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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03688737

Enrollment

Registered

2018-09-28

Start date

2018-10-31

Completion date

2020-12-31

Last updated

2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate Children, Laser

Keywords

low level laser , cleft palate , healing

Brief 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

Interventions

OTHERlow 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

OTHERplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
wound healing	2 years	healing by days to closure

Secondary

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

Contacts

Primary ContactEl noman MK El shafie, M.Sc.

nomanmust@yahoo.com002001063999203

Backup ContactBasma GM Moussa, Prof

002001005644098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026