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

Unilateral Cleft Lip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334602
• Other study ID #: 4.12.2022
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Unilateral Cleft Lip

Intervention

Procedure:
• Addition of dermal fat graft as protection over bone graft
A barrier membrane

Locations

Country	Name	City	State
Egypt	Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of oronasal fistula	assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically	6 months