Horizontal Ridge DeficiencyNCT03183336
Horizontal Ridge Augmentation of the Mandible Autogenous Block Grafts
A study testing ridge split interpositional block graft and decortication Onlay block graft in people with Horizontal Ridge Deficiency and Block Graft, run by Cairo University.
Trial summary
20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency, Block Graft
- What is being tested?
- ridge split interpositional block graft and decortication Onlay block graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Sep 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of both sexes with a minimum vertical bone height above the inferior alveolar canal of 10mm in the edentulous region.
- Patients should have ridge thickness less than 5mm measured 2mm from the alveolar crest Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
Who cannot join
- Patients with any systemic disease that may affect normal bone healing. Patients with drug allergies, drug or alcohol abuse, periodontal diseases or poor oral hygiene
About this study
Official title: Horizontal Ridge Augmentation of the Mandible Using Interpositional Autogenous Block Grafts Versus Onlay Block Grafts; Randomized Controlled Clinical Trial
20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. the second group received onlay block grafts (harvested from the chin and ramus) and covered with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge width dimensions is then measured using radiographic analysis using cone-beam computed tomography scans
- Conditions
- Horizontal Ridge Deficiency, Block Graft
- Being tested
- ridge split interpositional block graft, decortication Onlay block graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridge split interpositional block graftProcedure or surgery
decortication Onlay block graftProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Interpositional block graft | Experimental | ridge split interpositional block graft Receives: Procedure: ridge split interpositional block graft |
| Onlay block graft | Active comparator | decortication onlay block graft Receives: Procedure: decortication Onlay block graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar ridge width gained
radiographic analysis following ridge augmentation using Cone beam computed tomography
Measured: 4 months
Secondary outcomes (1)
patient morbidity following the surgical procedure
pain value on pain scale
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startJul 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Ridge DeficiencyStudies 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed H Osman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183336
- Sponsor's protocol ID
- cebc.cairou
- Status last verified
- Jul 2017
- First submitted
- 6 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Ridge Augmentation of the Mandible Using Interpositional Autogenous Block Grafts Versus Onlay Block Grafts; Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03183336
- Acronym / sponsor ID
- cebc.cairou
- Conditions
- Horizontal Ridge Deficiency, Block Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 12 Jun 2017 (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.
20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. the second group received onlay block grafts (harvested from the chin and ramus) and covered with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge width dimensions is then measured using radiographic analysis using cone-beam computed tomography scans
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpositional block graft | Experimental | Procedure: ridge split interpositional block graftridge split interpositional block graft |
| Onlay block graft | Active comparator | Procedure: decortication Onlay block graftdecortication onlay block graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of both sexes with a minimum vertical bone height above the inferior alveolar canal of 10mm in the edentulous region.
- Patients should have ridge thickness less than 5mm measured 2mm from the alveolar crest Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
Key exclusion criteria (1 listed)
- Patients with any systemic disease that may affect normal bone healing. Patients with drug allergies, drug or alcohol abuse, periodontal diseases or poor oral hygiene
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 |
|---|---|---|
| ridge split interpositional block graft | Procedure or surgery | Interpositional block graft |
| decortication Onlay block graft | Procedure or surgery | Onlay block graft |
Primary outcome
alveolar ridge width gained
Time frame: 4 months
radiographic analysis following ridge augmentation using Cone beam computed tomography
1 secondary outcome
patient morbidity following the surgical procedure
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: Yes
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ridge split interpositional block graft and decortication Onlay block graft in people with Horizontal Ridge Deficiency and Block Graft, run by Cairo University.
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 1 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
alveolar ridge width gained (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 11 Jul 2017.