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

Laser Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03688737
• Other study ID #: 172162009
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Cairo University
• Contact: El noman MK El shafie, M.Sc.
• Phone: 002001063999203
• Email: nomanmust[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate
• Cleft Palate Children
• Laser

Intervention

Other:
• low level laser
LLLT with wavelength (?) 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
placebo like device as it like low level laser device shape but with no effect to blind the intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing	healing by days to closure	2 years
Secondary	occurrence of oronasal fistula	Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink	3 months