Alveolar CleftNCT06523855
Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique
A study testing bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation in people with Alveolar Cleft, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jul 2024to 1 Jul 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
- repaired cleft lip.
- 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 unilateral maxillary alveolar cleft.
- Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
- Subjected to irradiation in the head and neck area less than 1 year before surgery.
- Untreated periodontitis.
- Poor oral hygiene.
Show all 12Show fewer
- Uncontrolled diabetes.
- Immunosuppressed or immunocompromised.
- Active infection or severe inflammation in the area intended for graft placement
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Unable to attend a 9-month follow-up.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo university
Cairo, 12311
Mohamed Omara, PhD, 01144452862 ext. +2, mohammed.omara@dentistry.cu.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique: A Preliminary Clinical Trial
The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.
Read the detailed description
In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula.
In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.
- Conditions
- Alveolar Cleft
- Being tested
- bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation
- Keywords
- alveolar cleft, iliac crest grafting, microplate, bone resorption, oronasal fistula
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral alveolar cleft grafting using iliac crest particulate and microplate fixationProcedure or surgery
bilateral alveolar cleft grafting using particulate iliac crest graft accompanied with fixation of graft and premaxilla using microplate
| Study group | Role | What they receive |
|---|---|---|
| bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation | Experimental | in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect, 8-hole microplates will be used to fix the premaxilla using screws.
The microplates are to be removed 6 to 9 months postoperatively. Receives: Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation |
| bilateral alveolar cleft grafting using iliac crest particulate | Active comparator | in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect. Receives: Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density immediate versus 6 months postoperatively.
bone density changes are measured using CBCT after 6 months via HU
Measured: 6 months
Secondary outcomes (1)
Bone width and height immediate versus 6 months postoperatively
bone height and width changes are measured using CBCT after 6 months in mm
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 posted26 Jul 2024
- Study start24 Jul 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Ahmed Ibrahim Ahmed, Cairo University
- Investigators
- Sameh Mekhemer, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523855
- Sponsor's protocol ID
- 4623358
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smarius B, Loozen C, Manten W, Bekker M, Pistorius L, Breugem C. Accurate diagnosis of prenatal cleft lip/palate by understanding the embryology. World J Methodol. 2017 Sep 26;7(3):93-100. doi: 10.5662/wjm.v7.i3.93. eCollection 2017 Sep 26.
PubMed 29026689Seifeldin SA. Is alveolar cleft reconstruction still controversial? (Review of literature). Saudi Dent J. 2016 Jan;28(1):3-11. doi: 10.1016/j.sdentj.2015.01.006. Epub 2015 Jun 25.
PubMed 26792963Mahardawi B, Boonsiriseth K, Pairuchvej V, Wongsirichat N. Alveolar cleft bone grafting: factors affecting case prognosis. J Korean Assoc Oral Maxillofac Surg. 2020 Dec 31;46(6):409-416. doi: 10.5125/jkaoms.2020.46.6.409.
PubMed 33377466Boyne PJ, Sands NR. Secondary bone grafting of residual alveolar and palatal clefts. J Oral Surg. 1972 Feb;30(2):87-92. No abstract available.
PubMed 4550446Chen S, Liu B, Liu J, Yin N, Wang Y. Comparison of Three-Dimensional Printing and Computer-aided Engineering in Presurgical Volumetric Assessment of Bilateral Alveolar Clefts. J Craniofac Surg. 2020 Mar/Apr;31(2):412-415. doi: 10.1097/SCS.0000000000006011.
PubMed 31764559
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique: A Preliminary Clinical Trial
- ClinicalTrials.gov ID
- NCT06523855
- Acronym / sponsor ID
- 4623358
- Conditions
- Alveolar Cleft
- Keywords
- alveolar cleft, iliac crest grafting, microplate, bone resorption, oronasal fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 26 Jul 2024 (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 the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.
Detailed description
In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula.
In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation | Experimental | Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixationin bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect, 8-hole microplates will be used to fix the premaxilla using screws. The microplates are to be removed 6 to 9 months postoperatively. |
| bilateral alveolar cleft grafting using iliac crest particulate | Active comparator | Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixationin bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
- repaired cleft lip.
- Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
- Both genders males and females will be included.
Key exclusion criteria (12 listed)
- General contraindications to surgical intervention of the area.
- Patients with unilateral maxillary alveolar cleft.
- Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
- Subjected to irradiation in the head and neck area less than 1 year before surgery.
- Untreated periodontitis.
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 |
|---|---|---|
| bilateral alveolar cleft grafting using iliac crest particulate and microplate fixationbilateral alveolar cleft grafting using particulate iliac crest graft accompanied with fixation of graft and premaxilla using microplate | Procedure or surgery | bilateral alveolar cleft grafting using iliac crest particulate, bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation |
Primary outcome
Bone density immediate versus 6 months postoperatively.
Time frame: 6 months
bone density changes are measured using CBCT after 6 months via HU
1 secondary outcome
Bone width and height immediate versus 6 months postoperatively
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 29026689Smarius B, Loozen C, Manten W, Bekker M, Pistorius L, Breugem C. Accurate diagnosis of prenatal cleft lip/palate by understanding the embryology. World J Methodol. 2017 Sep 26;7(3):93-100. doi: 10.5662/wjm.v7.i3.93. eCollection 2017 Sep 26.
- Background: PubMed 26792963Seifeldin SA. Is alveolar cleft reconstruction still controversial? (Review of literature). Saudi Dent J. 2016 Jan;28(1):3-11. doi: 10.1016/j.sdentj.2015.01.006. Epub 2015 Jun 25.
- Background: PubMed 33377466Mahardawi B, Boonsiriseth K, Pairuchvej V, Wongsirichat N. Alveolar cleft bone grafting: factors affecting case prognosis. J Korean Assoc Oral Maxillofac Surg. 2020 Dec 31;46(6):409-416. doi: 10.5125/jkaoms.2020.46.6.409.
- Background: PubMed 4550446Boyne PJ, Sands NR. Secondary bone grafting of residual alveolar and palatal clefts. J Oral Surg. 1972 Feb;30(2):87-92. No abstract available.
- Background: PubMed 31764559Chen S, Liu B, Liu J, Yin N, Wang Y. Comparison of Three-Dimensional Printing and Computer-aided Engineering in Presurgical Volumetric Assessment of Bilateral Alveolar Clefts. J Craniofac Surg. 2020 Mar/Apr;31(2):412-415. doi: 10.1097/SCS.0000000000006011.
- Individual participant dataSharing planned: No
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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.
Sameh Mekhemer, PhD study director
Cairo 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 bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation 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 4 inclusion and 12 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 26 Jul 2024. 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 Maha Ibrahim, bachelor of dentistry (01116003653 ext. +2, maha.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density immediate versus 6 months postoperatively. (time frame: 6 months). 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 NCT06523855, which also lists 5 linked publications.
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 26 Jul 2024.