Bone Facial BoneNCT06455176
Delayed Secondary Reconstruction of Alveolar Clefts Using Autogenous Symphyseal Particulate Bone Versus Iliac Cancellous Bone: A Randomized Clinical Trial
A study testing alveolar cleft Grafting from the symphysis and alveolar cleft Grafting from the iliac cancellous bone in people with Bone Facial Bone, run by Cairo University.
Trial summary
Patients with alveolar clefts whose ages are after 12 years (after eruption of all permanent dentition) were recruited and treated either by particulate bone grafting from the symphysis or from the anterior iliac crest Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Bone Facial Bone
- What is being tested?
- alveolar cleft Grafting from the symphysis and alveolar cleft Grafting from the iliac cancellous bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2025
- 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- cleft alveolus patients of both genders after eruption of all permanent dentition
Who cannot join
- previous failed repairs of alveolar clefts and bone metabolic diseases
About this study
Patients with alveolar clefts whose ages are after 12 years (after eruption of all permanent dentition) were recruited and treated either by particulate bone grafting from the symphysis or from the anterior iliac crest
- Conditions
- Bone Facial Bone
- Being tested
- alveolar cleft Grafting from the symphysis, alveolar cleft Grafting from the iliac cancellous bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar cleft Grafting from the symphysisProcedure or surgery
grafting using particulate bone from the symphysis
alveolar cleft Grafting from the iliac cancellous boneProcedure or surgery
grafting using iliac cancellous bone
| Study group | Role | What they receive |
|---|---|---|
| Symphyseal bone group | Active comparator | Not described Receives: Procedure: alveolar cleft Grafting from the symphysis |
| iliac cancellous bone group | Active comparator | Not described Receives: Procedure: alveolar cleft Grafting from the iliac cancellous bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone volume in the reconstructed cleft site
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Facial BoneStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shawky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455176
- Sponsor's protocol ID
- Cairo uni research
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Secondary Reconstruction of Alveolar Clefts Using Autogenous Symphyseal Particulate Bone Versus Iliac Cancellous Bone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06455176
- Acronym / sponsor ID
- Cairo uni research
- Conditions
- Bone Facial Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Jun 2024 (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.
Patients with alveolar clefts whose ages are after 12 years (after eruption of all permanent dentition) were recruited and treated either by particulate bone grafting from the symphysis or from the anterior iliac crest
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symphyseal bone group | Active comparator | Procedure: alveolar cleft Grafting from the symphysis |
| iliac cancellous bone group | Active comparator | Procedure: alveolar cleft Grafting from the iliac cancellous bone |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- cleft alveolus patients of both genders after eruption of all permanent dentition
Key exclusion criteria (1 listed)
- previous failed repairs of alveolar clefts and bone metabolic diseases
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 |
|---|---|---|
| alveolar cleft Grafting from the symphysisgrafting using particulate bone from the symphysis | Procedure or surgery | Symphyseal bone group |
| alveolar cleft Grafting from the iliac cancellous bonegrafting using iliac cancellous bone | Procedure or surgery | iliac cancellous bone group |
Primary outcome
bone volume in the reconstructed cleft site
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing alveolar cleft Grafting from the symphysis and alveolar cleft Grafting from the iliac cancellous bone in people with Bone Facial Bone, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
bone volume in the reconstructed cleft site (time frame: six 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 12 Jun 2024.