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临床试验/CTRI/2025/07/090187
CTRI/2025/07/090187尚未招募Phase 3 4

Comparative evaluation of the efficacy of herbal mouthwash with chlorhexidine mouthwash, as an adjunct to scaling and polishing in the treatment of subjects with mild to moderate gingivitis- a randomized clinical trial

Yerala Dental College1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Gingival index

研究概览

简要总结

Gingivitis is caused by plaque accumulation on tooth surfaces. The bacteria produce toxic antigens that lead to an inflammatory reaction in the gingival tissue. Gingivitis can eventually evolve to periodontitis with loss of supporting bone and periodontal attachment around the teeth. Chlorhexidine which is a broad-spectrum antimicrobial agent is considered as the gold standard for chemical plaque control. But continuous use of chlorhexidine has side effects such as increase in calculus formation, alteration in taste, oral mucosal erosion . Gingivitis is caused by plaque accumulation on tooth surfaces. The bacteria produce toxic antigens that lead to an inflammatory reaction in the gingival tissue. Gingivitis can eventually evolve to periodontitis with loss of supporting bone and periodontal attachment around the teeth. Chlorhexidine which is a broad-spectrum antimicrobial agent is considered as the gold standard for chemical plaque control. Herbal medicine have long been used as mouthwash and this practice is still relevant in many regions. The present study aims to evaluate and compare the efficacy of herbal mouthwash pre and post after use. It also aims to evaluate the adverse drug reaction caused on using chlorhexidine  mouthwash.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • subjects with age group between 18 to 30 years 2)subjects with minimum 20 teeth present 3)subjects with mild to moderate gingivitis 4)systemically healthy and cooperative subjects 5)subjects willing to take part in study.

排除标准

  • presence of fixed or partial dentures or removable dentures 2) subjects with history of antibiotic and anti inflammatory drugs within 1 month 3) pregnant women , women on oral contraceptive medication and lactating mothers 4) subjects who are smokers.

结局指标

主要结局

Gingival index

时间窗: baseline and 21 days

Plaque index

时间窗: baseline and 21 days

OHI-s

时间窗: baseline and 21 days

次要结局

  • 0.0-1.2 good oral hygiene(1.3-3.0 fair)

研究者

发起方
Yerala Dental College
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

DR SANGEETA MUGLIKAR

Intern

研究点 (1)

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