NCT03688737

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

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: 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

Conditions

• Cleft Palate Children
• Laser

Interventions

Type	Name	Description
OTHER	low level laser	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
OTHER	placebo	placebo like device as it like low level laser device shape but with no effect to blind the intervention

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-01-01
• Completion: 2020-12-01
• First posted: 2018-09-28
• Last updated: 2018-09-28