Comparative Evaluation of Childs Acceptance Towards Conventional Rubber Dam and Novel Kiddo Dam Sheet during dental procedure– A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Acceptability of children towards conventional rubber dam
研究概览
简要总结
Healthy children (ASA I), aged 6–10 years, reporting to the Department of Pediatric and Preventive Dentistry and requiring Class I restoration of bilateral primary mandibular molars, will be included in the study. Participants will be randomly allocated into two groups (Group 1 and Group 2) using a computer-generated random sequence. In Group 1, children will receive a Class I restoration of one mandibular molar using a conventional rubber dam during their first visit, followed by a restoration of the contralateral mandibular molar using the novel Kiddo dam after one week. In Group 2, the sequence will be reversed, with the novel Kiddo dam used in the first visit and the conventional rubber dam in the second visit. Children will have the option to select the design of the Kiddo dam based on their favorite cartoon character. After completing restorations with both types of rubber dams, children will complete a validated questionnaire to assess their acceptance and preference for the rubber dam sheets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Day(s) 至 10.00 Day(s)（—）
- 性别
- All
入选标准
- •• Healthy children (ASA I) of age six to ten years • Children requiring bilateral class I restoration of primary mandibular second molars.
- •• Children with no prior experience of rubber dam application for dental treatment • Presence of sufficient tooth structure to securely anchor the rubber dam clamp in place • Frankl’s behaviour rating scale, score three or four • Completion of informed consent to participate in the study by parents.
排除标准
- •Medically compromised children
- •Frankl’s behaviour rating scale, score I or II
- •Children known to have colour vision deficiency, blindness
- •Children known to have allergy to latex.
结局指标
主要结局
Acceptability of children towards conventional rubber dam
时间窗: at the time of procedure
sheets and novel Kiddo dam sheets while performing dental procedures.
时间窗: at the time of procedure
次要结局
- Impact on the rubber dam application sequence(After procedure)
研究者
Dr Anija CK
Government dental college & Hospital, Nagpur