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临床试验/CTRI/2019/06/019889
CTRI/2019/06/019889尚未招募Phase 3 4

Comparative evaluation of the efficacy of 5% Indian Jamun Extract and 0.2% Chlorhexidine Gluconate Mouthwash in Prevention of Plaque and Gingivitis among young adults: An Invivo In-vitro Randomized Clinical Trial

Dr Karina Chachlani1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月18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
60
试验地点
1
主要终点
To evaluate and compare in-vivo and in-vitro efficacy of 5% Indian Jamun extract..in vitro testing will be done on agar plates with 3 organisms (Streptococcus mitis porphyromonas gingivalis, tanerella forsythia) and in vivo testing will be done by taking plaque and gingival bleeding index at baseline, 7th day, 14th day and 21st day

研究概览

简要总结

Periodontal diseases are chronic inflammatory conditions characterized by loss of connective tissue, alveolar bone resorption and formation of periodontal pockets as a result of the complex interaction between pathogenic bacteria and the host′s immune response. Periodontitis starts with inflammatory lesions of the gingiva, which, if left untreated, may progress and eventually involve and compromise the entire periodontal apparatus of the affected teeth. Dental plaque is the primary etiologic factor in periodontal disease.The results of the clinical trials and analysis of literature indicates a strong correlation between microbial plaque levels and severity of gingivitis. Plaque control has long been considered as the cornerstone of its management.

Mechanical hygiene procedures such as tooth brushing, interdental brushing, and dental floss are the key methods of plaque control. However, despite the potential for adequate mechanical plaque control, clinical experience and population-based studies demonstrate that such methods are not being employed sufficiently by large numbers of the population.

Chemical methods of reducing plaque, such as mouthwashes, are less technically demanding alternatives to mechanical plaque control. Chlorhexidine gluconate is the most popular mouthwash which has been recognized by the pharmaceutical industry as the positive control against which the efficacy of alternative antiplaque agents should be measured, and has earned its epitome of gold standard. But its long-term usage may result in various side effects. An effective substitute to chlorhexidine gluconate with all the good qualities and its unpleasant effects is highly desirable and has been long awaited.

From the earliest times, Plants have been exploited by humans for many centuries as sources of medicinal drugs, due to the presence of various bioactive compounds. Plants have not only provided food, cosmetics and embalming ointments, but also a plethora of easily available remedies for the maladies of humanity3. As the popularity of these herbal products continues to rise, dental professionals are expected to provide information to patients about these products safety and efficacy. So herbal mouthwash may act as a good and cost-effective oral hygiene product.

Eugenia jambolana Lam., commonly known as black plum or “jamun†is an important medicinal plant in various traditional systems of medicine. It is effective in the treatment of diabetes mellitus, inflammation, ulcers and diarrhoea and preclinical studies have also shown it to possess chemopreventive, radioprotective, antineoplastic, antiviral, antibacterial and antioxidant properties but most important of all is antidiabetic property . The plant is rich in compounds containing anthocyanins, glucoside, ellagic acid, isoquercetin, kaemferol and myrecetin(4). The seeds are claimed to contain alkaloid, jambosine, and glycoside jambolin or antimellin, which halts the diastatic conversion of starch into sugar. The plant is however less explored for dental use .

Therefore, the present study is conducted to Compare the efficacy of 5% Indian Jamun extract mouthwash with 0.2% Chlorhexidine gluconate mouthwash against plaque accumulation and gingivitis among young adults.

Primary hypothesis: There is no difference between the efficacy of 5% Indian Jamun extract mouthwash and 0.2% Chlorhexidine gluconate mouthwash on plaque accumulation and gingivitis.

Other hyposthesis 1: 5% Indian Jamun extract mouthwash is less effective than 0.2% Chlorhexidine gluconate mouthwash in prevention of plaque accumulation and gingivitis.

Other hypothesis 2: 5% Indian Jamun extract mouthwash is as good as 0.2% Chlorhexidine gluconate mouthwash in prevention of plaque accumulation and gingivitis.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant and Outcome Assessor Blinded

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 in age group of 18 to 30 years.
  • Subjects following routine oral hygiene procedures.
  • Subjects with mild to moderate gingivitis.
  • 4.Subjects willing to participate in the present study.

排除标准

  • 1.Subjects suffering from systemic diseases.
  • 2.Subjects undergoing orthodontic treatments.
  • 3.Subjects using other aids for oral hygiene apart from toothbrush.
  • 4.Subjects having adverse habits like smoking, alcohol drinking.
  • 5.Subjects not willing to participate in the present study.

结局指标

主要结局

To evaluate and compare in-vivo and in-vitro efficacy of 5% Indian Jamun extract..in vitro testing will be done on agar plates with 3 organisms (Streptococcus mitis porphyromonas gingivalis, tanerella forsythia) and in vivo testing will be done by taking plaque and gingival bleeding index at baseline, 7th day, 14th day and 21st day

时间窗: 7th, 14th and 21st day

mouthwash with 0.2% Chlorhexidine gluconate mouthwash on plaque accumulation and gingivitis among young adults at baseline, 7th, 14th and 21st day.

时间窗: 7th, 14th and 21st day

次要结局

  • 1. To evaluate the efficacy of mouthwash containing 5% Indian Jamun extract on gingivitis(and plaque accumulation and it’s comparison with 0.2% chlorhexidine gluconate mouthwash among young adults at baseline, 7th, 14th and 21st day (in vivo) using plaque index and gingival bleeding index)

研究者

发起方
Dr Karina Chachlani
申办方类型
Other [self]

研究点 (1)

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