Evaluation of Thermoreversible Avocado-based Gel as an Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients: A Clinical And Microbiological Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Papilla Bleeding Index
研究概览
简要总结
The goal of this clinical trial is to learn if the herbal gel is more effective as compared to placebo in reducing periodontal inflammation in patients with periodontal disease.
The clinicians shall check various periodontal parameters in the subjects over a scheduled duration.
Participants will be administered the gel once subgingivally and the periodontal parameters shall be recorded before gel delivery then again after 1,3 and 6 months.
Plaque samples were taken at baseline and 6 months
详细描述
Chronic periodontitis is a prevalent inflammatory condition primarily caused by bacterial plaque biofilm, leading to progressive attachment and bone loss. Scaling and root planing (SRP) is the gold standard for its management. Recently, natural and herbal-based adjuncts have gained attention for their antimicrobial and anti-inflammatory properties. This study aimed to evaluate the clinical and microbiological effectiveness of 4% avocado gel as an adjunct to SRP in the treatment of chronic periodontitis.
A randomized controlled clinical trial was conducted on patients diagnosed with chronic periodontitis. Subjects were divided into two groups: Group I received SRP with subgingival application of placebo gel, and Group II received SRP along with subgingival application of 4% avocado gel. Clinical parameters, including Plaque Index (PI), Papilla Bleeding Index (PBI), Probing Pocket Depth (PPD), and Relative Attachment Level (RAL), were recorded at baseline and after 4th week and 12th week. Microbiological analysis was conducted at recorded at baseline, 4th week,12th week and 24th week to assess the presence of Porphyromonas gingivalis and Prevotella intermedia using culture methods.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Chronic periodontitis having periodontal pockets (non-adjacent sites) of >5mm
排除标准
- •history of any systemic disease, Antibiotic treatment during the 6 months period prior to the study, Pregnant and lactating woman, Periodontal treatment during the previous 3 months, Severe caries or extensive restoration on the objective teeth.
研究组 & 干预措施
scaling and root planing with subgingival application of placebo gel
scaling and root planing of the entire dentition followed by subgingival application of placebo gel in selected site
干预措施: placebo gel (Drug)
scaling and root planing with subgingival application of thermoreversible herbal gel
scaling and root planing of the entire dentition followed by subgingival application of herbal gel in selected site
干预措施: herbal drug (Drug)
结局指标
主要结局
Papilla Bleeding Index
时间窗: 3 months
Plaque Index
时间窗: 3 months
Probing Pocket Depth
时间窗: 3 months
Relative Attachment Level
时间窗: 3 months
次要结局
- CFUs(6 months)
研究者
Karthik Krishna M
Principal Investigator
Rungta College of Dental Sciences and Research