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Arestin - Use in Subjects With Peri-Implantitis

NCT01539564 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2014-06-26

No results posted yet for this study

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.

Conditions

  • Peri-Implantitis

Interventions

DRUG

Minocycline HCl Microspheres

Sponsors & Collaborators

  • OraPharma

    lead INDUSTRY

Principal Investigators

  • Thomas Flemmig, DMD, MBA · University of Washington, School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • United States
  • Germany
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539564 on ClinicalTrials.gov