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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 34
- Primary Endpoint
- wound healing
Study Overview
Brief Summary
Does the use of low level laser (LLL) after surgical correction of cleft palate improve healing and decrease incidence of oronasal fistula?
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
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.
Eligibility Criteria
- Ages
- 6 Months to 18 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: between 6 to 18 months of age
- •Patient has isolated cleft palate
Exclusion Criteria
- •Systemic disease
- •Hematological disorder
Arms & Interventions
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
Intervention: 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
Intervention: low level laser (Other)
Outcomes
Primary Outcomes
wound healing
Time Frame: 2 years
healing by days to closure
Secondary Outcomes
- occurrence of oronasal fistula(3 months)
Investigators
El noman Mohamed Kamal El shafie
Principal Investigator
Cairo University