Peri-ImplantitisPhase 3NCT01539564
Arestin - Use in Subjects With Peri-Implantitis
A Phase 3 study testing Minocycline HCl Microspheres in people with Peri-Implantitis, run by OraPharma at 12 sites in 4 countries.
Trial summary
The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement. 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?
- Minocycline HCl Microspheres
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Apr 2012to Jun 2014
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A minimum of one osseointegrated implant with a diagnosis of peri-implantitis
- Absence of any significant oral soft tissue pathology
- At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing
- Confirmed evidence of pathologic bone loss
- At least 1mm of keratinized gingiva present around the implant
Who cannot join
- Pregnancy
- Allergy to tetracycline-class drug(s)
- Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures
- Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis
- Diagnosis of clinically significant or unstable organic disease, or compromised healing potential
- Signs of untreated advanced periodontal disease and/or poor oral hygiene
Show all 9Show fewer
- Subjects having a probing depth greater than 8mm at time of enrollment
- Subjects presenting with mobility of any dental implant
- Subjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States9 sites
Georgia Regents University
Augusta, Georgia, 30912
University of Maryland, School of Dentistry
Baltimore, Maryland, 21201
University of North Carolina, General Oral Health Center
Chapel Hill, North Carolina, 27599
Ohio State University College of Dentistry
Columbus, Ohio, 43210
University of Florida College of Dentistry
Gainsville, Florida, 32610
UCLA School of Dentistry - Oral and Maxillofacial Surgery
Los Angeles, California, 90095
The Periodontal-Implant Institute
McLean, Virginia, 22101
University of Minnesota - School of Dentistry
Minneapolis, Minnesota, 55355
University of Washington, School of Dentistry
Seattle, Washington, 98195-7444
Germany1 site
University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie
Düsseldorf, 40225
Sweden1 site
Kristianstad University, Department of Periodontology
Kristianstad, SE-291 88
United Kingdom1 site
Eastman Dental Institute, University College of London
London, WC1X 8LD
About this study
Official title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.
The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.
- Conditions
- Peri-Implantitis
- Being tested
- Minocycline HCl Microspheres
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline HCl MicrospheresDrug
Also called Arestin (brand name)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment (minocycline HCl microspheres, 1mg) administered at Baseline (following randomization) and Day 90 to qualifying implant sites, plus full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180. Receives: Drug: Minocycline HCl Microspheres |
| Control | No intervention | Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Probing Depth of qualifying implant sites
Measured: Baseline to Day 180
Secondary outcomes (3)
Change in percentage of qualifying implants with Bleeding on Probing
Measured: Baseline to Day 180
Change in mean Probing Depth of qualifying implant sites
Measured: Baseline to Day 90
Change in percentage of qualifying implants with Bleeding on Probing
Measured: Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- OraPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Flemmig, DMD, MBA, Principal investigator, University of Washington, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539564
- Sponsor's protocol ID
- OP-P-5267
- Status last verified
- Jun 2014
- First submitted
- 21 Feb 2012
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
- ClinicalTrials.gov ID
- NCT01539564
- Acronym / sponsor ID
- OP-P-5267
- Conditions
- Peri-Implantitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- OraPharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Feb 2012 (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 objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.
The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Minocycline HCl MicrospheresTreatment (minocycline HCl microspheres, 1mg) administered at Baseline (following randomization) and Day 90 to qualifying implant sites, plus full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180. |
| Control | No intervention | –Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A minimum of one osseointegrated implant with a diagnosis of peri-implantitis
- Absence of any significant oral soft tissue pathology
- At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing
- Confirmed evidence of pathologic bone loss
- At least 1mm of keratinized gingiva present around the implant
Key exclusion criteria (9 listed)
- Pregnancy
- Allergy to tetracycline-class drug(s)
- Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures
- Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis
- Diagnosis of clinically significant or unstable organic disease, or compromised healing potential
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 |
|---|---|---|
| Minocycline HCl MicrospheresAlso: Arestin (brand name) | Drug | Treatment |
Primary outcome
Change in mean Probing Depth of qualifying implant sites
Time frame: Baseline to Day 180
3 secondary outcomes
Change in percentage of qualifying implants with Bleeding on Probing
Time frame: Baseline to Day 180
Change in mean Probing Depth of qualifying implant sites
Time frame: Baseline to Day 90
Change in percentage of qualifying implants with Bleeding on Probing
Time frame: Baseline to Day 90
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 26 Jun 2014.
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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.
Thomas Flemmig, DMD, MBA principal investigator
University of Washington, School of Dentistry
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minocycline HCl Microspheres in people with Peri-Implantitis, run by OraPharma at 12 sites in 4 countries.
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 5 inclusion and 9 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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Sweden, United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Change in mean Probing Depth of qualifying implant sites (time frame: Baseline to Day 180). 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 26 Jun 2014.