Comparison of effectiveness of Manual and Powered toothbrushes in reduction of plaque and gingivitis-A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 2)Plaque Index (Loe and Sillness), (range:0-3)
研究概览
简要总结
AIM OF THE STUDY:
To assess the effectiveness of manual andpowered toothbrushes in controlling plaque and gingivitis among dental studentsof The Oxford Dental college and Hospital, Bengaluru.
OBJECTIVE OF THESTUDY:
To assess and to compare the effectiveness ofmanual and powered toothbrushes in the reduction of plaque and gingivitis overa period of six months.
SOURCE OF DATA:
First and second year B.D.S students of TheOxford Dental College and Hospital, Bengaluru.
STUDY DESIGN:
The study design will be Single blinded randomizedcontrolled trial (RCT). The sample size consists of 50 dental students (firstand second year B.D.S) of both the genders. The subjects will be randomly divided into two groups (Group –A and group–B) by a second investigator using a lottery method and brushingtechnique will be demonstrated and instructed to brush twice a day for 2minutes (once in the morning and once during night before sleeping). Baseline scores will be recorded and scaling and polishing will be done for allthe subjects. Group –A will be consisting of 25 subjects and will be given manualtoothbrushes [Oral-B Pro Health-soft] and will be instructed to use ModifiedBass method of brushing technique. Group- B will be consisting of 25 subjects and will be given poweredtoothbrushes [Oral-B Crossaction] and will be instructed to use the brush withthe bristles perpendicular to gingival margin or sulcus.
Subjects will be recalled at 7th, 14th,45thday, 3rd month and 6th month. The gingival scores will be recorded by a blinded assessor using Loe andSilness (1963) gingival index and the amount of plaque using Loe and Silness plaqueindex (1964) after using a Disclosing agent (two-tone).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Good general health.
- •No history of periodontal therapy during the past 3 months.
- •Full complement of teeth present, except third molars.
排除标准
- •Use of any antibiotics that could affect the state of the gingival tissues.
- •Who are undergoing or planning to undergo orthodontic treatment.
- •Subjects with multiple prosthesis.
- •Subjects who are already using powered toothbrushes.
结局指标
主要结局
2)Plaque Index (Loe and Sillness), (range:0-3)
时间窗: 7th day, 14th day, 45th day, 3rd month, 6th month
1)Gingival Index(Loe and Sillness),(range:0-3)
时间窗: 7th day, 14th day, 45th day, 3rd month, 6th month
次要结局
- Reduction in the plaque score.(6 months)