Horizontal Atrophy of Edentulous Alveolar RidgeNCT04567966
Cortical Bone Plate Versus Cortico-cancellous Block Graft
A study testing Split-block technique and Cortico-cancellous block graft in people with Horizontal Atrophy of Edentulous Alveolar Ridge, run by Ain Shams University at 1 site in Egypt.
Trial summary
Horizontal ridge augmentation using either cortical bone plate technique or cortico-cancellous block graft was the aim of the study. Bone quality was analyzed histomorphomterically, and horizontal dimensional changes were assessed using CBCT. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Atrophy of Edentulous Alveolar Ridge
- What is being tested?
- Split-block technique and Cortico-cancellous 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
- 1 siteEgypt
- Study dates
- 28 Aug 2018to 3 Mar 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible patients aged 18 years or older with partial edentulism of the mandible
- The residual ridge width must be 4 mm or less
- Intra-oral donor sites should be available in the external oblique ridge and symphyseal area
Who cannot join
- Patients with general contraindications for implant surgery such as uncontrolled diabetes
- Irradiation of the head and neck region
- Intravenous bisphosphonate
- Pregnancy
- Smokers, alcoholics and drug abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cortical Bone Plate Versus Cortico-cancellous Block Graft for Horizontal Ridge Augmentation: Histomorphometric and Cone Beam Computed Tomography Study
Horizontal ridge augmentation using either cortical bone plate technique or cortico-cancellous block graft was the aim of the study. Bone quality was analyzed histomorphomterically, and horizontal dimensional changes were assessed using CBCT.
- Being tested
- Split-block technique, Cortico-cancellous block graft
- Keywords
- Split-bone block technique, Cortical bone plate, Cortico-cancellous block graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-block techniqueProcedure or surgery
Horizontal ridge augmentation using the split-block technique where a cortical bone plate harvested from the external oblique ridge was split in half and fixed at a distance from the atrophied ridge. Then autogenous bone chips were packed in the gap between the plate and the ridge.
Cortico-cancellous block graftProcedure or surgery
Horizontal ridge augmentation using a cortico-cancellous block harvested from the chin of the mandible.
| Study group | Role | What they receive |
|---|---|---|
| Cortical bone plate | Experimental | A cortical plate was harvested from the external oblique ridge and split in half. Then one plate was fixed at a distance from the atrophied ridge and autogenous bone chips were used to fill the gap between the plate and the ridge. Receives: Procedure: Split-block technique |
| Cortico-cancellous block graft | Active comparator | A cortico-cancellous block graft was harvested from the symphysis of the mandible and fixed to the atrophied ridge. Receives: Procedure: Cortico-cancellous block graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of bone quality
Histomorphometric analysis (Masson's Trichrome stain)
Measured: 4 months
Secondary outcomes (1)
Horizontal ridge dimensional changes
Measuring the linear horizontal changes using CBCT
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start28 Aug 2018
- Primary completion6 Jan 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Atrophy of Edentulous Alveolar RidgeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adel Rizk Botros, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567966
- Sponsor's protocol ID
- PER 18-1D
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Bone Plate Versus Cortico-cancellous Block Graft for Horizontal Ridge Augmentation: Histomorphometric and Cone Beam Computed Tomography Study
- ClinicalTrials.gov ID
- NCT04567966
- Acronym / sponsor ID
- PER 18-1D
- Keywords
- Split-bone block technique, Cortical bone plate, Cortico-cancellous block graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 29 Sep 2020 (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.
Horizontal ridge augmentation using either cortical bone plate technique or cortico-cancellous block graft was the aim of the study. Bone quality was analyzed histomorphomterically, and horizontal dimensional changes were assessed using CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortical bone plate | Experimental | Procedure: Split-block techniqueA cortical plate was harvested from the external oblique ridge and split in half. Then one plate was fixed at a distance from the atrophied ridge and autogenous bone chips were used to fill the gap between the plate and the ridge. |
| Cortico-cancellous block graft | Active comparator | Procedure: Cortico-cancellous block graftA cortico-cancellous block graft was harvested from the symphysis of the mandible and fixed to the atrophied ridge. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eligible patients aged 18 years or older with partial edentulism of the mandible
- The residual ridge width must be 4 mm or less
- Intra-oral donor sites should be available in the external oblique ridge and symphyseal area
Key exclusion criteria (5 listed)
- Patients with general contraindications for implant surgery such as uncontrolled diabetes
- Irradiation of the head and neck region
- Intravenous bisphosphonate
- Pregnancy
- Smokers, alcoholics and drug abusers
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 |
|---|---|---|
| Split-block techniqueHorizontal ridge augmentation using the split-block technique where a cortical bone plate harvested from the external oblique ridge was split in half and fixed at a distance from the atrophied ridge. Then autogenous bone chips were packed in the gap between the plate and the ridge. | Procedure or surgery | Cortical bone plate |
| Cortico-cancellous block graftHorizontal ridge augmentation using a cortico-cancellous block harvested from the chin of the mandible. | Procedure or surgery | Cortico-cancellous block graft |
Primary outcome
Evaluation of bone quality
Time frame: 4 months
Histomorphometric analysis (Masson's Trichrome stain)
1 secondary outcome
Horizontal ridge dimensional changes
Time frame: 4 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 29 Sep 2020.
- Individual participant dataSharing planned: Yes
Related trials for Horizontal Atrophy of Edentulous Alveolar Ridge
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
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 Split-block technique and Cortico-cancellous block graft in people with Horizontal Atrophy of Edentulous Alveolar Ridge, run by Ain Shams 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 3 inclusion and 5 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 29 Sep 2020. 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?
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?
Evaluation of bone quality (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 29 Sep 2020.