Back to resultsThe Effect of Use of Dermal Fat Graft as a Barrier Membrane
Primary Purpose
Unilateral Cleft Lip
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Addition of dermal fat graft as protection over bone graft
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Cleft Lip focused on measuring Alveolar cleft grafting
Eligibility Criteria
Inclusion Criteria:
Patients having age range of 8-14ys who performed for 2ry alveolar cleft grafting at the CCC using adipose fat graft in conjunction with ACBG Boys or girls. Unilateral or bilateral cleft alveolus. Accepts Healthy Volunteers has not been entered.
Exclusion Criteria:
Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.
Sites / Locations
- Ain shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group
control group
Arm Description
Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption
Conventional procedure of alveolar cleft grafting
Outcomes
Primary Outcome Measures
Incidence of oronasal fistula
assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334602
Brief Title
The Effect of Use of Dermal Fat Graft as a Barrier Membrane
Official Title
The Effect of Use of Dermal Fat Graft as a Barrier Membrane in Unilateral Alveolar Cleft Grafting. (A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone
Detailed Description
The study has two group in which the study will have in addition to the conventional bone grafting addition of dermal fat graft to protect the bone. The control will have just normal graft
The results are assessed using computed tomography to assess the quality of the grafted bone.
The Chisquare test was used to asses the results significance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cleft Lip
Keywords
Alveolar cleft grafting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption
Arm Title
control group
Arm Type
No Intervention
Arm Description
Conventional procedure of alveolar cleft grafting
Intervention Type
Procedure
Intervention Name(s)
Addition of dermal fat graft as protection over bone graft
Intervention Description
A barrier membrane
Primary Outcome Measure Information:
Title
Incidence of oronasal fistula
Description
assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients having age range of 8-14ys who performed for 2ry alveolar cleft grafting at the CCC using adipose fat graft in conjunction with ACBG Boys or girls. Unilateral or bilateral cleft alveolus. Accepts Healthy Volunteers has not been entered.
Exclusion Criteria:
Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa EL Kassaby
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain shams University
City
Cairo
ZIP/Postal Code
11757
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
RCT conducted to assess the effect of adding fat over bone graft in order to protect the bone from resorption
Learn more about this trial
The Effect of Use of Dermal Fat Graft as a Barrier Membrane
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