The Effect of Adjunctive Use of Low Level Laser (LLL) After Surgical Correction of Isolated Cleft Palate Versus Surgical Correction Without LLL in Healing Process
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 主要终点
- wound healing
研究概览
简要总结
Does the use of low level laser (LLL) after surgical correction of cleft palate improve healing and decrease incidence of oronasal fistula?
详细描述
Primary objective:
To evaluate the effect of adjunctive use of LLL after surgical correction of cleft palate in improving healing among children with cleft palate Secondary objectives To evaluate the effect of adjunctive use of LLL after surgical correction of cleft palate in decreasing incidence of oronasal fistula after surgical repair among children with cleft palate Study group: Will use LLL after surgical correction of cleft palate at day of surgery, 1st day and 3rd day Control group: Surgical correction of cleft palate without Adjunctive use of LLL
Inclusion criteria:
- Age: between 6 to 18 months of age
- Patient has isolated cleft palate
Exclusion criteria:
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
- Single (Participant)
盲法说明
Single blinded study. Blinding to the patient will be ensured by masking the instruments during the follow up. The patient will be informed of the steps of the follow up (as mentioned in the consent form) without getting into details of the method of follow up.
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: between 6 to 18 months of age
- •Patient has isolated cleft palate
排除标准
- •Systemic disease
- •Hematological disorder
研究组 & 干预措施
control group
A) Control group:
Has Surgical procedures "von Langenbeck technique " to repair cleft palate and will come for follow up visit at day of surgery, 1st day and 3rd day for placebo device like LLL and come for follow up visits at 5th day ,2 weeks, month and 3 months postoperative
干预措施: placebo (Other)
study group
B) Study group:
This group will be subjected to the same surgical procedure "von Langenbeck technique "to repair cleft palate but low level laser Therapy will be at day of surgery, 1st day and 3rd day and come for follow up visits at 5th day ,2 weeks, month and 3 months postoperative
干预措施: low level laser (Other)
结局指标
主要结局
wound healing
时间窗: 2 years
healing by days to closure
次要结局
- occurrence of oronasal fistula(3 months)
研究者
El noman Mohamed Kamal El shafie
Principal Investigator
Cairo University