Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
This study has been completed.
Sponsor:
OraPharma
Information provided by (Responsible Party):
OraPharma
ClinicalTrials.gov Identifier:
NCT01517334
First received: January 10, 2012
Last updated: August 25, 2015
Last verified: April 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Peri-Implantitis |
Drug: Minocycline HCl Microspheres |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by OraPharma:
Primary Outcome Measures:
- Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 180 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in percentage of qualifying implants with Bleeding On Probing [ Time Frame: Baseline to Day 180 ] [ Designated as safety issue: No ]
- Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 90 ] [ Designated as safety issue: No ]
- Change in percentage of qualifying implants with Bleeding on Probing [ Time Frame: Baseline to Day 90 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB) [ Time Frame: Baseline to Day 30 ] [ Designated as safety issue: No ]
| Enrollment: | 208 |
| Study Start Date: | May 2012 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517334
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517334
Locations
| 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 | |
Sponsors and Collaborators
OraPharma
Investigators
| Principal Investigator: | Steven Offenbacher, DDS | University of North Carolina - Chapel Hill Dental School |
More Information
| Responsible Party: | OraPharma |
| ClinicalTrials.gov Identifier: | NCT01517334 History of Changes |
| Other Study ID Numbers: | OP-P-5266-M |
| Study First Received: | January 10, 2012 |
| Last Updated: | August 25, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Peri-Implantitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases |
Minocycline Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 29, 2016