Alveolar Ridge AugmentationNCT01361321
Bone Quality and Quantity Following Guided Bone Regeneration
An observational study of Alveolar Ridge Augmentation, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance. Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2012to 21 Feb 2013
- Phase
- Observational
- 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
Study population: Healty over 18 years of age Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been insertd yet
Who may be able to join
- Healthy men and women over 18 years of age, eligible for signing
- Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been inserted yet
- Patients who understand the meaning of the treatment (routine dental implant insertion) and the follow up study, and approves participation in booth of them
Who cannot join
- Pregnant or nursing women. children or non judgemental patients
- Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
- Patients with a pathology present near the site of dental implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Bone Quantity and Quality Following Standard Guided Bone Regeneration Procedures
Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance.
Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area.
The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- follow up, Guided bone regeneration, Micro computerized tomography, histological examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients after GBR procedure | The study will comprise of patients who already underwent a routine Guided Bone Regeneration (GBR) procedure in order to augment a bony ridge before dental implant insertion. The patients will be followed up in order to determine bone quality and quantity formed after the usage of routinely used bone substitutes during GBR procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of the new bone formed after a GBR procedure
Bone volume obtained following a GBR procedure will be detemined through a comparison of a 3 dimensional analysis of computed tomography images done before and after the GBR procedure.
Measured: Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.
Secondary outcomes (1)
Bone quality
The collected bone sample will be subjected to histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae,the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio.
Measured: Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startFeb 2012
- Primary completion21 Feb 2013
- Study completion21 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lior Shapira, Professor, Principal investigator, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361321
- Sponsor's protocol ID
- bondbone-HMO-CTIL
- Status last verified
- Sep 2013
- First submitted
- 18 May 2011
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Bone Quantity and Quality Following Standard Guided Bone Regeneration Procedures
- ClinicalTrials.gov ID
- NCT01361321
- Acronym / sponsor ID
- bondbone-HMO-CTIL
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- follow up, Guided bone regeneration, Micro computerized tomography, histological examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 21 Feb 2013 (actual)
- Study completion
- 21 Feb 2013 (actual)
- First posted
- 26 May 2011 (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.
Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance.
Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area.
The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients after GBR procedure | – | –The study will comprise of patients who already underwent a routine Guided Bone Regeneration (GBR) procedure in order to augment a bony ridge before dental implant insertion. The patients will be followed up in order to determine bone quality and quantity formed after the usage of routinely used bone substitutes during GBR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healty over 18 years of age Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been insertd yet
Key inclusion criteria (3 listed)
- Healthy men and women over 18 years of age, eligible for signing
- Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been inserted yet
- Patients who understand the meaning of the treatment (routine dental implant insertion) and the follow up study, and approves participation in booth of them
Key exclusion criteria (3 listed)
- Pregnant or nursing women. children or non judgemental patients
- Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
- Patients with a pathology present near the site of dental implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume of the new bone formed after a GBR procedure
Time frame: Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.
Bone volume obtained following a GBR procedure will be detemined through a comparison of a 3 dimensional analysis of computed tomography images done before and after the GBR procedure.
1 secondary outcome
Bone quality
Time frame: Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure.
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 30 Nov 2017.
Related trials for Alveolar 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.
Lior Shapira, Professor principal investigator
Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Ridge Augmentation, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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 30 Nov 2017. 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 Israel. 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?
Volume of the new bone formed after a GBR procedure (time frame: Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.). 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 30 Nov 2017.