A COMPARATIVE EVALUATION OF THE EFFECT OF TRIPHALA AND CHLORHEXIDINE MOUTHWASH ON DENTAL PLAQUE, GINGIVAL INFLAMMATION AND MICROBIAL GROWTH IN 14-15 YEARS OLD SCHOOL CHILDREN - A RANDOMIZED CONTROLLED DOUBLE BLIND CLINICAL TRIAL.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- 1.To assess the effect of Triphala and Chlorhexidine mouthwash on dental plaque score and gingivitis score and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from the dental plaque samples.
研究概览
简要总结
This study is a randomized controlled double blind parallel three month clinical trial conducted among 72 school children of age group of 14-15 years, who are divided into two study groups: Group A- Triphala mouthwash (n=36) and Group B- Chlorhexidine mouthwash (n=36). The microbial counts were measured by conventional culture methods and plaque scores and gingival scores were recorded by using Plaque Index [Loe H (1967)] and Gingival Index [Loe H and Silness J (1963)] respectively at baseline, 30 days and 90 days interval. The primary outcome is to assess and compare the effect of 0.4% Triphala and 0.12% Chlorhexidine mouthwash on dental plaque, gingival inflammation and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from dental plaque sample of 14-15 years old school children during 90 days supervised use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Study participants of age group 14-15 years 2.Study participants with similar i.socioeconomic status [Based on Kuppuswammy’s Socioeconomic status scale], ii.oral hygiene methods 3.At least 20 intact natural teeth should be present.
- •4.Study participants with fair plaque score (Loe H 1967) and moderate gingivitis (Loe H and Silness J 1963) were selected.
- •5.Study participants willing to participate in the study and whose parents gave a written informed consent.
排除标准
- •1.History of hypersensitivity to any product used in the study and other oral care products.
- •2.Unable to comply with the study appointment schedules.
- •3.Any oral soft tissue pathology.
- •4.Grossly decayed teeth and over-retained deciduous teeth.
- •5.Study participants having calculus 6.Suffering from non-plaque induced gingivitis or periodontitis.
- •7.Study participants with any systemic disorders that require the use of medications with side effects known to affect oral health.
- •8.Study participants using mouth rinse within the last 3 months.
- •9.Study participants under antimicrobial therapy at least 3 month prior to the study and using mouth rinses or dentifrices containing substances with anti-inflammatory properties.
- •10.Study participants with crowns or restorations on facial and lingual surfaces of teeth.
- •11.Study participants with malocclusion or fixed/ removable orthodontic appliances.
- •12.Study participants who are physically or mentally handicap.
结局指标
主要结局
1.To assess the effect of Triphala and Chlorhexidine mouthwash on dental plaque score and gingivitis score and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from the dental plaque samples.
时间窗: The demonstration regarding th use of mouthwash and the collection of plaque sample was done at 0 day, 30th day and at 90th day
3.To compare the effect of Triphala and Chlorhexidine mouthwash on dental plaque, gingival inflammation and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from the dental plaque samples
时间窗: The demonstration regarding th use of mouthwash and the collection of plaque sample was done at 0 day, 30th day and at 90th day
次要结局
未报告次要终点