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COMPLETED Phase 3

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

NCT01517334 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Minocycline HCl Microspheres

Study Locations (10)

Maryland

  • University of Maryland, School of Dentistry — Baltimore

Massachusetts

  • Tufts University School of Dental Medicine — Boston

Michigan

  • University of Michigan - Michigan Center for Oral Health Research — Ann Arbor

Missouri

  • University of Missouri - Kansas City School of Dentistry Clinical Research Center — Kansas City

North Carolina

  • University of North Carolina at Chapel Hill School of Dentistry — Chapel Hill

Pennsylvania

  • University of Pennsylvania School of Dental Medicine — Philadelphia

South Carolina

  • Medical University of South Carolina College of Dental Medicine — Charleston

Tennessee

  • UTHSC - College of Dentistry — Memphis

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2012-05
Est. Completion 2014-11
Phase Phase 3

Sponsor

OraPharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01517334

The ClinicalTrials.gov registry entry for NCT01517334 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OraPharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Peri-Implantitis appearing as the primary indexed condition, and to 1 intervention — of which Minocycline HCl Microspheres is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01517334 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Maryland, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01517334 about?

NCT01517334 is a clinical study titled "Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)". 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 comb...

What is the current status of trial NCT01517334?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2012-05. Estimated completion is 2014-11.

What conditions does trial NCT01517334 study?

This clinical trial studies the following conditions: Peri-Implantitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01517334?

The interventions under investigation include: Minocycline HCl Microspheres (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01517334?

This trial is sponsored by OraPharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01517334 being conducted?

This trial has 10 study locations across Maryland, Massachusetts, Michigan, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial