Unilateral Cleft LipNCT05334602
The Effect of Use of Dermal Fat Graft as a Barrier Membrane
A study testing Addition of dermal fat graft as protection over bone graft in people with Unilateral Cleft Lip, run by Ain Shams University at 1 site in Egypt.
Trial summary
a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- Addition of dermal fat graft as protection over bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Unilateral Cleft Lip
- Being tested
- Addition of dermal fat graft as protection over bone graft
- Keywords
- Alveolar cleft grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of dermal fat graft as protection over bone graftProcedure or surgery
A barrier membrane
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption Receives: Procedure: Addition of dermal fat graft as protection over bone graft |
| control group | No intervention | Conventional procedure of alveolar cleft grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oronasal fistula
assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Mar 2019
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cleft LipStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Ain Shams University
- Investigators
- Marwa EL Kassaby, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334602
- Sponsor's protocol ID
- 4.12.2022
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: RCT conducted to assess the effect of adding fat over bone graft in order to protect the bone from resorption
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Use of Dermal Fat Graft as a Barrier Membrane in Unilateral Alveolar Cleft Grafting. (A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05334602
- Acronym / sponsor ID
- 4.12.2022
- Conditions
- Unilateral Cleft Lip
- Keywords
- Alveolar cleft grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: Addition of dermal fat graft as protection over bone graftDermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption |
| control group | No intervention | –Conventional procedure of alveolar cleft grafting |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addition of dermal fat graft as protection over bone graftA barrier membrane | Procedure or surgery | study group |
Primary outcome
Incidence of oronasal fistula
Time frame: 6 months
assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No. RCT conducted to assess the effect of adding fat over bone graft in order to protect the bone from resorption
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa EL Kassaby study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of dermal fat graft as protection over bone graft in people with Unilateral Cleft Lip, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oronasal fistula (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.