Alveolar CleftAlveolar cleftNCT06304376
Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting
A study testing Alveolar ridge grafting in people with Alveolar Cleft and Alveolar Ridge Cleft, run by October 6 University at 1 site in Kuwait.
Trial summary
This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Alveolar Cleft, Alveolar Ridge Cleft
- What is being tested?
- Alveolar ridge grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteKuwait
- Study dates
- 12 Mar 2022to 22 Feb 2024
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with alveolar ridge cleft
- Males and females 7-14 years of age.
- Patients with adequate oral hygiene.
- Compliance with all requirements in the study and signing the informed consent.
Who cannot join
- Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
- Patients with systemic disease affecting bone healing.
- Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
- Patients with history of intravenous and/or oral bisphosphonate use.
- Pathologic lesions or acute infection in the area of defect.
- Patients with poor oral hygiene that are not amenable to motivation and improvement.
- 8. Vulnerable patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Shell Technique for Reconstruction of Alveolar Cleft: Retrospective Study
This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.
- Conditions
- Alveolar Cleft, Alveolar Ridge Cleft
- Being tested
- Alveolar ridge grafting
- Keywords
- alveolar ridge cleft, Khoury shell technique, 3D alveolar ridge reconstruction, anterior iliac crest bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge graftingProcedure or surgery
Alveolar ridge grafting was carried out using anterior iliac crest bone graft. Khoury shell technique was the method of ridge reconstruction via a cortical bone shell was fixed away from alveolar ridge using two micro-screws and the gap created was filled by cancellous bone
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | This study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting Receives: Procedure: Alveolar ridge grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric bone gain
bone volumetric gain and changes measured by CBCT analysis
Measured: 4 months
Secondary outcomes (1)
Eruption of the tooth in the cleft
Eruption of the tooth assessed clinically and radiographically
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start12 Mar 2022
- Primary completion30 Nov 2023
- Study completion22 Feb 2024
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.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Responsible party
- Principal investigator, Khalid Tarek Mohamed Karkar, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304376
- Sponsor's protocol ID
- OMFS/FSDC002
- Acronym
- Alveolar cleft
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Shell Technique for Reconstruction of Alveolar Cleft: Retrospective Study
- ClinicalTrials.gov ID
- NCT06304376
- Acronym / sponsor ID
- Alveolar cleft / OMFS/FSDC002
- Conditions
- Alveolar Cleft, Alveolar Ridge Cleft
- Keywords
- alveolar ridge cleft, Khoury shell technique, 3D alveolar ridge reconstruction, anterior iliac crest bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Kuwait
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 12 Mar 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.
This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Procedure: Alveolar ridge graftingThis study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with alveolar ridge cleft
- Males and females 7-14 years of age.
- Patients with adequate oral hygiene.
- Compliance with all requirements in the study and signing the informed consent.
Key exclusion criteria (7 listed)
- Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
- Patients with systemic disease affecting bone healing.
- Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
- Patients with history of intravenous and/or oral bisphosphonate use.
- Pathologic lesions or acute infection in the area of defect.
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 ridge graftingAlveolar ridge grafting was carried out using anterior iliac crest bone graft. Khoury shell technique was the method of ridge reconstruction via a cortical bone shell was fixed away from alveolar ridge using two micro-screws and the gap created was filled by cancellous bone | Procedure or surgery | study group |
Primary outcome
Volumetric bone gain
Time frame: 4 months
bone volumetric gain and changes measured by CBCT analysis
1 secondary outcome
Eruption of the tooth in the cleft
Time frame: 6-9 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 12 Mar 2024.
- 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.
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 Alveolar ridge grafting in people with Alveolar Cleft and Alveolar Ridge Cleft, run by October 6 University at 1 site in Kuwait.
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 7 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 12 Mar 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 Kuwait. 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?
Volumetric bone gain (time frame: 4 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 12 Mar 2024.