Evaluation of Post Operative Pain with and without Photobiomodulation therapy in Children Aged 4 to 8 Years Undergoing Pulpectomy in Primary Molars:A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Photobiomodulation therapy may reduce post operative pain following pulpectomy in primary molars in children aged 4 to 8 years
研究概览
简要总结
Post-endodontic pain is a common concern in pediatric dentistry, often exacerbated by debris extrusion and anxiety, especially in primary teeth. Photo biomodulation therapy (PBMT) has emerged as a safe, non-invasive method to reduce pain and promote healing by modulating cellular processes and reducing inflammation. This study evaluates the efficacy of PBMT in managing postoperative pain in children aged 4–9 years undergoing pulpectomy, comparing pain levels at 24, 48, and 72 hours using the Wong-Baker Faces Pain Scale. Results aim to enhance pain management in pediatric endodontics. This study aims to evaluate post operative pain with and without Photo biomodulation therapy in children aged 4 to 8 years undergoing pulpectomy in primary molars. The objective of the study is to evaluate and compare post operative pain with and without Photo biomodulation therapy in children aged 4 to 8 years undergoing pulpectomy in primary molars.
This is a double arm, parallel group randomized clinical trial evaluating the post operative pain with and without Photo biomodulation therapy in children aged 4 to 8 years undergoing pulpectomy in primary molars. The study will be conducted at the Department of Pediatric and Preventive Dentistry, KAHER’S KLE V. K Institute of Dental Sciences, Belagavi and will include 50 children requiring pulpectomy procedure. The treatment will be carried out under standard operating procedure by Principal Investigator. Patients allotted to group I will be treated with Pulpectomy alone and group II will be treated with Pulpectomy + Photo biomodulation (980nm). Post-operative pain assessment at 24, 48 and 72 hours in both groups using self-administered Wong Baker Faces Pain Rating scale will be done. Further necessary treatment will be provided following standard operating protocol. The expected outcome of study is that Photo biomodulation therapy may reduce post operative pain following pulpectomy in primary molars in children aged 4 to 8 years.
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
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to undergo treatment Children in the age group of 4 to 8 years Primary molars with minimum two third of root length remaining,Tooth with history of spontaneous pain Radiographic evaluation of tooth showing radiolucency involving enamel, dentin, and pulp.
排除标准
- •Clinically non-restorable teeth.
- •Teeth exhibiting more than one third of physiological/ pathologic root resorption.
- •Children with special health care needs and systemic diseases.
- •Previously endodontically treated teeth.
- •• Teeth with draining sinus or fistula.
结局指标
主要结局
Photobiomodulation therapy may reduce post operative pain following pulpectomy in primary molars in children aged 4 to 8 years
时间窗: Post operative pain assessment at 24 , 48, and 72 hours using Wong Baker Pain Faces Rating Scale rating 0 to 10 where 0 is no hurt and 10 is hurts worst
次要结局
- Photo biomodulation therapy may reduce the need of analgesic following pulpectomy in primary molars in children aged 4 to 8 years(Analgesic taken if any will be noted at 24 hr., 42 hr., 72 hr.)
研究者
Dr Akanksha Dumbare
KLE V.K Institute of Dental Sciences