The Effectiveness Evaluation of the Theobromine Containing Toothpastes in Controlling Dental Plaque in Children Aged 6-9years(Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical evaluation of using low- fluoridaed toothpaste for children
研究概览
简要总结
Since plaque control forms the basis for caries prevention, the type of toothpaste and its constituents becomes more important.
Toothpaste containing fluoride are widely popular and fluorides have been historically reported to have effects against dental caries. However, the fluoride safe doses are still discussed ,because fluoride has toxicity and causing fluorosis.
The aim of the current research is to find alternative agent that can be used without side effects.
详细描述
Participants will be examined to ensure that they have met the smple entrey criteria,then the participants will be randomly assigned to four groups each one according to a group:
- A group of children using low-fluoridated toothpaste (500ppm)
- A group of children using fluoridated toothpaste (1450ppm)
- A group of children using theobromine toothpaste (2%)
- A group of children using low-fluoridated toothpaste (4%) The researcher will teach the participants how to brush using (tell-show-do)technique.
- The brushing method that will be used is the fones technique.
- Brushing duration must be 2minutes.
- Frequency of brushing must be twice a day
- The amount of toothpaste used is pea size.
Mechanism of examination and follow up:
A thorough scaling and plaque removal was conducted and the children were advised to brush their teeth using their regular toothpaste for a week before starting the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of age group 6to 9 years.
- •Participant must have least 20 teeth free from dental cries on both buccal and lingual surfaces of the teeth.
- •Cooperative children having behavioral rating (positive or definitively positive)according to frankel's behavior rating scale.
- •Children who are not on any medication prior or during the study period
排除标准
- •children with systemic diseases and medically compromising conditions.
- •children undergoing orthodontic treatment or with an intraoral prosthesis.
- •children who could not brush their teeth or rinse on their own.
- •Allergic to any of the toothpaste ingredient used the study.
研究组 & 干预措施
Children using fluoridated toothpaste
干预措施: Evaluation of the effectiveness of fluoridated toothpaste. (Other)
Children using low- fluoridated toothpaste
干预措施: Evaluation of the effectiveness of low- fluoridated toothpaste. (Other)
Children using Theobromine toothpaste (2%).
干预措施: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste. (Other)
Children using Theobromine toothpaste(4%)
干预措施: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste. (Other)
结局指标
主要结局
Clinical evaluation of using low- fluoridaed toothpaste for children
时间窗: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using fluoridated toothpaste for children
时间窗: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(2%) for children
时间窗: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(4%) for children
时间窗: 3 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using low- fluoridaed toothpaste for children
时间窗: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using low- fluoridaed toothpaste for children
时间窗: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using fluoridated toothpaste for children
时间窗: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using fluoridated toothpaste for children
时间窗: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(2%) for children
时间窗: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(2%) for children
时间窗: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(4%) for children
时间窗: 1 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
Clinical evaluation of using theobromine toothpaste(4%) for children
时间窗: 2 week
Plaque scores will be assess by using the Turesky Modification of the Quigley-Hein Plaque Index(TMQHPI) for both buccal and lingual surfaces. Plaque will detect using plaque disclosing agent. Gingival scores will be assessed with gingival index(loe and silness).
次要结局
未报告次要终点