Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis: (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clinical attachment level
研究概览
简要总结
The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function,
- •Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI
- •Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene.
- •No history of systemic disease that may influence periodontal disease
排除标准
- •Pregnancy or breastfeeding,
- •Smokers with more than seven cigarettes per day
- •Patients that had a treatment with antibiotics within six months before the study
- •Need for periodontal surgery or adjunctive antibiotic treatment to the SI
- •Patients who had any periodontal treatment during the last year before the study.
- •Patients with known systemic or autoimmune disease.
研究组 & 干预措施
Test Group I (GBT and SI + erythritol powder)
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + erythritol powder
干预措施: GBT and SI with erythritol powder (Device)
Test Group II (GBT and SI + glycine powder)
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + glycine powder
干预措施: GBT and SI with glycine powder (Other)
Test Group III (GBT and SI + Trehalose powder)
will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + Trehalose powder
干预措施: GBT and SI with trehalose powder (Other)
Control Group VI (SRP and SI)
will receive conventional Scaling and Root planning (SRP) and (SI) without adjunctive air polishing powder
干预措施: SRP and SI (Other)
结局指标
主要结局
Clinical attachment level
时间窗: up to six months
Bleeding on probing
时间窗: up to six months
Pain Assessment
时间窗: up to six months
Pain level will be assed using Visual Analogue Scale (VAS) from 1 (minimum) to 10 (maximum)
Probing depth
时间窗: up to six months
Plaque accumulation
时间窗: up to six months
Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)
时间窗: one month
Microbiological Assessment of Porphyromonas gingivalis (Pg)
时间窗: one month
Microbiological Assessment of Tannerella forsythia (Tf)
时间窗: one month
Microbiological Assessment of Treponema denticola (Td)
时间窗: one month
次要结局
未报告次要终点
研究者
Diana Ibrahim
Periodontology MSc. Candidate
Alexandria University