Clinical and microbiological efficacy of 3% satranidazole and 0.8% hyaluronic acid oral insitu gels as an adjunct to scaling and root planing in the treatment of stage 1 and stage 2 periodontitis.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Reduction in probing depth ,gain in clinical attachment levels and bacterial count
研究概览
简要总结
Periodontitis is an oral disease characterized by microbially associated, host mediated inflammation in the periodontium. In the pathophysiology of periodontitis, the loss of marginal periodontal ligament fibres is observed, junctional epithelium, migrates apically which causes biofilm to spread in apical direction along root surface. Treatment to manage periodontal disease can involve mechanical debridement, which includes scaling and root planing (SRP)
At the initial visit, a clinical examination will be performed on each patient and clinical parameters such as plaque index, gingival index, pocket depth and clinical attachment level will be recorded. At baseline all the patients will receive phase I therapy which includes Supragingival scaling and thorough oral hygiene instructions. Patients will be recalled after one week for Subgingival plaque sample collection. One week after scaling and root planning, baseline subgingival plaque sample will be collected using sterile curettes. The collected sample will be immediately transferred to a transport medium and sent to laboratory for microbiological analysis of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa) by using multiplex PCR.
In Group A subgingival scaling and root planing will be done and satranidazole gel is placed. In Group B after subgingival scaling and root planing hyaluronic acid gel will be injected into the pocket until the material is detected at the gingival margin. Then periodontal dressing (coe-pak) will be placed on treated site to ensure that gel will stay long enough to be effective in the pocket. After one-week periodontal dressing is removed.
Clinical parameters will be recorded after 1 month and 3 months after treatment and post operative subgingival plaque samples will be collected from two groups and sent for microbiological analysis after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group of 35-55 years of both the gender.
- •2.Apparently Healthy individuals 3.Subjects with Stage I (Interdental CAL – 1 to 2 mm, radiographic boneloss less than 15% of coronal third, maximum probing depth less than or equal to 4mm) and Stage II periodontitis (Interdental CAL – 3 to 4mm, radiographic bone loss 15- 33% of coronal third, maximum probing depth less than or equal to 5mm) 4.Subjects who are willing to give informed consent.
排除标准
- •Subjects using any form of tobacco.
- •History of previous antibiotic therapy within the past 3 months
- •Subjects who has history of drug allergy.
- •Pregnant woman and Lactating mothers.
- •Subjects with Stage III and Stage IV periodontitis.
结局指标
主要结局
Reduction in probing depth ,gain in clinical attachment levels and bacterial count
时间窗: Baseline 1 month 3 months
次要结局
- Decreased plaque and gingival score(Baseline 1 month 3 months)
研究者
Upputuri venga urekha
Sibar institute of dental sciences