PeriodontologyNCT02221557
Case Series of New Alloplastic Bone Graft Material
A study testing easy-graft (beta-Tricalcium Phosphate) in people with Periodontology and Oral Surgery, run by Sunstar Americas at 1 site in United States.
Trial summary
A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periodontology, Oral Surgery
- What is being tested?
- easy-graft (beta-Tricalcium Phosphate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have read, understood and signed a consent form.
- 18-75 years of age
- Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.
Who cannot join
- Active caries or endodontic lesions in adjacent teeth
- Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)
- Taking any medication known for gingival hyperplasia for past 3 months.
- Any systemic contraindications to surgery
- Subject smokes > 10 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
About this study
Official title: Clinical and Histomorphometric Evaluation of Beta-tricalcium Phosphate/Polylactide Bone Substitute for Socket Preservation
A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.
- Conditions
- Periodontology, Oral Surgery
- Being tested
- easy-graft (beta-Tricalcium Phosphate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
easy-graft (beta-Tricalcium Phosphate)Device
| Study group | Role | What they receive |
|---|---|---|
| New alloplastic bone graft material | Experimental | Not described Receives: Device: easy-graft (beta-Tricalcium Phosphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Radiographic Measurement of Alveolar Ridge Height
Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
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 PeriodontologyStudies 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
- 8 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
- NCT02221557
- Sponsor's protocol ID
- 2014-7-1-1
- Status last verified
- Jul 2017
- First submitted
- 14 Aug 2014
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histomorphometric Evaluation of Beta-tricalcium Phosphate/Polylactide Bone Substitute for Socket Preservation
- ClinicalTrials.gov ID
- NCT02221557
- Acronym / sponsor ID
- 2014-7-1-1
- Conditions
- Periodontology, Oral Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New alloplastic bone graft material | Experimental | Device: easy-graft (beta-Tricalcium Phosphate) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have read, understood and signed a consent form.
- 18-75 years of age
- Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.
Key exclusion criteria (5 listed)
- Active caries or endodontic lesions in adjacent teeth
- Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)
- Taking any medication known for gingival hyperplasia for past 3 months.
- Any systemic contraindications to surgery
- Subject smokes > 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 (beta-Tricalcium Phosphate) | Device | New alloplastic bone graft material |
Primary outcome
Percentage Change in Radiographic Measurement of Alveolar Ridge Height
Time frame: Change from baseline to 6 months
Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 (beta-Tricalcium Phosphate) in people with Periodontology and Oral Surgery, 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 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 10 Aug 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 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 10 Aug 2017). 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?
Percentage Change in Radiographic Measurement of Alveolar Ridge Height (time frame: Change from baseline to 6 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 10 Aug 2017.