NCT05282615已完成不适用
A Randomized, Controlled, Proof of Concept Trial of the Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage III periodontitis. After eligibility determination, subjects will be randomized to the following groups:
- Group 1: Full mouth periodontal debridement + Emanate Tray (treatment group)
- Group 2: Full mouth periodontal debridement alone (control group)
Patients will be evaluated at Baseline and on Days 14, 28, and 56 for primary endpoint and at baseline and on day 56 post-treatment for secondary (efficacy) endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed, written informed consent prior to participation in any study-related procedures.
- •Good general health as evidenced by medical history.
- •At least 18 years of age at time of informed consent signature.
- •Minimum of 18 teeth, excluding third molars.
- •Generalized Stage II-III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥4 mm and ≤7mm, distributed between mandible and maxilla, with at least 2 qualifying interproximal sites in each arch. Localized and not more than ≤6 sites with a PD of 8 mm is acceptable as long as the tooth with 8 mm pocket depth is not clinically diagnosed as hopeless tooth with suppuration or mobility Grade 3 or greater
- •Having ≥40 percent of sites with bleeding upon probing as a sign of inflammation
- •Willing to use prescribed oral hygiene procedures and products
- •Willingness to maintain their routine dental care
- •Willing to abstain from chewing gums, mouth rinses and whitening products for the study duration.
- •Ability and willingness to attend all study visits and comply with all study visits and all study procedures and requirements.
- •For women with reproductive potential, willingness to use highly effective contraception (e.g., licensed hormonal contraception, intrauterine device, or vasectomy in partner).
排除标准
- •Presence of orthodontic appliances (anterior fixed retainers are allowed as long as the qualifying teeth are not involved).
- •A soft or hard tissue tumor of the oral cavity.
- •Patients with heavy subgingival calculus.
- •Any dental condition that requires immediate treatment, such as carious lesions.
- •Dental implants will be excluded from study, but the patients will not be excluded if they are otherwise eligible
- •Periodontal treatment including SRP within the prior 6 months of enrollment.
- •Participation in any other clinical study within 30 days of screening or during the study.
- •Pregnancy or lactation.
- •Patients that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol, or ethylene vinyl acetate
- •Antibiotic therapy within the last month (30 days)
- •Current smoking (cigarette, cigar, e-cigarette, or marijuana) within 1 year of enrollment
- •Patients that have a history of testing positive for SARS-CoV-2 per patient's report (within last 10 days) or currently having lingering/long-term COVID symptoms.
- •Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti inflammatory drugs, steroids). Low-dose aspirin, 81-162 mg is allowed.
- •Immunocompromised subjects (i.e., subjects with AIDS, pulmonary fibrosis, undergoing chemotherapy or radiation treatment etc.).
- •Diabetes Mellitus defined as a HbA1c > 6.5 per laboratory test results
- •Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, and total bilirubin) levels equal to > 1.5 times the upper limit of normal
- •Serum creatinine levels equal to > 2 times the upper limit of normal
- •Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as nifedipine, phenytoin (Dilantin), or anticoagulant medications (e.g., warfarin [Coumadin] etc.).
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 56 days
The number and percentage of subjects who experience at least 1 treatment-emergent AE (TEAE) and the number and percentage of subjects who experience at least 1 TEAE within each specific system organ class (SOC) and preferred term (PT).
次要结局
- To evaluate the primary efficacy-effect of Emanate Tray on bleeding and probing (BOP)(56 days)
- To evaluate changes in plaque index (PI)(56 days)
- To evaluate the effect of Emanate Tray on pocket depth (PD) reduction(56 days)
- To evaluate the effect of Emanate Tray on clinical attachment level (CAL)(56 days)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
Study to assess the efficacy of treatment of autoimmune diabetes of adults (LADA) with metformin / dapagliflozin / saxagliptin against metformin / insulin glargine (LADA)ADAMedDRA version: 21.0Level: PTClassification code 10066389Term: Latent autoimmune diabetes in adultsSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2015-004723-31-ITIVERSITÀ CAMPUS BIO-MEDICO DI ROMA100
已完成
不适用
A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients Considering LHC as Treatment for NSTEMINSTEMINCT04270630NYU Langone Health14
已完成
2 期
Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe CervixLabor Onset and Length AbnormalitiesNCT04000438Dilafor AB365
已完成
不适用
High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe WastingSevere WastingSevere Acute MalnutritionNCT05737472The Hospital for Sick Children128
已完成
2 期
Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe AsthmaAsthmaNCT05104892Sanofi196