Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
OraPharma
ClinicalTrials.gov Identifier:
NCT01517334
First received: January 10, 2012
Last updated: April 7, 2014
Last verified: April 2014

January 10, 2012
April 7, 2014
May 2012
October 2014   (final data collection date for primary outcome measure)
Change in mean Probing Depth of qualifying implant sites [ Time Frame: Baseline to Day 180 ] [ Designated as safety issue: No ]
Reduction of Probing Depth [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
The primary efficacy measure is the reduction of probing depth from Baseline to Day 180 of qualifying implant sites.
Complete list of historical versions of study NCT01517334 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in proportions and numbers of the red-complex bacteria [ Time Frame: Baseline and Day 30 ] [ Designated as safety issue: No ]
  • Reduction of Bleeding on Probing [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
  • Reduction of Probing Depth and Bleeding on Probing [ Time Frame: Baseline and Day 90 ] [ Designated as safety issue: No ]
Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB) [ Time Frame: Baseline to Day 30 ] [ Designated as safety issue: No ]
Not Provided
 
Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peri-Implantitis
Drug: Minocycline HCl Microspheres
Other Name: Arestin (brand name)
  • 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.
    Intervention: Drug: Minocycline HCl Microspheres
  • No Intervention: Control
    Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
208
October 2014
October 2014   (final data collection date for primary outcome measure)

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)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517334
OP-P-5266-M
No
OraPharma
OraPharma
Not Provided
Principal Investigator: Steven Offenbacher, DDS University of North Carolina - Chapel Hill Dental School
OraPharma
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP