Alveolar Bone LossPhase 1NCT01105026
A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™
A Phase 1 study testing Alveolar Bone Defect Regeneration Following Tooth Extraction in people with Alveolar Bone Loss, run by University of Trieste.
Trial summary
The aim of this study was to evaluate by histology and MSCT scans during a 7-month period, the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in the maintenance of alveolar ridge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Alveolar Bone Defect Regeneration Following Tooth Extraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Nov 2009
- Phase
- Phase 1
- 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
- Systemically healthy females or males subjects.
- They did not smoke
- Did not take any medications.
Who cannot join
- Subjects with less than 18 years of age,
- with current alcohol or drug abuse,
- with systemic/local conditions that would interfere with wound healing or osseointegration
- with a history of chemotherapy and radiotherapy in the head and neck region.
About this study
Official title: Bone Regeneration by Means of a Bioactive Glass Scaffold.
The aim of this study was to evaluate by histology and MSCT scans during a 7-month period, the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in the maintenance of alveolar ridge.
Read the detailed description
14 subjects in need of implant therapy were enrolled in the study. A total of 32 teeth were extracted and the fresh sockets underwent to ridge preservation procedures using Inion BioRestore™. Two different time points (1 week and 3 months after RPP) MSCT scans for each patient were used as a basis for bone change analysis occurred in the localized grafted alveolar sites. Twenty-two biopsied, representative of intermediate (3-4 months, n=10) and late phase (6-7 months, n=12) of healing, were harvested and histologically analysed.
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar Bone Defect Regeneration Following Tooth Extraction
- Keywords
- alveolar ridge preservation, bioactive glass, tooth extraction, graft material
- 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.
Alveolar Bone Defect Regeneration Following Tooth ExtractionDevice
Patients underwent surgery under local anesthesia and minimally invasive periotomy was carried out with a surgical blade. Atraumatic extraction with forceps was performed. The extraction socket was carefully curetted to remove the granulation tissue and was rinsed with a physiologic solution. To evaluate the eligibility of the surgical site, the alveolar walls integrity was checked clinically and by means of extemporaneous peri-apical radiography.
Then, the socket was filled to the bone margin with Inion BioRestore™ (granules size 1 to 2 millimetres). Finally, single interrupted (5-0) sutures were tightened to promote the stability of grafted particles. Ten days after the surgery, sutures were removed.
| Study group | Role | What they receive |
|---|---|---|
| bioactive glass | Experimental | Not described Receives: Device: Alveolar Bone Defect Regeneration Following Tooth Extraction |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Collaborators
- Inion Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105026
- Sponsor's protocol ID
- CBT-109-CT
- Status last verified
- Nov 2009
- First submitted
- 15 Apr 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clozza E, Biasotto M, Cavalli F, Moimas L, Di Lenarda R. Three-dimensional evaluation of bone changes following ridge preservation procedures. Int J Oral Maxillofac Implants. 2012 Jul-Aug;27(4):770-5.
PubMed 22848877Clozza E, Pea M, Cavalli F, Moimas L, Di Lenarda R, Biasotto M. Healing of fresh extraction sockets filled with bioactive glass particles: histological findings in humans. Clin Implant Dent Relat Res. 2014 Feb;16(1):145-53. doi: 10.1111/j.1708-8208.2012.00463.x. Epub 2012 Jun 12.
PubMed 22691124
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Regeneration by Means of a Bioactive Glass Scaffold.
- ClinicalTrials.gov ID
- NCT01105026
- Acronym / sponsor ID
- CBT-109-CT
- Conditions
- Alveolar Bone Loss
- Keywords
- alveolar ridge preservation, bioactive glass, tooth extraction, graft material
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Collaborators
- Inion Oy
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Apr 2010 (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 aim of this study was to evaluate by histology and MSCT scans during a 7-month period, the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in the maintenance of alveolar ridge.
Detailed description
14 subjects in need of implant therapy were enrolled in the study. A total of 32 teeth were extracted and the fresh sockets underwent to ridge preservation procedures using Inion BioRestore™. Two different time points (1 week and 3 months after RPP) MSCT scans for each patient were used as a basis for bone change analysis occurred in the localized grafted alveolar sites. Twenty-two biopsied, representative of intermediate (3-4 months, n=10) and late phase (6-7 months, n=12) of healing, were harvested and histologically analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bioactive glass | Experimental | Device: Alveolar Bone Defect Regeneration Following Tooth Extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systemically healthy females or males subjects.
- They did not smoke
- Did not take any medications.
Key exclusion criteria (4 listed)
- Subjects with less than 18 years of age,
- with current alcohol or drug abuse,
- with systemic/local conditions that would interfere with wound healing or osseointegration
- with a history of chemotherapy and radiotherapy in the head and neck region.
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 Bone Defect Regeneration Following Tooth ExtractionPatients underwent surgery under local anesthesia and minimally invasive periotomy was carried out with a surgical blade. Atraumatic extraction with forceps was performed. The extraction socket was carefully curetted to remove the granulation tissue and was rinsed with a physiologic solution. To evaluate the eligibility of the surgical site, the alveolar walls integrity was checked clinically and by means of extemporaneous peri-apical radiography. Then, the socket was filled to the bone margin with Inion BioRestore™ (granules size 1 to 2 millimetres). Finally, single interrupted (5-0) sutures were tightened to promote the stability of grafted particles. Ten days after the surgery, sutures were removed. | Device | bioactive glass |
Primary outcome
Not reported in the source record.
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 16 Apr 2010.
- Derived from this study: PubMed 22848877Clozza E, Biasotto M, Cavalli F, Moimas L, Di Lenarda R. Three-dimensional evaluation of bone changes following ridge preservation procedures. Int J Oral Maxillofac Implants. 2012 Jul-Aug;27(4):770-5.
- Derived from this study: PubMed 22691124Clozza E, Pea M, Cavalli F, Moimas L, Di Lenarda R, Biasotto M. Healing of fresh extraction sockets filled with bioactive glass particles: histological findings in humans. Clin Implant Dent Relat Res. 2014 Feb;16(1):145-53. doi: 10.1111/j.1708-8208.2012.00463.x. Epub 2012 Jun 12.
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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 Phase 1 study testing Alveolar Bone Defect Regeneration Following Tooth Extraction in people with Alveolar Bone Loss, run by University of Trieste.
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 4 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 16 Apr 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01105026, which also lists 2 linked publications.
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 16 Apr 2010.