Alveolar CleftNCT06855875
Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft
A study testing autogenous tooth graft combined with bovine bone and bovine bone in people with Alveolar Cleft, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is evaluation of autogenous tooth-derived graft combined with bovine bone for surgical repair of unilateral alveolar cleft . Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- autogenous tooth graft combined with bovine bone and bovine bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to 28 May 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with unilateral alveolar clefts requiring repair.
- patients free from any systemic disease that may affect normal healing of bone.
- patients in an age 7y up to 14 y.
- patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth\& non functional tooth in the study group.
Who cannot join
- Bilateral alveolar clefts.
- Immunocompromized patients.
- Syndromic patients.
- Patients have good full set of teeth, cannot be sacrified in study group
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is evaluation of autogenous tooth-derived graft combined with bovine bone for surgical repair of unilateral alveolar cleft .
Read the detailed description
Decalcified dentin graft is thought to be a good graft material that can substitute existing autogenous bone graft materials. It can be easily and readily available, with minimal risk of infection, minimal donor site morbidity as no vital bone is sacrificed, it can be easily shaped to fit into the bony defect and it can be used as block or in powder forms, the hypothesis is to evaluate the biological and the physical properties of both and autogenous tooth derived graft and bovine bone to increase the quality and density of newly formed bone in alveolar cleft grafting
Criteria of patient selection:
Inclusion Criteria:
Patients with unilateral alveolar clefts requiring repair. patients free from any systemic disease that may affect normal healing of bone. patients in an age 7y up to 14 y. patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth\& non functional tooth in the study group.
Exclusion criteria:
Bilateral alveolar clefts. Immunocompromized patients. Syndromic patients. Patients have good full set of teeth, cannot be sacrified in study group The patients grouping with unilateral alveolar cleft will be classified into two equal groups according to the grafting material used for alveolar cleft repair.
Study Group:
This will include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .
Control Group:
This will include 8 patients in whom alveolar cleft will be repaired using bovine bone .
- Conditions
- Alveolar Cleft
- Being tested
- autogenous tooth graft combined with bovine bone, bovine bone
- Keywords
- teeth derived graft, bovine bone, alveolar cleft grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous tooth graft combined with bovine boneProcedure or surgery
unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .
bovine boneProcedure or surgery
unilateral alveolar cleft which will be repaired using bovine bone .
| Study group | Role | What they receive |
|---|---|---|
| autogenous tooth graft combined with bovine bone | Experimental | This include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone . Receives: Procedure: autogenous tooth graft combined with bovine bone |
| bovine bone | Experimental | This include 8 patients in whom alveolar cleft will be repaired using bovine bone . Receives: Procedure: bovine bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
0 representing no pain and 10 representing the highest level of pain
Measured: 1 month
inflammation score scale
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
Measured: 1 month
Secondary outcomes (1)
bone mineral density
density of bone to measure (D1,D2,D3,D4) from 150 HU to 1250HU
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 posted4 Mar 2025
- Study start10 Aug 2024
- Primary completion10 Nov 2024
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CleftStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Taha Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855875
- Sponsor's protocol ID
- OS-4-23-2
- Status last verified
- Jun 2025
- First submitted
- 21 Feb 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft
- ClinicalTrials.gov ID
- NCT06855875
- Acronym / sponsor ID
- OS-4-23-2
- Conditions
- Alveolar Cleft
- Keywords
- teeth derived graft, bovine bone, alveolar cleft grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 4 Mar 2025 (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.
The aim of this study is evaluation of autogenous tooth-derived graft combined with bovine bone for surgical repair of unilateral alveolar cleft .
Detailed description
Decalcified dentin graft is thought to be a good graft material that can substitute existing autogenous bone graft materials. It can be easily and readily available, with minimal risk of infection, minimal donor site morbidity as no vital bone is sacrificed, it can be easily shaped to fit into the bony defect and it can be used as block or in powder forms, the hypothesis is to evaluate the biological and the physical properties of both and autogenous tooth derived graft and bovine bone to increase the quality and density of newly formed bone in alveolar cleft grafting
Criteria of patient selection:
Inclusion Criteria:
Patients with unilateral alveolar clefts requiring repair. patients free from any systemic disease that may affect normal healing of bone. patients in an age 7y up to 14 y. patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth\& non functional tooth in the study group.
Exclusion criteria:
Bilateral alveolar clefts. Immunocompromized patients. Syndromic patients. Patients have good full set of teeth, cannot be sacrified in study group The patients grouping with unilateral alveolar cleft will be classified into two equal groups according to the grafting material used for alveolar cleft repair.
Study Group:
This will include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .
Control Group:
This will include 8 patients in whom alveolar cleft will be repaired using bovine bone .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autogenous tooth graft combined with bovine bone | Experimental | Procedure: autogenous tooth graft combined with bovine boneThis include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone . |
| bovine bone | Experimental | Procedure: bovine boneThis include 8 patients in whom alveolar cleft will be repaired using bovine bone . |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with unilateral alveolar clefts requiring repair.
- patients free from any systemic disease that may affect normal healing of bone.
- patients in an age 7y up to 14 y.
- patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth\& non functional tooth in the study group.
Key exclusion criteria (4 listed)
- Bilateral alveolar clefts.
- Immunocompromized patients.
- Syndromic patients.
- Patients have good full set of teeth, cannot be sacrified in study group
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 |
|---|---|---|
| autogenous tooth graft combined with bovine boneunilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone . | Procedure or surgery | autogenous tooth graft combined with bovine bone |
| bovine boneunilateral alveolar cleft which will be repaired using bovine bone . | Procedure or surgery | bovine bone |
Primary outcome
visual analogue scale
Time frame: 1 month
0 representing no pain and 10 representing the highest level of pain
inflammation score scale
Time frame: 1 month
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
1 secondary outcome
bone mineral density
Time frame: 6 months
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 1 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autogenous tooth graft combined with bovine bone and bovine bone in people with Alveolar Cleft, run by Tanta 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 4 inclusion and 4 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 1 Jul 2025. 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?
visual analogue scale (time frame: 1 month). The study lists 2 primary outcomes in all. 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 1 Jul 2025.