NCT05334602

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

April 12, 2022

Last Update Submit

April 12, 2022

Conditions

Unilateral Cleft Lip

Keywords

Alveolar cleft grafting

Outcome Measures

Primary Outcomes (1)

  • Incidence of oronasal fistula

    assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically

    6 months

Study Arms (2)

study group

EXPERIMENTAL

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

control group

NO INTERVENTION

Conventional procedure of alveolar cleft grafting

Interventions

Addition of dermal fat graft as protection over bone graftPROCEDURE

A barrier membrane

study group

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams University

Cairo, 11757, Egypt

Location

Study Officials

  • Marwa EL Kassaby

    Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 19, 2022

Study Start

March 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

RCT conducted to assess the effect of adding fat over bone graft in order to protect the bone from resorption

Locations

EG(1)