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Arestin - Use in Subjects With Peri-Implantitis

Information source: OraPharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peri-Implantitis

Intervention: Minocycline HCl Microspheres (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: OraPharma

Official(s) and/or principal investigator(s):
Thomas Flemmig, DMD, MBA, Principal Investigator, Affiliation: University of Washington, School of Dentistry

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.

Clinical Details

Official title: Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in mean Probing Depth of qualifying implant sites

Secondary outcome:

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

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

University of Dusseldorf, Poliklinik fur Zahnerhaltung, Parodontologie und Endodontologie, Dusseldorf 40225, Germany

Kristianstad University, Department of Periodontology, Kristianstad SE-291 88, Sweden

Eastman Dental Institute, University College of London, London WC1X 8LD, United Kingdom

UCLA School of Dentistry - Oral and Maxillofacial Surgery, Los Angeles, California 90095, United States

University of Florida College of Dentistry, Gainsville, Florida 32610, United States

Georgia Regents University, Augusta, Georgia 30912, United States

University of Maryland, School of Dentistry, Baltimore, Maryland 21201, United States

University of Minnesota - School of Dentistry, Minneapolis, Minnesota 55355, United States

University of North Carolina, General Oral Health Center, Chapel Hill, North Carolina 27599, United States

Ohio State University College of Dentistry, Columbus, Ohio 43210, United States

The Periodontal-Implant Institute, McLean, Virginia 22101, United States

University of Washington, School of Dentistry, Seattle, Washington 98195-7444, United States

Additional Information

Starting date: April 2012
Last updated: June 25, 2014

Page last updated: August 23, 2015

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