKGROUND \& MOTIVATION
The keystone pathogen in chronic periodontitis, Porphyromonas gingivalis has been identified as a significant risk factor in the pathogenesis for developing Alzheimer's disease (AD) and was recently identified in the brains AD patients. Primary snoring, mouth breathing (MB) and obstructive sleep apnea (OSA) are also frequent findings in AD patients. MB impairs oral health, reduces quantity and quality of saliva, and increases dry mouth, risk of developing dental caries, gingival inflammation, bad breath and dry lips. This proposal aims to fill the information gap on the effects of oral appliance therapy on periodontitis by following up on participants in our previous randomized clinical trial.
INNOVATION
Periodontal disease affects about half of all US adults. Patients with periodontal inflammation, moderate to heavy bleeding of the gums with deep pockets demonstrate poor gum healing and persistent bacterial infection. Typically, patients are instructed to use over-the-counter oral rinse solutions twice a day to improve their periodontitis. OA used during sleep is expected to provide longer therapeutic exposure of saliva to teeth and gums in addition to optimizing upper airway stability, snoring and OSA attenuation, and MB inhibition.
DESCRIPTION
Two previous studies by the Sleep Research Program at Texas A\&M University School of Dentistry have shown that with mandibular advancement oral appliance (OA) therapy, significant improvements in breathing during sleep and in cognition occur in those who have obstructive sleep apnea and snore. A third study suggests that improvements in the oral environment and in periodontal disease are possible with a combined therapy (OA+) that includes a mandibular advancement oral appliance with a mouth-shield (MS). The current study is intended to evaluate OA+ efficacy in attenuating mouth breathing and periodontal symptoms in those with these conditions over 12 weeks. In addition to testing sleep respiration and quality, it will also evaluate periodontal pathogens and systemic stress (assay using ELISA assay) in subjects treated with OA+. The clinical trial will include 27 adults with mild to moderate periodontist who snore and mouth breath. A randomized split-mouth design cohort design will be used to separate out the combined and independent effects of OA+ therapy and periodontal therapy. After an initial periodontal deep cleaning on one side of the mouth, all subjects will begin using an OA for 4 weeks. At 4 weeks, they will all begin using OA+ for the next 8 weeks. Changes from baseline to 4-, 8- and 12- weeks will be evaluated and compared on the periodontally treated and control sides. Their sleep respiration will be monitored using the NOX T3 sleep recorder for 1-night (pre-screening), and then 2 consecutive nights at baseline (T0) 4- 8- and 12 weeks Full periodontal evaluations will be performed at baseline, 4- 8- and 12 weeks. Plaque samples will be taken on both sides of the mouth at baseline and 12 weeks to evaluate periodontal and systemic pathogens. At the completion of the study, all subjects will receive a full mouth deep cleaning to optimize their periodontal health. As compensation, there will be no costs to participants for either the periodontal evaluation and treatment, or the OA+ therapy to improve their sleep. The myTAP OA, fabricated by AMI Inc. Dallas, TX will be the primary intervention. It is FDA cleared, low-cost, and is unique in that it includes a mouth-shield and is efficiently fitted chairside (no laboratory work or expenses involved). This dental care provided to participants at no cost to them would be approximately $750 at this dental school and up to $4500 in private practice.
Primary outcome variables: periodontal assessment, apnea hypopnea index, mouth breathing, respiration rate. Secondarily, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans and cortisol will be assayed from plaque and saliva samples respectively. The projected timeline for the project is 12 months. Each subject will participate for 13-16 weeks.
The primary intervention, the myTAP oral appliance, and the sleep recorder , the NOX T3, are FDA cleared devices and have been in widespread use for many years.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's enrollment of 43 is close to the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ability to apply and remove home sleep recorder
Willingness to...
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Periodontal conditions
Periodontal condition staged (I-IV) according to The American Academy of Periodontology (AAP) 2018 Guidelines.
Time frame: Baseline to 3 months
Mouth breathing
Presence of mouth breathing from NOX T3 sleep recording
Time frame: 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
Time frame: Baseline to 1, 2 and 3 months
Respiration rate
Breaths per minute from NOX T3 sleep recording
Time frame: Baseline to 1, 2 and 3 months
Periodontal and systemic bacteria from plaque samples
Bacterial level in genome copies/milliliter in log10 values of 11 species
Time frame: Baseline to 3 months
Mean oxygen desaturation, SaO2
Mean percentage of oxygen saturation values obtained using pulse oximetry.
Time frame: Baseline to 1, 2 and 3 months
Salivary cortisol level
Nanograms of cortisol per milliliter of saliva
Time frame: Baseline to 3 months
Ran from Apr 2024 to primary completion in Jan 2025, 9 months.
Of 33 non-industry interventional studies with no phase under Snoring, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 31. This study's 9 months is below that.
Counting every sponsor, half of 45 studies reached it within 20 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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