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

Cairo University (CU)

Status: Unknown

Conditions: Cleft Palate Children; Laser

Treatments: Other: placebo; Other: low level laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03688737

172162009

Details and patient eligibility

About

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

Full 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

Enrollment: 34 estimated patients

Sex: All

Ages: 6 to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

study group

Active Comparator group

Description:

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

Treatment:

Other: low level laser