Effect of Low-Level Laser Therapy on Wound Healing and Post-extraction Pain Management of Primary Molars. (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- wound healing
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of low-level laser therapy on wound healing of primary molar teeth extraction. in children aged 5-8 years with bilateral primary molars indicated for extraction. The main questions it aims to answer are:
- does low-level laser therapy affect wound healing of primary molar teeth extraction?
- does of low-level laser therapy affect post-extraction pain management of primary molar.? Researchers will compare placebo group (Sham side) to Intervention side ( split mouth design).
Participants will be subjected to low level laser and post-extraction instructions in the intervention side, while the placebo side will receive post-extraction instructions only, participants will come for follow up on days 3, and 7 after extraction, they will answer self-reported questionnare related to post-extraction pain , wound healing will also be measured from photographs of the extraction site using Image J soft-ware
详细描述
The goal of this clinical trial is to evaluate the effect of low-level laser therapy on wound healing of primary molar teeth extraction. in children aged 5-8 years with bilateral primary molars indicated for extraction. this is a split mouth randomized controlled clinical trial.
Each participant will have one side randomly assigned to intervention using low level diode laser at a wavelength of 660nm aimed at the extraction site 1 cm away for 60 seconds in continuous emission mode. the other side will be placebo side with just the aiming beam, in both visits the participant will be given post-extraction instructions
participants will come for follow up on days 3, and 7 after extraction, they will answer an arabic self-reported questionnaire comprising 33 items that assessed pain, discomfort, analgesic consumption, daily activities, and jaw-function impairment on the night of the extraction and after 7 days, wound healing will also be measured days 3 and 7 using of the extraction site using Wound healing index by Landry, Turnbull and Howley, and wound size will be measured using Image J soft-ware from the from photographs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age range from 5 - 8 years.
- •Children free of any systemic disease or special health care need.
- •No previous extractions.
- •Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4).
- •Patients with bilateral primary molars indicated for extraction.
- •Patients whose parents will give their written consent to participate
排除标准
- •Resorption more than one third of the root length.
- •Signs of mobility.
- •History of allergy to local anesthesia.
- •Medical History involving conditions such as prolonged bleeding, platelet disorders, hypersensitivity, allergic reactions to pain relievers and contradictions to laser therapy.
- •Acute pain.
研究组 & 干预措施
intervention
intervention arm using low-level laser therapy photobiomodulation
干预措施: Low Level Laser Therapy (Device)
placebo (Sham)
sham (placebo) arm
干预措施: Placebo plus Treatment As Usual (Behavioral)
结局指标
主要结局
wound healing
时间窗: days 3 and 7
wound healing will be measured using using the Landry, Turnbull and Howley wound healing index , with minimum score 1 and maximum score 5 , as the score inceases this means better healing.
post-extraction pain (PEP)
时间窗: days 3 and 7
post- extraction pain will be measured using the Arabic Version of a self-reported Questionnaire Assessing Pain, Discomfort and Related Jaw Function Impairment in Children on the night of extraction and on day 7 using WONG-BAKER FACES pain scale with 0 minimum and 10 maximum value. the higher the value the worse the outcome.
wound size measurements
时间窗: days 3 and 7
wound size measurments immediately after the extraction, and at days 3 and using Image J software
次要结局
未报告次要终点