The Effect of Use of Dermal Fat Graft as a Barrier Membrane

The Effect of Use of Dermal Fat Graft as a Barrier Membrane in Unilateral Alveolar Cleft Grafting. (A Randomized Clinical Trial

a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone

Study Overview

• Status: Completed
• Conditions: Unilateral Cleft Lip
• Intervention / Treatment: Procedure: Addition of dermal fat graft as protection over bone graft

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11757
    • ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption	Procedure: Addition of dermal fat graft as protection over bone graft; A barrier membrane
No Intervention: control group; Conventional procedure of alveolar cleft grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of oronasal fistula	assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Marwa EL Kassaby, ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Alveolar cleft grafting
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 4.12.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: RCT conducted to assess the effect of adding fat over bone graft in order to protect the bone from resorption

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No