Does the use of low level laser (LLL) after surgical correction of cleft palate improve healing and decrease incidence of oronasal fistula?
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: 1. Age: between 6 to 18 months of age 2. Patient has isolated cleft palate Exclusion criteria: 1. Systemic disease 2. Hematological disorder Outcome: Outcome measure (s) (1ry, 2ry) 1ry: healing assessment 2ry: occurrence of oronasal fistula
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
LLLT with wavelength (λ) of (600 nm to 700nm), The laser will be held 1 cm away from the surface of the target tissue, the irradiated area is 0,5 cm2.The area of impact is the surgical wound zone and the neighboring 0,5-1,0 cm of the adjacent oral mucosa for 1min and 22sec, 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
placebo like device as it like low level laser device shape but with no effect to blind the intervention
wound healing
healing by days to closure
Time frame: 2 years
occurrence of oronasal fistula
Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink
Time frame: 3 months
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