Alveolar Bone LossNCT02741752
The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans
A study testing Decortication in people with Alveolar Bone Loss, run by Mashhad University of Medical Sciences.
Trial summary
The purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR. Read more about this study
- Who is it for?
- Ages 25 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Decortication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 25 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria were presence of atrophic mandibular ridges with bucco-lingual width ranging between 2-5 mm, as measured on serial sections of a computerized axial tomography (CAT) scan.
Who cannot join
- Exclusion criteria included patients with diabetes, osteoporosis or other metabolic disorders, smokers, pregnant patients and patients who had any systemic or local factors that would inhibit normal wound healing process.
About this study
Official title: The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans: A Randomized Clinical Trial
The purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.
Read the detailed description
Background: The purpose of the current study was to evaluate the effect of cortical bone perforation on angiogenesis and osteogenesis of augmented ridge by guided bone regeneration.
Methods: Fourteen patients (mean age: 52) who were in need of dental implants at areas with osseous defects in the mandible were selected. In the test group (n=7), alveolar cortical bone at the area of regeneration was perforated using a #2 high speed round bur. No decortication of cortical bone was performed in the control group (n=7). Subsequently, defects were augmented by guided bone regeneration using resorbable membrane and bovine bone. After a healing period of 7 months, implant sites were created and trephine cores harvested for histological and histomorphometric analysis of the grafted areas.
- Conditions
- Alveolar Bone Loss
- Being tested
- Decortication
- Keywords
- histomorphometry
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecorticationProcedure or surgery
cortical bone perforation
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | decortication group Receives: Procedure: Decortication |
| control | No intervention | without decortication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyedamir Danesh Sani, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741752
- Sponsor's protocol ID
- 97345
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: AA
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02741752
- Acronym / sponsor ID
- 97345
- Conditions
- Alveolar Bone Loss
- Keywords
- histomorphometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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 purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.
Detailed description
Background: The purpose of the current study was to evaluate the effect of cortical bone perforation on angiogenesis and osteogenesis of augmented ridge by guided bone regeneration.
Methods: Fourteen patients (mean age: 52) who were in need of dental implants at areas with osseous defects in the mandible were selected. In the test group (n=7), alveolar cortical bone at the area of regeneration was perforated using a #2 high speed round bur. No decortication of cortical bone was performed in the control group (n=7). Subsequently, defects were augmented by guided bone regeneration using resorbable membrane and bovine bone. After a healing period of 7 months, implant sites were created and trephine cores harvested for histological and histomorphometric analysis of the grafted areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: Decorticationdecortication group |
| control | No intervention | –without decortication |
Who may qualify
- Ages
- 25 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were presence of atrophic mandibular ridges with bucco-lingual width ranging between 2-5 mm, as measured on serial sections of a computerized axial tomography (CAT) scan.
Key exclusion criteria (1 listed)
- Exclusion criteria included patients with diabetes, osteoporosis or other metabolic disorders, smokers, pregnant patients and patients who had any systemic or local factors that would inhibit normal wound healing process.
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 |
|---|---|---|
| Decorticationcortical bone perforation | Procedure or surgery | test group |
Primary outcome
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
Time frame: 7 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 18 Apr 2016.
- Individual participant dataSharing planned: Undecided. AA
Related trials for Alveolar Bone Loss
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
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 Decortication in people with Alveolar Bone Loss, run by Mashhad University of Medical Sciences.
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 1 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: finished, as of the sponsor's last update on 18 Apr 2016. 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?
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?
The amount of vital bone formation by histomorphometric analysis after cortical bone perforation (time frame: 7 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 18 Apr 2016.