Evaluation of Amla (Emblica Officinalis) as an Adjunct to Non-surgical Periodontal Therapy in Patients With Chronic Periodontitis -A Clinical and Biochemical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in clinical parameters (bleeding index)
研究概览
简要总结
This study aimed to evaluate the influence of amla (Emblica officinalis) on patients with chronic generalized periodontitis, using a single-blind, randomized controlled study design.
- At baseline, all participants fulfilling the I/E criteria would be randomized into Arm I or II.
- All participants in Arm I and II would undergo scaling and root planing (SRP).
- After 1 month, Arm I participants would receive adjunct amla for 2 weeks, and Arm II participants would receive no treatment.
- Both arms would be followed until the end of 6 months and evaluated for clinical and biochemical parameters.
详细描述
The study is a randomized, single-blind, controlled trial, involving thirty chronic generalized periodontitis patients aged between 25 to 60 years. Participants fulfilling the Inclusion/ Exclusion criteria participants would be randomized to Arm I or II. They would be subjected to scaling and root planing (SRP). After 1 month, Arm I participants would be given amla for 2 weeks, while no adjunct therapy is planned for the participants in Arm II. Clinical parameters such as plaque index, gingival index, bleeding index, probing pocket depth, and clinical attachment loss would be assessed at baseline, 1, 3 and 6 months post-treatment. Biochemical parameters malondialdehyde (MDA) and glutathione (GTH) would be measured by spectrophotometry, while ELISA would be performed to assess the tumor necrosis factor-α (TNF- α), and C-reactive protein (CRP) in serum and saliva, at baseline and 6 months. Statistical analysis is proposed using SPSS or STATA 14 package.
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 (Investigator, Outcomes Assessor)
盲法说明
The investigator and outcome assessor were not aware of the arms or the intervention received. The additional intervention (amla dispensing) was conducted by another member, not involved in the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have at least 20 remaining teeth, with chronic generalized periodontitis, as defined as > 30 % sites involved (extent) and with moderate to severe involvement (severity) as characterized by > 2 interproximal sites with clinical attachment loss (CAL) > 4mm (not on the same tooth) AND/OR > 5 mm, probing depth (not on the same tooth) AND/OR > 2 interproximal sites with CAL > 6 mm AND 1 interproximal site with PD > 5mm.
- •Systemically healthy patients
排除标准
- •Medically compromised patients
- •Pregnant and lactating women
- •Patients on cholesterol-lowering medication
- •Patients who had received any antimicrobial therapy in the past 2 months, on ongoing antimicrobial therapy, or would receive antimicrobials during the course of the study.
- •Patients who had undergone any periodontal surgery in the past 6 months
- •Patients with a high caries index
- •Patients with severe tooth hypersensitivity
研究组 & 干预措施
Scaling and root planing + Amla
Arm I - This group of chronic generalized periodontitis patients would receive the standard of care i.e. scaling and root planing, followed by a full amla berry daily for 2 weeks.
干预措施: Scaling and root planing + Amla (Dietary Supplement)
Scaling and root planing
Arm II - This group of chronic generalized periodontitis patients received the standard of care i.e. scaling and root planing
干预措施: Scaling and root planing (Other)
结局指标
主要结局
Improvement in clinical parameters (bleeding index)
时间窗: 1,3 and 6 months
Improvement in bleeding index
Improvement in clinical parameters (plaque index)
时间窗: 1, 3 and 6 months
Improvement in plaque index
Improvement in clinical parameters (gingival index)
时间窗: 1,3 and 6 months
Improvement in gingival index
Improvement in clinical parameters (probing pocket depth)
时间窗: 1,3 and 6 months
Improvement in probing pocket depth
Improvement in clinical parameters (clinical attachment level)
时间窗: 1,3 and 6 months
Improvement in clinical attachment level
次要结局
- Changes in antioxidant levels (Malondialdehyde) in saliva and serum(6 months)
- Changes in antioxidant levels (glutathione) in saliva and serum(6 months)
- Changes in anti-inflammatory marker levels (CRP) in serum and saliva(6 months)
- Changes in anti-inflammatory marker levels (TNF-alpha) in serum and saliva(6 months)
研究者
Dr Grace Tara Paul
Professor
Mahatma Gandhi Postgraduate Institute of Dental Sciences