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

Primary Purpose

Cleft Palate Children, Laser

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low level laser
placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate Children focused on measuring low level laser , cleft palate , healing

Eligibility Criteria

6 Months - 18 Months (Child)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    control group

    study group

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    wound healing
    healing by days to closure

    Secondary Outcome Measures

    occurrence of oronasal fistula
    Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink

    Full Information

    First Posted
    September 24, 2018
    Last Updated
    September 26, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03688737
    Brief Title
    Low Level Laser in Isolated Cleft Palate Repair Versus Surgical Correction Without LLL in Healing Process
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2018 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: Age: between 6 to 18 months of age Patient has isolated cleft palate Exclusion criteria: Systemic disease Hematological disorder Outcome: Outcome measure (s) (1ry, 2ry) 1ry: healing assessment 2ry: occurrence of oronasal fistula

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cleft Palate Children, Laser
    Keywords
    low level laser , cleft palate , healing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
    Masking
    Participant
    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.
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm 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
    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    low level laser
    Other Intervention Name(s)
    wavelength (λ) of (600 nm to 700nm)
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    placebo like device as it like low level laser device shape but with no effect to blind the intervention
    Primary Outcome Measure Information:
    Title
    wound healing
    Description
    healing by days to closure
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    occurrence of oronasal fistula
    Description
    Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age: between 6 to 18 months of age Patient has isolated cleft palate Exclusion Criteria: Systemic disease Hematological disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    El noman MK El shafie, M.Sc.
    Phone
    002001063999203
    Email
    nomanmust@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Basma GM Moussa, Prof
    Phone
    002001005644098

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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