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

Overview

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

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: January 2020

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

Interventions

• 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

Arms, Groups and Cohorts

• Placebo Comparator: 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
• Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

• wound healing
  • Time Frame: 2 years
  • healing by days to closure

Secondary Measures

• occurrence of oronasal fistula
  • Time Frame: 3 months
  • Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 18 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Cairo University
• Provider of Information About this Clinical Study
  • Principal Investigator: El noman Mohamed Kamal El shafie, Principal Investigator – Cairo University
• Overall Contact(s)
  • El noman MK El shafie, M.Sc., 002001063999203, nomanmust@yahoo.com