Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01517334 |
Recruitment Status :
Completed
First Posted : January 25, 2012
Last Update Posted : August 26, 2015
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The objective of the study is to evaluate the safety, effectiveness and anti-microbial effects 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.
Condition or disease | Intervention/treatment | Phase |
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Peri-Implantitis | Drug: Minocycline HCl Microspheres | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 208 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
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Experimental: Treatment
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.
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Drug: Minocycline HCl Microspheres
Other Name: Arestin (brand name) |
No Intervention: Control
Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
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- Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 180 ]
- 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 ]
- Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB) [ Time Frame: Baseline to Day 30 ]

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517334
United States, Maryland | |
University of Maryland, School of Dentistry | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Tufts University School of Dental Medicine | |
Boston, Massachusetts, United States, 02111 | |
United States, Michigan | |
University of Michigan - Michigan Center for Oral Health Research | |
Ann Arbor, Michigan, United States, 48106 | |
United States, Missouri | |
University of Missouri - Kansas City School of Dentistry Clinical Research Center | |
Kansas City, Missouri, United States, 64108 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill School of Dentistry | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Pennsylvania | |
University of Pennsylvania School of Dental Medicine | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Medical University of South Carolina College of Dental Medicine | |
Charleston, South Carolina, United States, 29403 | |
United States, Tennessee | |
UTHSC - College of Dentistry | |
Memphis, Tennessee, United States, 38163 | |
United States, Virginia | |
Virginia Commonwealth University School of Dentistry | |
Richmond, Virginia, United States, 98056 | |
United States, Wisconsin | |
Marquette University School of Dentstry | |
Milwaukee, Wisconsin, United States, 53233 |
Principal Investigator: | Steven Offenbacher, DDS | University of North Carolina - Chapel Hill Dental School |
Responsible Party: | OraPharma |
ClinicalTrials.gov Identifier: | NCT01517334 |
Other Study ID Numbers: |
OP-P-5266-M |
First Posted: | January 25, 2012 Key Record Dates |
Last Update Posted: | August 26, 2015 |
Last Verified: | April 2014 |
Peri-Implantitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
Minocycline Anti-Bacterial Agents Anti-Infective Agents |