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Arestin - Use in Subjects With Peri-Implantitis

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Minocycline HCl Microspheres
Sponsored by
OraPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA School of Dentistry - Oral and Maxillofacial Surgery
  • University of Florida College of Dentistry
  • Georgia Regents University
  • University of Maryland, School of Dentistry
  • University of Minnesota - School of Dentistry
  • University of North Carolina, General Oral Health Center
  • Ohio State University College of Dentistry
  • The Periodontal-Implant Institute
  • University of Washington, School of Dentistry
  • University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie
  • Kristianstad University, Department of Periodontology
  • Eastman Dental Institute, University College of London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment

Outcomes

Primary Outcome Measures

Change in mean Probing Depth of qualifying implant sites

Secondary Outcome Measures

Change in percentage of qualifying implants with Bleeding on Probing
Change in mean Probing Depth of qualifying implant sites
Change in percentage of qualifying implants with Bleeding on Probing

Full Information

First Posted
February 21, 2012
Last Updated
June 25, 2014
Sponsor
OraPharma
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1. Study Identification

Unique Protocol Identification Number
NCT01539564
Brief Title
Arestin - Use in Subjects With Peri-Implantitis
Official Title
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OraPharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
Intervention Type
Drug
Intervention Name(s)
Minocycline HCl Microspheres
Other Intervention Name(s)
Arestin (brand name)
Primary Outcome Measure Information:
Title
Change in mean Probing Depth of qualifying implant sites
Time Frame
Baseline to Day 180
Secondary Outcome Measure Information:
Title
Change in percentage of qualifying implants with Bleeding on Probing
Time Frame
Baseline to Day 180
Title
Change in mean Probing Depth of qualifying implant sites
Time Frame
Baseline to Day 90
Title
Change in percentage of qualifying implants with Bleeding on Probing
Time Frame
Baseline to Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Flemmig, DMD, MBA
Organizational Affiliation
University of Washington, School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA School of Dentistry - Oral and Maxillofacial Surgery
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Florida College of Dentistry
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Maryland, School of Dentistry
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Minnesota - School of Dentistry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
University of North Carolina, General Oral Health Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University College of Dentistry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Periodontal-Implant Institute
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Facility Name
University of Washington, School of Dentistry
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-7444
Country
United States
Facility Name
University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Kristianstad University, Department of Periodontology
City
Kristianstad
ZIP/Postal Code
SE-291 88
Country
Sweden
Facility Name
Eastman Dental Institute, University College of London
City
London
ZIP/Postal Code
WC1X 8LD
Country
United Kingdom

12. IPD Sharing Statement

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Arestin - Use in Subjects With Peri-Implantitis

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