Evaluation of Child’s behaviour, Anxiety level, Operators convenience during dental care procedure with Rubber dam, Mini dam , Optra dam isolation technique. – A Randomized Control Trial .
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Reduced anxiety, good cooperation of child’s behaviour in Optra dam isolation technique.
研究概览
简要总结
Participants will be selected from the patient reporting to pedodontics department for the restoration of teeth . Participants will be divided into three group by inclusion and exclusion criteria . using coin toss method individuals will be randomly divided into three group and totally 75 participants will be be taken into account.group1(25):rubber dam , group2(25):mini dam,group3(25): Optra dam . The procedure will be explained to the participants verbally and using audiovisual aids . prior to placement of three isolation technique two percent lignocaine local anesthesia is given. then anxiety level will be assessed during baseline and during the placement of rubber dam, mini dam, optra dam, using animated visual anxiety rating scale , ghanashyam prasad M et al ,2022 .Childs behaviour will be assessed using modified frankle behaviour rating scale, Machen and Johnson,1991. Operators convenience will be assessed by stopwatch.
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 Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adequate tooth structure.
- •2.Patient who are willing to be a part of the study .
- •3.Children between 6-12yrs of age .
- •4.Patient with multiple sitting procedures.
排除标准
- •1.Unrestorable teeth, partially erupted tooth 2.Children with special health care needs.
- •3.Patient with systemic illness.
- •4.Extremely malpositioned teeth.
- •5.Patient with latex allergy .
- •6.Periodontally weakened tooth .
结局指标
主要结局
Reduced anxiety, good cooperation of child’s behaviour in Optra dam isolation technique.
时间窗: these parameters will be assessed at baseline and after placement of each dams.
次要结局
- less time consuming in Optra dam isolation technique when compared to mini dam,Optra dam.(will be assessed at the baseline & after placement of each dam)
研究者
Dr Sherin A
Karpaga Vinayaga Institute Of Dental Sciences