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临床试验/CTRI/2025/01/079505
CTRI/2025/01/079505尚未招募3 期

comparision of efficacy of punica granatum and citrus paradisi herbal extract mouthrinse with chlorhexidine gluconate mouth rinse in treatment of stage 1 periodontitis:a clinical and biochemical study

Dr Harshitha C1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月10日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the efficacy of punica granatum and citrus paradisi herbal extract mouth rinse with chlorhexidine gluconate mouth rinse in stage one periodontitis

研究概览

简要总结

Mouthwashes containing plant extracts which have no adverse effects are being used for their antiplaque and anti-inflammatory properties in the treatment of chronic gingivitis. Hence an attempt is being made to test and compare the efficacy of a combination herbal mouthwash with commercially available chlorhexidine mouthwash.

Material:

The formulation will be procured from Group Pharmaceuticals Pvt Lmt. Bengaluru. Biochemical analysis of saliva will be done is department of Biochemistry, JSS Medical College, Mysuru.

Study Design: This is a single blind clinical and biochemical study to compare the efficacy of a combination of punica granatum and citrus paradisi herbal mouth rinse with a currently marketed chlorhexidine mouth rinse in patients with stage 1 periodontitis.

Method:

Subjects who fulfil the inclusion criteria will be included in the study and will be randomly allocated to three treatment groups after scaling and oral hygiene instructions

Group A: Herbal Mouth Rinse containing punica granatum and citrus paradisi. Group B: 0.2 % Chlorhexidine Mouth rinse.

Group C: Scaling and root planing.

Clinical parameters to be recorded are:

Clinical parameters will be evaluated at the baseline, 15th and 30th day by a single calibrated examiner.

·      Plaque index (Silness and Loe,1964)

·      Sulcus bleeding index (Muhlemann-son)

·      Probing Pocket Depth

·      Clinical Attachment Level

The saliva samples will be collected at baseline and 30 days using a sterile Eppendorf tube and will be sent for biochemical analysis which will include measuring the total interleukin 1 β level in the sample.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • •1.age:18-55 years
  • •presenceof atleast 20 natural teeth
  • •plaque and gingival index more than or equal to 1.5
  • •probing depth not more than 4mm.

排除标准

  • •h/o periodontal treatment in last 6 months h/o antibiotic and anti inflammtory usage during 6 months h/o of known systemic disease that would alter the healing response of oraltissue smokers smoking or use of tobacoo in any form pregnant anf lactating women.

结局指标

主要结局

To compare the efficacy of punica granatum and citrus paradisi herbal extract mouth rinse with chlorhexidine gluconate mouth rinse in stage one periodontitis

时间窗: 30 days

次要结局

  • to asses the salivary Interleukin 1 beta levels(30 days)

研究者

发起方
Dr Harshitha C
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrHarshithaC

JSS DENTAL COLLEGE AND HOSPITAL

研究点 (1)

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