Assessment of customized cushioning of rubber dam clamps in comparison with conventional clamps among 7 to 12 year old children A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Rubber dam isolation is the gold standard for moisture control during dental procedures, but the placement of conventional metal clamps in children can cause gingival trauma, pain, and slippage due to the anatomical features of primary teeth. Cushioning materials have been introduced to reduce direct metal contact with gingival tissues and improve patient comfort, though commercially available options are limited. Customized cushioning using polyvinyl siloxane material may provide a protective barrier, reduce tissue injury, and improve clamp stability. This randomized control trial aims to assess the effectiveness of customized cushioned rubber dam clamps compared with conventional metal clamps in children aged 7 to 12 years based on gingival trauma, sealing ability, clamp slippage, and patient pain perception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between the ages of 7 and 12 years who are in good general and physical health, whose child and parent are willing to participate in the study, presenting for their first dental visit, and having Class I caries involving only the enamel or enamel and dentin of the right and left primary mandibular posterior teeth will be included.
排除标准
- •Children with the presence of orthodontic appliances, diagnosed mental or physical health issues, motor impairments, Class II or Class V caries, gingival issues including gingivitis, or latex allergy will be excluded from the study.
研究者
Vidya S
SRM Kattankulathur Dental College