Low Level Laser in Isolated Cleft Palate Repair Versus Surgical Correction Without LLL in Healing Process

Study Overview
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Brief Summary
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Does the use of low level laser (LLL) after surgical correction of cleft palate improve healing and decrease incidence of oronasal fistula?

Detailed Description
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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: Systemic disease Hematological disorder Outcome: Outcome measure (s) (1ry, 2ry) 1ry: healing assessment 2ry: occurrence of oronasal fistula

Official Title
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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

Conditions
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Cleft Palate Children, Laser

Intervention / Treatment
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* Other: low level laser
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: between 6 to 18 months of age Patient has isolated cleft palate Exclusion Criteria: Systemic disease Hematological disorder

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>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 | Other: placebo<br>* placebo like device as it like low level laser device shape but with no effect to blind the intervention<br>|
| Active Comparator: study group<br>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 | Other: low level laser<br>* 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<br>* Other names: wavelength (λ) of (600 nm to 700nm);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing | healing by days to closure | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of oronasal fistula | Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low level laser , cleft palate , healing