Arestin - Use in Subjects With Peri-Implantitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OraPharma
ClinicalTrials.gov Identifier:
NCT01539564
First received: February 21, 2012
Last updated: June 25, 2014
Last verified: June 2014

February 21, 2012
June 25, 2014
April 2012
May 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 NCT01539564 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 ]
  • 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 ]
Not Provided
Not Provided
 
Arestin - Use in Subjects With Peri-Implantitis
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.

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.
 
Completed
215
June 2014
May 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 Kingdom,   United States,   Sweden,   Germany
 
NCT01539564
OP-P-5267
No
OraPharma
OraPharma
Not Provided
Principal Investigator: Thomas Flemmig, DMD, MBA University of Washington, School of Dentistry
OraPharma
June 2014

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