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临床试验/CTRI/2024/03/064678
CTRI/2024/03/064678招募中2 期

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

Ajit Metkar1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年5月1日最近更新:

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

发起方
Ajit Metkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ajit Metkar

215 department of periodontology

研究点 (1)

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