Comparative Evaluation of the Effectiveness of Photobiomodulation, Cryo-Anaesthesia and Topical Anaesthesia Gel in Reduction of Pain Perception During Local Anaesthesia Administration in Children Aged 8-12 Years: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluation of Reduction in Pain Perception during Local Anaesthesia Administration using Photobiomodulation, Cryo-Anaesthesia and Topical Anaesthesia Gel in Children Aged 8-12 Years.
研究概览
简要总结
This is an in-vivo, randomized parallel group, three-arm clinical study evaluating the effectiveness of Photobiomodulation, Cryo- Anaesthesia and Topical Anaesthesia Gel in reduction of pain perception during local anaesthesia administration in children aged 8-12 years. The study will be conducted at the Department of Pediatric and Preventive Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, Belagavi, and will include 48 children requiring dental treatment under the inferior alveolar nerve block anaesthesia technique. The principal investigator will perform the procedure under standard operating protocols. The selected child will be made to sit comfortably on the dental chair, the procedure will be completely explained to the parent as well as the child by the principal investigator. A case history will be recorded for the present study so as to have a systematic and methodological recording of all the observations and information. After recording the preliminary information, clinical examination will be carried out on a dental chair under standard operating protocol. Patients allocated to Group I will be treated with Photobiomodulation, Group II with Cryo-Anaesthesia, and Group III with Topical Anaesthesia Gel. The procedure will be carried out in approximately 5 minutes for each patient in all the three followed by the administration of local anaesthesia. Objective pain will be assessed by a trained pediatric dentist, who will be blinded during the intervention, using Sound, Eye, Body Movement (SEM) Scale during local anaesthesia administration. Subjective pain will be assessed using self-administered Wong–Baker Faces Pain Rating Scale immediately after local anaesthesia administration. Further necessary dental treatment will be provided following standard operating protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 8-12 years of age.
- •Children requiring dental treatment under inferior alveolar nerve block technique.
- •Children classified as positive and definitely positive on Frankl’s behaviour rating scale.
- •Parents and patients who willingly give informed consent and assent respectively.
排除标准
- •Parents/ patients who do not give their consent/ assent respectively.
- •Children experiencing local inflammation or tenderness at the injection site.
- •Children with systemic conditions or special health care needs.
- •Children classified as negative and definitely negative on Frankl’s behaviour rating scale.
结局指标
主要结局
Evaluation of Reduction in Pain Perception during Local Anaesthesia Administration using Photobiomodulation, Cryo-Anaesthesia and Topical Anaesthesia Gel in Children Aged 8-12 Years.
时间窗: Baseline and Post-operative
次要结局
- Comparing the Reduction in Pain Perception during Local Anaesthesia Administration using Photobiomodulation, Cryo-Anaesthesia & Topical Anaesthesia Gel in Children Aged 8-12 Years.(Baseline & post operative)
研究者
Dr Aishwarya Arunkumar Patil
KAHERs KLE Vishwanath Katti Institute of Dental Sciences