Evaluating the effectiveness of herbal tooth paste on dental plaque and gingival health: A pilot study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dental plaque and gingival health will be assessed using modified Quigley Hein plaque index and Loe H & Silness P gingival index respectively.
研究概览
简要总结
This is a pilot study to evaluate the effectiveness of herbal tooth paste on dental plaque and gingival health against commercially available tooth paste. Before the start of the study, written consent will be taken from the patients. A total sample of 60 volunteers will be included in the study. The 60 volunteers will be assigned randomly into two groups, namely Group A, i.e. the Control group and Group B i.e. the Test group equally. 30 volunteers in Group A will receive Colgate with amino shakti tooth paste as control and 30 volunteers in Group B will receive Edinora prime tooth paste. All the study participants will receive a Colgate medium tooth brush for brushing. Participants will be advised to brush twice daily for 2-3 minutes, using pea size amount of tooth paste. The weight of tooth paste will be measured and recorded on the first visit before the distribution and on the last visit. On the first visit participants will be asked to report in the morning, i.e., approximately 12 hours after oral hygiene for baseline sampling. Oral examination will be carried out and dental plaque will be assessed using modified Quigley Hein plaque index and gingivitis will be scored using Loe H & Silness P gingival index. After the oral examination, demonstration of modified bass method of brushing will be given using a study model and later the tooth paste and tooth brush will be distributed based on the assigned group. The oral examination will be conducted by trained dentist and the dentist will be blinded. Plaque disclosing agent will be used for scoring the dental plaque. The second visit will be on the 15th day after the initial visit and plaque index and gingival index will be recorded. The final visit will be on the 30th day and plaque index and gingival index will be recorded and the participants will be asked to return the remaining tooth paste to the researcher. All the study participants will be blinded throughout the study. The collected data will be used for statistical analysis and the statistician will be blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Individuals who are willing to participate in the study.
- •Males and females in good general health aged 18 to 30 years available for the duration of the study.
- •A minimum of 20 natural teeth with facial and lingual scorable surfaces.
排除标准
- •Individuals who are under antibiotics or anti-inflammatory drugs.
- •History of dental prophylaxis or treatments in the past month.
- •Individuals undergoing orthodontic treatment.
- •History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
- •History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases.
- •Individuals with oral soft tissue pathology.
- •History of active or severe periodontal disease with bleeding gums and loose teeth.
结局指标
主要结局
Dental plaque and gingival health will be assessed using modified Quigley Hein plaque index and Loe H & Silness P gingival index respectively.
时间窗: baseline data on 1st day and second assessment on 15th day and final data collection on 30th day.
次要结局
- Oral hygiene will be assessed(at the 15th day and 30th day)