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临床试验/CTRI/2024/03/064531
CTRI/2024/03/064531尚未招募2 期

A comparative evaluation of the efficacy of systemically and locally delivered Rubia cordifolia (Manjistha) as an adjunct to scaling and root planing in generalized moderate to severe chronic periodontitis patients – A Randomized Controlled Clinical Trial.

Pranav Kudale1 个研究点 分布在 1 个国家目标入组 92 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
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
GINGIVAL INDEX, PLAQUE INDEX, PROBING POCKED DEPTH REDUCTION

研究概览

简要总结

Patients having moderate to severe chronic periodontitis will be assigned randomly into 4 groups and will be given Rubia cordifolia mouthwash, capsules and placebo mouthwash according to the groups. Baseline records will be taken and scaling and root planing will be performed. Upon completion of scaling and root planing patint will be given above mentioned interventions according to their groups. then patient will be assesed at 1 week and 1 month interval and measurement will be recorded for plaque index, gingivl index, probing pocket depth, clinical attachment loss and then results will be drawn and published.

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, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Male

入选标准

  • 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).59
  • Patients in age group of
  • 60 years of either sex,
  • Patients with at least 20 natural teeth,
  • Patient ready to give written informed consent.

排除标准

  • • Medically compromised patients, • Patients on antibiotic or antimicrobial therapy in the past 6 months, • Smokers and smokeless tobacco users, • Patients who have received periodontal treatment in the past 6 months, • Pregnant women and lactating mothers, • Patients allergic to any material used in the study.

结局指标

主要结局

GINGIVAL INDEX, PLAQUE INDEX, PROBING POCKED DEPTH REDUCTION

时间窗: 1 week, 1 month

次要结局

  • CLINICAL ATTACHMENT LOSS(1 WEEK 1 MONTH)

研究者

发起方
Pranav Kudale
申办方类型
Other [Self sponsered]
责任方
Principal Investigator
主要研究者

Pranav Kudale

Govt. Dental College and Hospital Mumbai

研究点 (1)

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