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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05334602
Enrollment
40
Registered
2022-04-19
Start date
2019-03-01
Completion date
2022-03-01
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Cleft Lip

Keywords

Alveolar cleft grafting

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.

Interventions

PROCEDUREAddition of dermal fat graft as protection over bone graft

A barrier membrane

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double blinded

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of oronasal fistula6 monthsassessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026