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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688737
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
El noman Mohamed Kamal El shafie, Cairo University

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

Condition or disease Intervention/treatment Phase
Cleft Palate Children Laser Other: low level laser Other: placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
Masking: Single (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.
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: control group

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

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

Active Comparator: study group

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

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 Name: wavelength (λ) of (600 nm to 700nm)




Primary Outcome Measures :
  1. wound healing [ Time Frame: 2 years ]
    healing by days to closure


Secondary Outcome Measures :
  1. occurrence of oronasal fistula [ Time Frame: 3 months ]
    Postoperative complications; mainly oronasal fistula by; clinical observation: inspection, clinical signs: regurgitation of food or drink



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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688737


Contacts
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Contact: El noman MK El shafie, M.Sc. 002001063999203 nomanmust@yahoo.com
Contact: Basma GM Moussa, Prof 002001005644098

Sponsors and Collaborators
Cairo University
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Responsible Party: El noman Mohamed Kamal El shafie, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03688737    
Other Study ID Numbers: 172162009
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El noman Mohamed Kamal El shafie, Cairo University:
low level laser , cleft palate , healing
Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities