Alveolar Ridge PreservationNCT03215667
Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites
A study testing easy-graft CLASSIC (beta-Tricalcium Phosphate) in people with Alveolar Ridge Preservation and Dental Implants, run by Sunstar Americas at 1 site in United States.
Trial summary
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Ridge Preservation, Dental Implants
- What is being tested?
- easy-graft CLASSIC (beta-Tricalcium Phosphate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 3 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study
- minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)
- single-rooted tooth to be extracted
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- age >18 years old
- subjects who had >50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study
- adjacent teeth to extraction site will be present during healing period
- willingly sign informed consent and authorization.
Who cannot join
- do not meet any inclusion criteria
- pregnancy or nursing woman
- subjects with active systemic or localized infection (exclude chronic periodontitis)
- subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c>7%)
- subjects with smoking habit (more than 10 cigarettes per day)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
About this study
Official title: Ridge Preservation With Hardening Calcium Phosphate Bone Substitutes and Resorbable Membrane for Implant Site Development on Non-containable Extraction Sites: A Clinical and Histological Prospective Case Series in Humans
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.
- Conditions
- Alveolar Ridge Preservation, Dental Implants
- Being tested
- easy-graft CLASSIC (beta-Tricalcium Phosphate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
easy-graft CLASSIC (beta-Tricalcium Phosphate)Device
Also called GUIDOR Bioresorbable Matrix Barrier
easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
| Study group | Role | What they receive |
|---|---|---|
| Device treatment | Experimental | easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane Receives: Device: easy-graft CLASSIC (beta-Tricalcium Phosphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Radiographic Measurements of Bone Ridge Dimensions
Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.
Measured: Change from Baseline at 3 months
Secondary outcomes (1)
Change in Digital Measurements of Soft Tissue Dimensions
Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements.
Measured: Change from baseline at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Aug 2017
- Primary completion3 Nov 2019
- Study completion3 Nov 2019
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alveolar Ridge PreservationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunstar Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215667
- Sponsor's protocol ID
- CLP-2016-11-07-1
- Status last verified
- Jan 2021
- First submitted
- 10 Jul 2017
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation With Hardening Calcium Phosphate Bone Substitutes and Resorbable Membrane for Implant Site Development on Non-containable Extraction Sites: A Clinical and Histological Prospective Case Series in Humans
- ClinicalTrials.gov ID
- NCT03215667
- Acronym / sponsor ID
- CLP-2016-11-07-1
- Conditions
- Alveolar Ridge Preservation, Dental Implants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 3 Nov 2019 (actual)
- Study completion
- 3 Nov 2019 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Posted 25 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device treatment | Experimental | Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study
- minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)
- single-rooted tooth to be extracted
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- age >18 years old
Key exclusion criteria (5 listed)
- do not meet any inclusion criteria
- pregnancy or nursing woman
- subjects with active systemic or localized infection (exclude chronic periodontitis)
- subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c>7%)
- subjects with smoking habit (more than 10 cigarettes per day)
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 |
|---|---|---|
| easy-graft CLASSIC (beta-Tricalcium Phosphate)Also: GUIDOR Bioresorbable Matrix Barriereasy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions. | Device | Device treatment |
Primary outcome
Change in Radiographic Measurements of Bone Ridge Dimensions
Time frame: Change from Baseline at 3 months
Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.
1 secondary outcome
Change in Digital Measurements of Soft Tissue Dimensions
Time frame: Change from baseline at 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alveolar Ridge Preservation
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Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
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Vallomix Socket Preservation Study
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Different Approaches for Alveolar Ridge Preservation
Alveolar Ridge Resorption
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 easy-graft CLASSIC (beta-Tricalcium Phosphate) in people with Alveolar Ridge Preservation and Dental Implants, run by Sunstar Americas at 1 site in United States.
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 8 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: stopped early, as of the sponsor's last update on 25 Jan 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Radiographic Measurements of Bone Ridge Dimensions (time frame: Change from Baseline at 3 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 25 Jan 2021.