Alveolar CleftsNCT06924216
Evaluation of Using Iliac Crest With and Without Platelet-Rich Fibrin in Repair of Congenital Alveolar Cleft
A study testing alveolar bone grafting and alveolar bone grafting Plus Platelet rich fibrin in people with Alveolar Clefts and Alveolar Bone Grafting, run by Suez Canal University at 1 site in Egypt.
Trial summary
A randomized clinical trial aims to evaluate the clinical and radiographic outcomes of the repair of congenital alveolar clefts using Iliac crest graft with and without mixing with platelet-rich fibrin Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Alveolar Clefts, Alveolar Bone Grafting, Alveolar Bone Loss
- What is being tested?
- alveolar bone grafting and alveolar bone grafting Plus Platelet rich fibrin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with congenital alveolar cleft who need secondary alveolar cleft repair.
- Patients who are medically fit for surgery under general anaesthesia
Who cannot join
- ASA 4 OR ASA 5 patients
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Using Iliac Crest Graft With and Without Platelet-Rich Fibrin (PRF) in Repair of Congenital Alveolar Cleft
A randomized clinical trial aims to evaluate the clinical and radiographic outcomes of the repair of congenital alveolar clefts using Iliac crest graft with and without mixing with platelet-rich fibrin
Read the detailed description
Alveolar clefts occur in response to deviations from normal development in the growth, exposure, and fusion of the frontal eminence. The most common alveolar portion of the cleft is located between the central incisors and canines. The treatment of alveolar clefts is multidisciplinary and aimed at restoring normal ridge contour and functionality. Surgical wound closure is insufficient to repair bony defects, Additional materials are needed for these types of defects, such as bone grafts. Aim: The aim of this study is to evaluate the efficiency of using iliac crest bone graft with and without platelet-rich fibrin in repair of alveolar clefts. Methodology: This study will be conducted on 16 patients with alveolar clefts. The patients will be divided equally and randomly into 2 groups: Group 1 : 8 patients will be treated with iliac crest bone graft only (control group).Group 2: 8 patients will be treated with iliac crest bone graft with platelet-rich fibrin (study group).
- Conditions
- Alveolar Clefts, Alveolar Bone Grafting, Alveolar Bone Loss
- Being tested
- alveolar bone grafting, alveolar bone grafting Plus Platelet rich fibrin
- Keywords
- alveolar clefts, iliac crest, graft, PRF
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar bone graftingProcedure or surgery
Also called Repair of alveolar clefts
cancellous iliac crest bone will be harvested following the usual surgical procedure. For patients of group a-PRF, it was mixed with 1 cc of the supernatant previously collected, in order to obtain a cohesive bone graft, easier to manipulate.
The oral mucosal lining will be closed, and a membrane of PRF (PRF group) will be put over the suture line. The alveolar cleft will be then filled with cancellous iliac crest bone along its entire height. A new membrane of PRF will be placed over the bone graft, in order to enclose and protect it. Finally, muco-periosteal flaps will be advanced and sutured without tension over the alveolar crest
alveolar bone grafting Plus Platelet rich fibrinProcedure or surgery
Also called PRF
the PRF group: centrifugation at 1300 rpm during 5 minutes, collection of 1 cc of the supernatant, and centrifugation at 1300 rpm during 3 minutes. Careful removal of the clot and separation from the red blood cell fraction with scissors.
the Platelet-rich fibrin will be added to the surgical site mixed with the iliac crest bone graft and it will also be used as a membrane before closure of the mucoperiosteal flap
| Study group | Role | What they receive |
|---|---|---|
| with platelet-rich fibrin | Experimental | study group: the patients will be treated with iliac crest bone graft with platelet-rich fibrin Receives: Procedure: alveolar bone grafting Plus Platelet rich fibrin |
| without Platelet-rich fibrin | Active comparator | control group : the patients will be treated with iliac crest bone graft only Receives: Procedure: alveolar bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bucco-lingual thickness of the bone at the recipient site
Post-operative cone beam computed tomographic radiographs will be done using the Scanora 3DX imaging system using a CMOS flat panel detector with isotropic voxel size 133 µm. The x-ray tube that is used to scan the patients possesses a current intensity of 10 mA, 90 KVp, and a focal spot size of 0.5 mm. The scanning time is 14 seconds of pulsed exposure, resulting in an effective exposure time of 3.2 seconds to scan FOV (field of view) of 14 cm height × 16.5 cm width. The raw DICOM data set images will be imported to the On-Demand software (Cybermed, Seoul, Korea) for secondary reconstruction and image analysis.
CBCT will be performed, and linear measurements will be obtained in axial, sagittal, and coronal cuts to assess the changes in buccolingual thickness of the bone at the recipient site 3 months and 6 months post-operatively.
Measured: 3 months and 6 months postoperatively
Secondary outcomes (2)
Calculation of the volume of bone fill in the recipient site
The volume of remaining alveolar defect around the bone graft at 6 months will be measured and subtracted from the actual alveolar defect volume to calculate the volume of bone fill. The actual volume of alveolar bone graft will be represented as a percentage of bone fill of the alveolar defect volume (Preoperative alveolar Defect Volume minus Postoperative residual defect volume / Preoperative Alveolar defect volume X 100)
Measured: 6 months postoperative
wound dehiscence
Clinical evaluation for wound dehiscence immediate, 7 days, and 14 days postoperatively to detect any complications such as infection, flap dehiscence, or fistula formation. Then the percentage of cases with soft tissue complications will be calculated
Measured: immediate, 7 days and 14 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start27 Apr 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar CleftsStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed S Hamed, professor, Study director, Suez Canal UniversityOsama Antar, professor, Study director, Suez Canal UniversityMohamed A Elsholkamy, professor, Study director, Suez Canal UniversityMohamed Nageh, Dr, Study director, Suez Canal UniversityAliaa E Ebrahim, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924216
- Sponsor's protocol ID
- 2024/801
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bayerlein T, Proff P, Heinrich A, Kaduk W, Hosten N, Gedrange T. Evaluation of bone availability in the cleft area following secondary osteoplasty. J Craniomaxillofac Surg. 2006 Sep;34 Suppl 2:57-61. doi: 10.1016/S1010-5182(06)60013-9.
PubMed 17071393
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Using Iliac Crest Graft With and Without Platelet-Rich Fibrin (PRF) in Repair of Congenital Alveolar Cleft
- ClinicalTrials.gov ID
- NCT06924216
- Acronym / sponsor ID
- 2024/801
- Conditions
- Alveolar Clefts, Alveolar Bone Grafting, Alveolar Bone Loss
- Keywords
- alveolar clefts, iliac crest, graft, PRF
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Apr 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.
A randomized clinical trial aims to evaluate the clinical and radiographic outcomes of the repair of congenital alveolar clefts using Iliac crest graft with and without mixing with platelet-rich fibrin
Detailed description
Alveolar clefts occur in response to deviations from normal development in the growth, exposure, and fusion of the frontal eminence. The most common alveolar portion of the cleft is located between the central incisors and canines. The treatment of alveolar clefts is multidisciplinary and aimed at restoring normal ridge contour and functionality. Surgical wound closure is insufficient to repair bony defects, Additional materials are needed for these types of defects, such as bone grafts. Aim: The aim of this study is to evaluate the efficiency of using iliac crest bone graft with and without platelet-rich fibrin in repair of alveolar clefts. Methodology: This study will be conducted on 16 patients with alveolar clefts. The patients will be divided equally and randomly into 2 groups: Group 1 : 8 patients will be treated with iliac crest bone graft only (control group).Group 2: 8 patients will be treated with iliac crest bone graft with platelet-rich fibrin (study group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| with platelet-rich fibrin | Experimental | Procedure: alveolar bone grafting Plus Platelet rich fibrinstudy group: the patients will be treated with iliac crest bone graft with platelet-rich fibrin |
| without Platelet-rich fibrin | Active comparator | Procedure: alveolar bone graftingcontrol group : the patients will be treated with iliac crest bone graft only |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with congenital alveolar cleft who need secondary alveolar cleft repair.
- Patients who are medically fit for surgery under general anaesthesia
Key exclusion criteria (2 listed)
- ASA 4 OR ASA 5 patients
- Uncooperative 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 |
|---|---|---|
| alveolar bone graftingAlso: Repair of alveolar cleftscancellous iliac crest bone will be harvested following the usual surgical procedure. For patients of group a-PRF, it was mixed with 1 cc of the supernatant previously collected, in order to obtain a cohesive bone graft, easier to manipulate. The oral mucosal lining will be closed, and a membrane of PRF (PRF group) will be put over the suture line. The alveolar cleft will be then filled with cancellous iliac crest bone along its entire height. A new membrane of PRF will be placed over the bone graft, in order to enclose and protect it. Finally, muco-periosteal flaps will be advanced and sutured without tension over the alveolar crest | Procedure or surgery | without Platelet-rich fibrin |
| alveolar bone grafting Plus Platelet rich fibrinAlso: PRFthe PRF group: centrifugation at 1300 rpm during 5 minutes, collection of 1 cc of the supernatant, and centrifugation at 1300 rpm during 3 minutes. Careful removal of the clot and separation from the red blood cell fraction with scissors. the Platelet-rich fibrin will be added to the surgical site mixed with the iliac crest bone graft and it will also be used as a membrane before closure of the mucoperiosteal flap | Procedure or surgery | with platelet-rich fibrin |
Primary outcome
Changes in bucco-lingual thickness of the bone at the recipient site
Time frame: 3 months and 6 months postoperatively
Post-operative cone beam computed tomographic radiographs will be done using the Scanora 3DX imaging system using a CMOS flat panel detector with isotropic voxel size 133 µm. The x-ray tube that is used to scan the patients possesses a current intensity of 10 mA, 90 KVp, and a focal spot size of 0.5 mm. The scanning time is 14 seconds of pulsed exposure, resulting in an effective exposure time of 3.2 seconds to scan FOV (field of view) of 14 cm height × 16.5 cm width. The raw DICOM data set images will be imported to the On-Demand software (Cybermed, Seoul, Korea) for secondary reconstruction and image analysis. CBCT will be performed, and linear measurements will be obtained in axial, sagittal, and coronal cuts to assess the changes in buccolingual thickness of the bone at the recipient site 3 months and 6 months post-operatively.
2 secondary outcomes
Calculation of the volume of bone fill in the recipient site
Time frame: 6 months postoperative
wound dehiscence
Time frame: immediate, 7 days and 14 days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 17071393Bayerlein T, Proff P, Heinrich A, Kaduk W, Hosten N, Gedrange T. Evaluation of bone availability in the cleft area following secondary osteoplasty. J Craniomaxillofac Surg. 2006 Sep;34 Suppl 2:57-61. doi: 10.1016/S1010-5182(06)60013-9.
- Individual participant dataSharing planned: No
Related trials for Alveolar Clefts
Recruiting
Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
Orofacial Clefts, Cleft Lip and Palate
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.
Mohamed S Hamed, professor study director
Suez Canal University
Osama Antar, professor study director
Suez Canal University
Mohamed A Elsholkamy, professor study director
Suez Canal 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 alveolar bone grafting and alveolar bone grafting Plus Platelet rich fibrin in people with Alveolar Clefts and Alveolar Bone Grafting, run by Suez Canal 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in bucco-lingual thickness of the bone at the recipient site (time frame: 3 months and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924216, which also lists 1 linked publication.
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 11 Apr 2025.