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

NCT03688737 | Unknown DMC

• 1 other identifier: 172162009
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cleft Palate Children; Laser

Keywords

low level laser , cleft palate , healing

Outcome Measures

Primary Outcomes (1)

• wound healing

  healing by days to closure

  2 years

Secondary Outcomes (1)

• occurrence of oronasal fistula

  3 months

Study Arms (2)

control group

PLACEBO COMPARATOR

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

study group

ACTIVE COMPARATOR

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

Interventions

low level laser OTHER

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

Also known as: wavelength (λ) of (600 nm to 700nm)

study group

placebo OTHER

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

control group

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: between 6 to 18 months of age
• Patient has isolated cleft palate

You may not qualify if:

• Systemic disease
• Hematological disorder

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Cleft Palate

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

El noman MK El shafie, M.Sc.

CONTACT

002001063999203; nomanmust@yahoo.com

Basma GM Moussa, Prof

CONTACT

002001005644098

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share