A COMPARATIVE EVALUATION OF EFFICACY OF SYSTEMICALLY AND LOCALLY DELIVERED BARLERIA PRIONITIS LINN (VAJRADANTI) AS AN ADJUNCT TO SCALING AND ROOT PLANING IN GENERALIZED MODERATE TO SEVERE CHRONIC PERIODONTITIS PATIENTS - A RANDOMISED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Plaque index gingival index
研究概览
简要总结
Abstract:
Periodontitis is initiated by the accumulation and maturation of pathogenic biofilm on the surface of teeth and oral mucosa. Ayurvedic drug such as Barleria prionitis linn (vajradanti) shows anti-inflammatory, anti-plaque action as an adjunct to scaling and root planing (SRP) in gingivitis, showed a significant reduction in plaque formation, gingival bleeding and pocket depth.This study aims toevaluate the therapeutic efficacy of Barleria Prionitis Linn (vajradanti) adjunct to scaling and root planing therapy in generalised moderate to severe chronic periodontitis patients. A Randomised Conrolled Clinical Trial was conducted on 96 patients will were randomly divided into 4 groups i.e. Group 1: placebo mouthwash and placebo capsule, Group 2: placebo mouthwash and Barleria prionitis linn capsule, Group 3: Barleria prionitis linn mouthwash + placebo capsule, Group 4: Barleria prionitis linn mouthwash and Barleria prionitis linn capsule. After scaling and root planing, the above drugs were prescribed to each group. Clinical periodontal parameters are recorded at baseline and 1 month. This study gives new direction, importance, and evaluation of significant pathways to treat periodontal diseases by ayurvedic drugs(Barleria prionitis linn). The required capsule and mouthwash will be provided by Sri Saptashrungi Ayurvedic College and Hospital, Nashik
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •ï‚·Patients with generalized moderate to severe chronic periodontitis (Greater than 3 mm of Clinical Attachment Loss), according to 1999 International workshop for the classification of the periodontal diseases organized by the American Academy of Periodontology (AAP). (60) ï‚·Patients in age group of
- •60 years of either sex, ï‚·Patients with at least 20 natural teeth, ï‚·Patient ready to give written informed consent.
排除标准
- •ï‚·Medically compromised patients, ï‚·Patients on antibiotic or antimicrobial therapy in the past 6 months, ï‚·Smokers and smokeless tobacco users, ï‚·Patients who have received periodontal treatment in the past 6 months, ï‚·Pregnant women and lactating mothers, Patients allergic to any material used in the study.
结局指标
主要结局
Plaque index gingival index
时间窗: 1 week 1 month
次要结局
- probing pocket depth(clinical attachment level)
研究者
Ajit Metkar
215 department of periodontology
