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

NCT03688737 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-09-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2020-01-31
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688737 on ClinicalTrials.gov