Unilateral Alveolar Cleft of MaxillaNCT07066293
Sticky Bone Grafting With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft
A study testing Unilateral alveolar cleft repair in people with Unilateral Alveolar Cleft of Maxilla, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate using Sticky Bone grafting combined with concentrated growth factor membrane for repair of unilateral alveolar cleft. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Unilateral Alveolar Cleft of Maxilla
- What is being tested?
- Unilateral alveolar cleft repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 2 Oct 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 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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 at an age older than 12 years
Who cannot join
- Bilateral alveolar clefts.
- Immunocompromised patients.
- Syndromic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Using Sticky Bone Grafting Combined With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft
The aim of this study is to evaluate using Sticky Bone grafting combined with concentrated growth factor membrane for repair of unilateral alveolar cleft.
Read the detailed description
This study will be carried out on ten patients with unilateral alveolar clefts, The patients will be recieved, clinically\& radiographically examined and managed at Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation:
Clinical evaluation will include presence of oronasal fistulas, nasal regurgitation and Presence of erupting teeth in cleft. .Preoperative cone beam computed tomography (CBCT) scans will be analyzed to measure alveolar cleft dimensions and the total cleft defect volume will be calculated.
Surgical technique:
Under general anesthesia, mucoperiosteal flaps will be raised along the cleft margins, exposing the defect. The nasal lining will be sutured with 4/0 Vicryl, followed by the application of a concentrated growth factor (CGF) membrane to cover the nasal mucosa. The sticky bone graft will be packed tightly into the cleft, ensuring complete defect filling. A CGF membrane will be then placed over the graft to enhance stability and healing. The flaps will be sutured using tension-free interrupted 3/0 Vicryl sutures to ensure full coverage of the graft.
Postoperative evaluation:
The patients will be evaluated over a nine-months follow-up period clinically at intervals of 1st \& 2nd weeks, then 1st ,3rd and 9th months for healing parameters such as infection, wound dehiscence, recurrence of oronasal fistulas, nasal regurgitation and graft exposure \& radiographically by using CBCT for assessing graft volume, bone mineral density immediate, 3rd \& 9th months postoperatively.
- Conditions
- Unilateral Alveolar Cleft of Maxilla
- Being tested
- Unilateral alveolar cleft repair
- Keywords
- alveolar cleft, sticky bone, concentrated growth factor, volumetric assessment, bone mineral density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral alveolar cleft repairProcedure or surgery
10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane
| Study group | Role | What they receive |
|---|---|---|
| Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft | Experimental | This will include 10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane Receives: Procedure: Unilateral alveolar cleft repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation
mild, moderate, severe
Measured: 1 month
nasal regurgitation
Yes or No
Measured: 1 month
fistula recurrence
positive or negative
Measured: 1 month
bone graft volume
soft ware
Measured: 1 month
bone mineral density
soft ware
Measured: 1 month
Secondary outcomes (2)
bone graft volume
soft ware
Measured: 9 months
bone mineral density
soft ware
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Nov 2022
- Primary completion12 Feb 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Alveolar Cleft of MaxillaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Nashaat Breshah, Tanta University
- Investigators
- Omnia M Saber, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMohamed S Khedr, Prof, Principal investigator, Faculty of Dentistry, Tanta University, EgyptAhmed M Elshareef, Ass prof, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMaram N Breshah, Lecturer, Principal investigator, Faculty of Dentistry, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066293
- Sponsor's protocol ID
- #R-OS-11-22-2
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Using Sticky Bone Grafting Combined With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft
- ClinicalTrials.gov ID
- NCT07066293
- Acronym / sponsor ID
- #R-OS-11-22-2
- Conditions
- Unilateral Alveolar Cleft of Maxilla
- Keywords
- alveolar cleft, sticky bone, concentrated growth factor, volumetric assessment, bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 15 Jul 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 to evaluate using Sticky Bone grafting combined with concentrated growth factor membrane for repair of unilateral alveolar cleft.
Detailed description
This study will be carried out on ten patients with unilateral alveolar clefts, The patients will be recieved, clinically\& radiographically examined and managed at Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation:
Clinical evaluation will include presence of oronasal fistulas, nasal regurgitation and Presence of erupting teeth in cleft. .Preoperative cone beam computed tomography (CBCT) scans will be analyzed to measure alveolar cleft dimensions and the total cleft defect volume will be calculated.
Surgical technique:
Under general anesthesia, mucoperiosteal flaps will be raised along the cleft margins, exposing the defect. The nasal lining will be sutured with 4/0 Vicryl, followed by the application of a concentrated growth factor (CGF) membrane to cover the nasal mucosa. The sticky bone graft will be packed tightly into the cleft, ensuring complete defect filling. A CGF membrane will be then placed over the graft to enhance stability and healing. The flaps will be sutured using tension-free interrupted 3/0 Vicryl sutures to ensure full coverage of the graft.
Postoperative evaluation:
The patients will be evaluated over a nine-months follow-up period clinically at intervals of 1st \& 2nd weeks, then 1st ,3rd and 9th months for healing parameters such as infection, wound dehiscence, recurrence of oronasal fistulas, nasal regurgitation and graft exposure \& radiographically by using CBCT for assessing graft volume, bone mineral density immediate, 3rd \& 9th months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft | Experimental | Procedure: Unilateral alveolar cleft repairThis will include 10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with unilateral alveolar clefts requiring repair.
- patients free from any systemic disease that may affect normal healing of bone.
- patients at an age older than 12 years
Key exclusion criteria (3 listed)
- Bilateral alveolar clefts.
- Immunocompromised patients.
- Syndromic patients.
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 |
|---|---|---|
| Unilateral alveolar cleft repair10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane | Procedure or surgery | Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft |
Primary outcome
inflammation
Time frame: 1 month
mild, moderate, severe
nasal regurgitation
Time frame: 1 month
Yes or No
fistula recurrence
Time frame: 1 month
positive or negative
bone graft volume
Time frame: 1 month
soft ware
bone mineral density
Time frame: 1 month
soft ware
2 secondary outcomes
bone graft volume
Time frame: 9 months
bone mineral density
Time frame: 9 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 3 Feb 2026.
- Individual participant dataSharing planned: No
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.
Omnia M Saber principal investigator
Faculty of Dentistry, Tanta University, Egypt
Mohamed S Khedr, Prof principal investigator
Faculty of Dentistry, Tanta University, Egypt
Ahmed M Elshareef, Ass prof principal investigator
Faculty of Dentistry, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral alveolar cleft repair in people with Unilateral Alveolar Cleft of Maxilla, 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 3 inclusion and 3 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 3 Feb 2026. 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?
inflammation (time frame: 1 month). The study lists 5 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 3 Feb 2026.