Alveolar CleftNCT05283005
Alveolar Cleft Grafting by Double Iliac Bone Blocks Versus Iliac Spongy Bone From Anterior Iliac Crest
A study testing Grafting of the alveolar cleft in people with Alveolar Cleft, run by Cairo University at 1 site in Egypt.
Trial summary
Reconstruction of Alveolar Cleft Using Double Iliac Corticocancellous Blocks in comparison with the gold standard technique ( cancellous bone ) both from anterior iliac crest. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- Grafting of the alveolar cleft
- 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
- 28 Dec 2021to 31 Dec 2022
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with complete maxillary alveolar cleft either unilateral or bilateral at the age of mixed dentition (between 7 and 13 years old).
- repaired cleft lip.
- Patients with cleft lip and palate who have not undergone alveolar grafting procedure.
- Patients with unerupted maxillary permanent canine in the cleft region.
- Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
- Both genders males and females will be included
Who cannot join
- General contraindications to surgical intervention of the area. Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft.
- Patients with associated syndrome.
- Patients requiring concomitant Orthognathic surgical procedure.
- Subjected to irradiation in the head and neck area less than 1 year before surgery.
- Untreated periodontitis.
- Poor oral hygiene.
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- Uncontrolled diabetes.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Active infection or severe inflammation in the area intended for graft placement.
- Patients participating in other studies, if the present protocol could not be properly followed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Cairo university
Cairo
Mohammed A Omara, PhD, 00201144452862
About this study
Official title: Alveolar Cleft Reconstruction Using Double Iliac Corticocancellous Bone Blocks Technique Versus Particulate Autogenous Spongy Bone Graft From Anterior Iliac Crest. A Randomized Clinical Trial
Reconstruction of Alveolar Cleft Using Double Iliac Corticocancellous Blocks in comparison with the gold standard technique ( cancellous bone ) both from anterior iliac crest.
Read the detailed description
This study will compare two techniques for the proper alveolar cleft reconstruction with adequate bone bridge formation of maximum bone quality, contour, and minimal resorption. One of them is packing autogenous particulate spongy bone from the anterior iliac crest (gold standard). While the other technique would be reconstruction of the cleft with two iliac corticocancellous bone blocks with cancellous bone in between. which benefits of the rapid revascularization and healing of cancellous bone and the strong mechanical properties of cortical bone that will aid in obtaining a proper reconstruction and form for the defect and can be applied to defects of any size.
- Conditions
- Alveolar Cleft
- Being tested
- Grafting of the alveolar cleft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grafting of the alveolar cleftProcedure or surgery
alveolar cleft grafting using either the conventional technique or the double cortex technique
| Study group | Role | What they receive |
|---|---|---|
| alveolar cleft patients will be treated by conventional technique | Active comparator | Reconstruction of alveolar cleft by autogenous cancellous bone from the anterior iliac crest (gold standard technique). Receives: Procedure: Grafting of the alveolar cleft |
| alveolar cleft patients will be treated by double cortex technique | Experimental | Reconstruction of alveolar cleft by autogenous double iliac cortico-cancellous bone blocks from the anterior iliac crest. Receives: Procedure: Grafting of the alveolar cleft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring graft height in millimeters
CBCT scan analysis for measuring mean graft height in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft height in millimeters after 9 months of every graft for assessment of grafts height stability of both groups over 9 months.
Measured: 9 months
Measuring graft width in millimeters
CBCT scan analysis for measuring mean graft width in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft width in millimeters after 9 months of every graft for assessment of grafts width stability of both groups over 9 months.
Measured: 9 months
Secondary outcomes (1)
Measuring graft volume in cubic millimeter
CBCT scan analysis for measuring graft volume in cubic millimeter of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring graft volume in cubic millimeter after 9 months of every graft for assessment of grafts volume stability of both groups over 9 months.
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 posted16 Mar 2022
- Study start28 Dec 2021
- Primary completion29 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louai Ahmed Rafat Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283005
- Sponsor's protocol ID
- 29-12-21
- Status last verified
- Mar 2022
- First submitted
- 16 Feb 2022
- Last updated
- 16 Mar 2022
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Cleft Reconstruction Using Double Iliac Corticocancellous Bone Blocks Technique Versus Particulate Autogenous Spongy Bone Graft From Anterior Iliac Crest. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05283005
- Acronym / sponsor ID
- 29-12-21
- Conditions
- Alveolar Cleft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 29 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Mar 2022 (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.
Reconstruction of Alveolar Cleft Using Double Iliac Corticocancellous Blocks in comparison with the gold standard technique ( cancellous bone ) both from anterior iliac crest.
Detailed description
This study will compare two techniques for the proper alveolar cleft reconstruction with adequate bone bridge formation of maximum bone quality, contour, and minimal resorption. One of them is packing autogenous particulate spongy bone from the anterior iliac crest (gold standard). While the other technique would be reconstruction of the cleft with two iliac corticocancellous bone blocks with cancellous bone in between. which benefits of the rapid revascularization and healing of cancellous bone and the strong mechanical properties of cortical bone that will aid in obtaining a proper reconstruction and form for the defect and can be applied to defects of any size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alveolar cleft patients will be treated by conventional technique | Active comparator | Procedure: Grafting of the alveolar cleftReconstruction of alveolar cleft by autogenous cancellous bone from the anterior iliac crest (gold standard technique). |
| alveolar cleft patients will be treated by double cortex technique | Experimental | Procedure: Grafting of the alveolar cleftReconstruction of alveolar cleft by autogenous double iliac cortico-cancellous bone blocks from the anterior iliac crest. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients with complete maxillary alveolar cleft either unilateral or bilateral at the age of mixed dentition (between 7 and 13 years old).
Key exclusion criteria (11 listed)
- General contraindications to surgical intervention of the area. Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft.
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 |
|---|---|---|
| Grafting of the alveolar cleftalveolar cleft grafting using either the conventional technique or the double cortex technique | Procedure or surgery | alveolar cleft patients will be treated by conventional technique, alveolar cleft patients will be treated by double cortex technique |
Primary outcome
Measuring graft height in millimeters
Time frame: 9 months
CBCT scan analysis for measuring mean graft height in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft height in millimeters after 9 months of every graft for assessment of grafts height stability of both groups over 9 months.
Measuring graft width in millimeters
Time frame: 9 months
CBCT scan analysis for measuring mean graft width in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft width in millimeters after 9 months of every graft for assessment of grafts width stability of both groups over 9 months.
1 secondary outcome
Measuring graft volume in cubic millimeter
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grafting of the alveolar cleft in people with Alveolar Cleft, 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?
The sponsor lists 6 inclusion and 11 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 16 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louai A Raafat, BDS (00201142904383, louai.raafat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring graft height in millimeters (time frame: 9 months). 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 16 Mar 2022.