myTAP Oral Appliance Plus Mouth Shield to Reduce Periodontitis in Mouth-Breathers Who Snore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Respiration rate
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
- •Wear the oral appliance (OA) nightly as instructed for 12 weeks and with the mouth-shield (OA+) for the last 8 weeks
- •Complete brief surveys on sleep and related subjective experiences
- •Communicate with the clinical research coordinator regarding OA titration
- •Continue current medication and supplement use
- •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
排除标准
- •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
研究组 & 干预措施
OA plus Mouth Shield
Oral appliance therapy plus scaling and root planing on left or right of mouth
干预措施: Oral appliance therapy plus scaling and root planing on left or right of mouth (Device)
结局指标
主要结局
Respiration rate
时间窗: Baseline to 1, 2 and 3 months
Breaths per minute from NOX T3 sleep recording
Periodontal conditions
时间窗: Baseline to 3 months
Periodontal condition staged (I-IV) according to The American Academy of Periodontology (AAP) 2018 Guidelines.
Mouth breathing
时间窗: Baseline to 1, 2 and 3 months
Presence of mouth breathing from NOX T3 sleep recording
Respiratory event index (REI)
时间窗: Baseline to 1, 2 and 3 months
Number of apneas and hypopneas per hour of recording from NOX T3 sleep recording
次要结局
- 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)