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

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: Active, not recruiting

Sponsored by: OraPharma

Official(s) and/or principal investigator(s):
Steven Offenbacher, DDS, Principal Investigator, Affiliation: University of North Carolina - Chapel Hill Dental School

Summary

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.

Clinical Details

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

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

Tufts University School of Dental Medicine, Boston, Massachusetts 02111, United States

University of Michigan - Michigan Center for Oral Health Research, Ann Arbor, Michigan 48106, United States

University of Missouri - Kansas City School of Dentistry Clinical Research Center, Kansas City, Missouri 64108, United States

University of North Carolina at Chapel Hill School of Dentistry, Chapel Hill, North Carolina 27599, United States

University of Pennsylvania School of Dental Medicine, Philadelphia, Pennsylvania 19104, United States

Medical University of South Carolina College of Dental Medicine, Charleston, South Carolina 29403, United States

UTHSC - College of Dentistry, Memphis, Tennessee 38163, United States

Virginia Commonwealth University School of Dentistry, Richmond, Virginia 98056, United States

Marquette University School of Dentstry, Milwaukee, Wisconsin 53233, United States

Additional Information

Starting date: May 2012
Last updated: April 7, 2014

Page last updated: August 23, 2015

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