Alveolar Cleft GraftingNCT07137975
Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction
A study testing autogenous bone plug and regular autogenous bone grafting in people with Alveolar Cleft Grafting, run by Cairo University at 1 site in Egypt.
Trial summary
Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation. Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Alveolar Cleft Grafting
- What is being tested?
- autogenous bone plug and regular autogenous bone grafting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2025to 30 Sep 2026
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
- Inclusion criteria:
- Patients with unilateral alveolar clefts who completed pre-operative expansion.
- Patients with good oral hygiene.
- Patients free from any medical condition that might compromise the healing process.
- Both males and females will be included in trail.
- Age range from 7 years to 12 years.
- Exclusion criteria:
- Unmotivated/uncooperative patients and/or parents.
- Patients who previously underwent unsuccessful treatment trails.
- Patients with insufficient ridge expansion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction: A Randomized Clinical Trail
Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation.
Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure.
To Augment the alveolar defect in three-dimensions, accurate assessment of alveolar cleft is essential, virtual surgical planning can be combined with 3D printing to re-create the defect virtually. Based of virtually created defect a patient specific mold can be designed. Printed mold will be used as a medium for adding particulate autogenous graft mixed with fibrin glue creating a plug with the precise shape of the alveolar cleft, the fibrin glue will assist in forming the plug as well as acting as a scaffold for migrating fibroblasts as well as a hemostatic barrier, stimulates mesenchymal cell, induces and promotes angiogenesis, and also initiates early osteogenesis.
Read the detailed description
-The aim of this study is to describe an auxiliary surgical techniques in alveolar cleft reconstruction and evaluate volume of the bone.
Research question:
Does the use of patient specific autogenous plug yield better 3D volume than conventional autogenous graft.
Statement of the problem:
Cleft patients need a precise treatment regimen, which makes the treatment challenging. Multidisciplinary approach is required and collaboration of multiple specialties is needed; OMFS, orthodontists, plastic surgeons, speech therapist and pedodontists. One of the most crucial steps in treatment of cleft patients is the repair of the alveolar defect to achieve stability of the arch, provide room for canine and lateral incisor to erupt, maintain periodontal health of adjacent teeth, restore continuity of piriform rim, support the ala of the nose to allow for better facial appearance, closure of oronasal fistula to decrease chance URT infections and allow for better hygiene and speech., It is essential to understand and evaluate the geometry and size of the defect, to avoid improper grafting of the defect, enhance the evaluation of the alveolar defect preoperatively, and the graft integration postoperatively and to allow precise repair of the alveolar defect. (Watted et al., 2020) (Stolarz et al.,2022) Each alveolar cleft has a unique shape in mesio-distally, antro-posteriorly, which creates a challenge to fill the defect in all dimensions. The precise assessment of the cleft geometry can be determined by computed tomography (CT), or cone- beam CT (CBCT) which allows simultaneous alveolar cleft assessment, planning and volume measurement.
4
Rationale for conducting the research:
Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation.
Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure.
To Augment the alveolar defect in three-dimensions, accurate assessment of alveolar cleft is essential, virtual surgical planning can be combined with 3D printing to re-create the defect virtually. Based of virtually created defect a patient specific mold can be designed. Printed mold will be used as a medium for adding particulate autogenous graft mixed with fibrin glue creating a plug with the precise shape of the alveolar cleft, the fibrin glue will assist in forming the plug as well as acting as a scaffold for migrating fibroblasts as well as a hemostatic barrier, stimulates mesenchymal cell, induces and promotes angiogenesis, and also initiates early osteogenesis. (Kesztyűs et al., 2022)
- Conditions
- Alveolar Cleft Grafting
- Being tested
- autogenous bone plug, regular autogenous bone grafting
- Keywords
- Alveolar Cleft, Cleft, Grafting, Ridge Augmentation, 3D defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous bone plugOther
Preoperative assessment of the alveolar defect began with intraoral examination to check a proper transverse relationship between the maxillary segments and the presence of a normal upper arch form.
After the decision on alveolar bone grafting, Radiologic data from the cleft area will be required. Standard protocol is to take a high resolution CT scan of the patient's skull or at least the whole maxilla. Using the DICOM data acquired from the cleft area the bony defect will be segmented with specific software, in our daily routine blender for dental is used. The same program could be used to design the rough shape of the nasoalveolar graft, and this image could be exported in STL (standard tessellation language) format. and once the desired form is aquired, the final step is to construct a mold. For this purpose, the open-source software Blender (Blender Foundation, Amsterdam, and The Netherlands) will be used. After preoperative planning, the designed mold will be printed using polyam
regular autogenous bone graftingOther
Gold standard grafting of alveolar cleft
| Study group | Role | What they receive |
|---|---|---|
| autogenous bone plug | Active comparator | Not described Receives: Other: autogenous bone plug |
| control | Experimental | Not described Receives: Other: regular autogenous bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage fill
Measured: 6 months
Secondary outcomes (1)
bone density
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 posted22 Aug 2025
- Study start30 Aug 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Cleft GraftingStudies 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
- Model description
- Preoperative assessment of the alveolar defect began with intraoral examination to check a proper transverse relationship between the maxillary segments and the presence of a normal upper arch form. After the decision on alveolar bone grafting, Radiologic data from the cleft area will be required. Standard protocol is to take a high resolution CT scan of the patient's skull or at least the whole maxilla. Using the DICOM data acquired from the cleft area the bony defect will be segmented with specific software, in our daily routine blender for dental is used. The same program could be used to design the rough shape of the nasoalveolar graft, and this image could be exported in STL (standard tessellation language) format. and once the desired form is aquired, the final step is to construct a mold. For this purpose, the open-source software Blender (Blender Foundation, Amsterdam, and The Netherlands) will be used. After preoperative planning, the designed mold will be printed using polyam
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Raed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137975
- Sponsor's protocol ID
- OMFS3-3-14
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction: A Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT07137975
- Acronym / sponsor ID
- OMFS3-3-14
- Conditions
- Alveolar Cleft Grafting
- Keywords
- Alveolar Cleft, Cleft, Grafting, Ridge Augmentation, 3D defect
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Aug 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.
Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation.
Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure.
To Augment the alveolar defect in three-dimensions, accurate assessment of alveolar cleft is essential, virtual surgical planning can be combined with 3D printing to re-create the defect virtually. Based of virtually created defect a patient specific mold can be designed. Printed mold will be used as a medium for adding particulate autogenous graft mixed with fibrin glue creating a plug with the precise shape of the alveolar cleft, the fibrin glue will assist in forming the plug as well as acting as a scaffold for migrating fibroblasts as well as a hemostatic barrier, stimulates mesenchymal cell, induces and promotes angiogenesis, and also initiates early osteogenesis.
Detailed description
-The aim of this study is to describe an auxiliary surgical techniques in alveolar cleft reconstruction and evaluate volume of the bone.
Research question:
Does the use of patient specific autogenous plug yield better 3D volume than conventional autogenous graft.
Statement of the problem:
Cleft patients need a precise treatment regimen, which makes the treatment challenging. Multidisciplinary approach is required and collaboration of multiple specialties is needed; OMFS, orthodontists, plastic surgeons, speech therapist and pedodontists. One of the most crucial steps in treatment of cleft patients is the repair of the alveolar defect to achieve stability of the arch, provide room for canine and lateral incisor to erupt, maintain periodontal health of adjacent teeth, restore continuity of piriform rim, support the ala of the nose to allow for better facial appearance, closure of oronasal fistula to decrease chance URT infections and allow for better hygiene and speech., It is essential to understand and evaluate the geometry and size of the defect, to avoid improper grafting of the defect, enhance the evaluation of the alveolar defect preoperatively, and the graft integration postoperatively and to allow precise repair of the alveolar defect. (Watted et al., 2020) (Stolarz et al.,2022) Each alveolar cleft has a unique shape in mesio-distally, antro-posteriorly, which creates a challenge to fill the defect in all dimensions. The precise assessment of the cleft geometry can be determined by computed tomography (CT), or cone- beam CT (CBCT) which allows simultaneous alveolar cleft assessment, planning and volume measurement.
4
Rationale for conducting the research:
Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation.
Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure.
To Augment the alveolar defect in three-dimensions, accurate assessment of alveolar cleft is essential, virtual surgical planning can be combined with 3D printing to re-create the defect virtually. Based of virtually created defect a patient specific mold can be designed. Printed mold will be used as a medium for adding particulate autogenous graft mixed with fibrin glue creating a plug with the precise shape of the alveolar cleft, the fibrin glue will assist in forming the plug as well as acting as a scaffold for migrating fibroblasts as well as a hemostatic barrier, stimulates mesenchymal cell, induces and promotes angiogenesis, and also initiates early osteogenesis. (Kesztyűs et al., 2022)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Preoperative assessment of the alveolar defect began with intraoral examination to check a proper transverse relationship between the maxillary segments and the presence of a normal upper arch form. After the decision on alveolar bone grafting, Radiologic data from the cleft area will be required. Standard protocol is to take a high resolution CT scan of the patient's skull or at least the whole maxilla. Using the DICOM data acquired from the cleft area the bony defect will be segmented with specific software, in our daily routine blender for dental is used. The same program could be used to design the rough shape of the nasoalveolar graft, and this image could be exported in STL (standard tessellation language) format. and once the desired form is aquired, the final step is to construct a mold. For this purpose, the open-source software Blender (Blender Foundation, Amsterdam, and The Netherlands) will be used. After preoperative planning, the designed mold will be printed using polyam
| Arm | Type | Receives |
|---|---|---|
| autogenous bone plug | Active comparator | Other: autogenous bone plug |
| control | Experimental | Other: regular autogenous bone grafting |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 bone plugPreoperative assessment of the alveolar defect began with intraoral examination to check a proper transverse relationship between the maxillary segments and the presence of a normal upper arch form. After the decision on alveolar bone grafting, Radiologic data from the cleft area will be required. Standard protocol is to take a high resolution CT scan of the patient's skull or at least the whole maxilla. Using the DICOM data acquired from the cleft area the bony defect will be segmented with specific software, in our daily routine blender for dental is used. The same program could be used to design the rough shape of the nasoalveolar graft, and this image could be exported in STL (standard tessellation language) format. and once the desired form is aquired, the final step is to construct a mold. For this purpose, the open-source software Blender (Blender Foundation, Amsterdam, and The Netherlands) will be used. After preoperative planning, the designed mold will be printed using polyam | Other | autogenous bone plug |
| regular autogenous bone graftingGold standard grafting of alveolar cleft | Other | control |
Primary outcome
Percentage fill
Time frame: 6 months
1 secondary outcome
bone density
Time frame: 6 months
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 3 Feb 2026.
Related trials for Alveolar Cleft Grafting
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Not yet recruiting
Bone Augmentation Techniques in the Mandible Posterior Region
Bone Substitutes, Alveolar Bone Grafting
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Not yet recruiting
Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique
Alveolar Cleft Grafting
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 bone plug and regular autogenous bone grafting in people with Alveolar Cleft Grafting, run by Cairo 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?
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 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?
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?
Percentage fill (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 3 Feb 2026.