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临床试验/CTRI/2026/02/104466
CTRI/2026/02/104466尚未招募Phase 3 4

COMPARATIVE EVALUATION OF ANTI-PLAQUE AND ANTI-GINGIVITIS EFFICACY OF STOLIN R AND OMNIDENT AS TOOTHPASTE IN CHRONIC GENERALISED GINGIVITIS PATIENTS - A RANDOMIZED CLINICAL TRAIL

Dr PULLALAREVU DIVYA SAI1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月16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
30
试验地点
1

研究概览

简要总结

Plaque induced gingivitis is the second most common oral disease after dental caries. It is thought to affect at least 75% of the population worldwide. Gingivitis begins in the childhood and its prevalence increases with age. It has been reported that plaque induced gingivitis is seen in dentate individuals of all age group. Self-performed mechanical plaque removal is a proven method of controlling plaque and gingival disease. However, tooth brushing and flossing are difficult tasks and depend on individual dexterity.

Several chemical preventive agents have beneficial effects in the control of plaque and to reduce or prevent oral disease. Hence, various chemical formulations were tried in dentifrices. Chemicals, mainly triclosan and chlorhexidine, have been added in mouth rinses and dentifrices to prevent plaque and gingivitis.

Oral hygiene includes any or all of the procedures that contribute to a state of good oral health. To achieve improved oral health, many techniques and products are available nowadays, such as toothbrushes, rinses, floss, and dentifrices. The commonly used dentifrices are synthetic and contain chemical agents that are known to produce harmful side effects with prolonged use.

Chlorhexidine is one of the most effective supragingival plaque control agents. However, in a toothpaste preparation, a significant reduction of its antiplaque potential may be observed. Triclosan has also shown a significant reduction in plaque and gingivitis. Additional research is required for antimicrobial dentifrices that are comparatively less abrasive in controlling bacterial plaque. Controlled clinical trials have demonstrated that brushing teeth with dentifrices reduces supragingival plaque as well as gingivitis.

It is commonly observed that daily brushing often fails to achieve optimum gingival health Data from India show that every second person above the age of 35 years has gum pockets and 35% of total teeth extracted after the age of 35 years are due to periodontal disease. Prevalence of gingivitis in India is 80-90%. Triclosan (2,4,4’ trichlor-2’-hydroxydiphenyl ether) is a non-ionic chlorinated bisphenol widely used in personal Products such as deodorants and soaps and appears to be safe, effective and well tolerated.

It is compatible with toothpaste components such as fluoride and surfactants and, by virtue of its inhibition of cyclo-oxygenase/lipoxygenase pathways, is also anti-inflammatory. However, triclosan per se has only moderate substantivity and is not retained sufficiently long to have a significant antibacterial effect. Studies have shown that triclosan combined with CoPolymer PVM/MA or PPI has higher retention and substantivity. However, the benefit of short term and routine use of triclosan  dentifrices on reduction of gingivitis is not studied.

The need for the study arises to compare the effect of two dentifrices with and without triclosan against plaque and gingivitis.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Individuals with at least 20 natural teeth.
  • subjects with a gingival index greater than 1 (as measured by Loe and Silness, 1963) subjects with a plaque index of greater than 1 (as measured by the plaque index by Silness J, Loe H-1964).

排除标准

  • Subjects with known systemic disease.
  • Patients under anti-inflammatory, antibiotic, or antimicrobial therapy in the past 6 months.
  • Smokers and smokeless tobacco users.
  • Patients who have undergone periodontal treatment in the past 6 months.
  • Subjects who are allergic to any material used in the study.

研究者

发起方
Dr PULLALAREVU DIVYA SAI
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

PULLALAREVU DIVYA SAI

Sri Rajiv Gandhi College of Dental Sciences and Hospital

研究点 (1)

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