Peri-ImplantitisNCT03213210
Efficacy of Synthetic Bone Graft for Treatment of Peri-implantitis
A study testing easy-graft CLASSIC (beta-Tricalcium Phosphate) in people with Peri-Implantitis, run by Sunstar Americas at 1 site in United States.
Trial summary
Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peri-Implantitis
- 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
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2018to 31 Jan 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has read and signed the Institutional Review Board approved consent form before treatment.
- Subject must be age 21 or above.
- Subject must be willing and able to follow study procedures and instructions.
- Subject affected by moderate to severe peri-implant disease.
- Treated chronic periodontitis and proper periodontal maintenance care.
- Dental implant must meet the following criteria to be selected for the study:
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- Implant presenting Probing Depth ≥ 6 mm
- Radiographic implant bone loss more than 25% of the implant length (Apex of the implant to implant platform) .
- Peri implant bone defect being a buccal dehiscence and semicircular bone resorption to the middle of the implant body, buccal dehiscence and circular bone resorption with lingual bone plate intact or circular bone resorption with buccal and lingual bone plates intact
- Single tooth implant restoration or implant supported fixed partial denture.
Who cannot join
- Subjects participating (currently or within 30 days prior to enrollment) in other clinical trials involving therapeutic intervention (either medical or dental).
- Subjects with poor oral hygiene as indicated by a score of greater than 50% on the O'Leary Plaque Index.
- Subjects with a systemic condition, which would preclude periodontal treatment, including but not limited to uncontrolled diabetes.
- Subjects with acute infectious lesions in the areas intended for treatment.
- Subjects taking chronic (i.e., > 2 weeks), therapeutic doses of medications known to affect bone metabolism such as nonsteroidal anti-inflammatory drugs or bisphosphonates. Prophylactic aspirin (≤ 325 mg q.d.) for cardiovascular indications will be permitted in subjects.
- Female subjects who are pregnant or lactating, or sexually-active female subjects who are of childbearing potential and are not using hormonal or barrier methods of birth control. (except for when a result of pregnancy test is negative)
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- Subjects who are on any chronic antibiotic or steroidal therapy.
- Smoker using more than 10 cigarettes or equivalent per day.
- Smoker using cigar, smokeless tobacco use or e-cigarette.
- Subjects diagnosed with drug induced gingival hyperplasia (e.g. calcium channel blockers).
- Subjects with radiographic evidence of pathology in other areas of the mouth besides implant area to be treated.
- Implant mobility.
- Subjects with parafunctional habits and not wearing bite guard.
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University School of Dentisty
Omaha, Nebraska, 68178
About this study
Official title: Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis
Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis.
- Conditions
- Peri-Implantitis
- Being tested
- easy-graft CLASSIC (beta-Tricalcium Phosphate)
- Medical subject headings
- Peri-Implantitis
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 the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.
| Study group | Role | What they receive |
|---|---|---|
| Device treatment | Other | 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 Probing Depth
Distance of probe penetration from gingival margin to bottom of peri-implant pocket
Measured: Change from baseline at 12 months after the surgery
Esthetic Satisfaction
To be assessed by examiner and subject using the Visual Analog Scales
Measured: At 12 months after the surgery
Secondary outcomes (3)
Change of Marginal Bone Level
Change of marginal bone level on periapical standardized radiographs from baseline.
Measured: Change from baseline at 6 and 12 months after the surgery
Change in Width of Keratinized Tissue
Distance between free gingival margin and mucogingival junction
Measured: Change from baseline at 6 and 12 months after the surgery
Change in Clinical Attachment Level
Distance of probe penetration from fixed reference to bottom of peri-implant
Measured: Change from baseline to at 6 and 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start12 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
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 Peri-ImplantitisStudies 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
- 5 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
- NCT03213210
- Sponsor's protocol ID
- CLP-2017-02-18-1
- Status last verified
- Mar 2021
- First submitted
- 7 Jul 2017
- Last updated
- 8 Apr 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Easy-graft CLASSIC for the Treatment of Peri-implantitis
- ClinicalTrials.gov ID
- NCT03213210
- Acronym / sponsor ID
- CLP-2017-02-18-1
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm study to evaluate the effectiveness of treatment approach using a new moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in peri-implantitis.
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 | Other | Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has read and signed the Institutional Review Board approved consent form before treatment.
- Subject must be age 21 or above.
- Subject must be willing and able to follow study procedures and instructions.
- Subject affected by moderate to severe peri-implant disease.
- Treated chronic periodontitis and proper periodontal maintenance care.
Key exclusion criteria (13 listed)
- Subjects participating (currently or within 30 days prior to enrollment) in other clinical trials involving therapeutic intervention (either medical or dental).
- Subjects with poor oral hygiene as indicated by a score of greater than 50% on the O'Leary Plaque Index.
- Subjects with a systemic condition, which would preclude periodontal treatment, including but not limited to uncontrolled diabetes.
- Subjects with acute infectious lesions in the areas intended for treatment.
- Subjects taking chronic (i.e., > 2 weeks), therapeutic doses of medications known to affect bone metabolism such as nonsteroidal anti-inflammatory drugs or bisphosphonates. Prophylactic aspirin (≤ 325 mg q.d.) for cardiovascular indications will be permitted in subjects.
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 the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant. | Device | Device treatment |
Primary outcome
Change in Probing Depth
Time frame: Change from baseline at 12 months after the surgery
Distance of probe penetration from gingival margin to bottom of peri-implant pocket
Esthetic Satisfaction
Time frame: At 12 months after the surgery
To be assessed by examiner and subject using the Visual Analog Scales
3 secondary outcomes
Change of Marginal Bone Level
Time frame: Change from baseline at 6 and 12 months after the surgery
Change in Width of Keratinized Tissue
Time frame: Change from baseline at 6 and 12 months after the surgery
Change in Clinical Attachment Level
Time frame: Change from baseline to at 6 and 12 months after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 CLASSIC (beta-Tricalcium Phosphate) in people with Peri-Implantitis, 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 10 inclusion and 13 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 8 Apr 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 23 Feb 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 Probing Depth (time frame: Change from baseline at 12 months after the surgery). The study lists 2 primary outcomes in all. 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 8 Apr 2021.