Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis

Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

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Key information

Conditions

Adult Periodontitis Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

moderate to severe periodontitis

Exclusion criteria

recent periodontal therapy
certain medical or dental conditions
pregnancy
allergy to active drug or related drugs

Treatment and study plan

minocycline HCl 2.1%

Drug

Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.

Other names: periocline

Scaling and Root Planing

Procedure

scaling and root planing

Other names: SRP

Primary outcomes

Change in Pocket Depth.

Time frame: baseline & 9 months

Average change of Pocket Depth at 9 months from baseline

Sponsors and collaborators

Lead sponsor

Sunstar Americas

Industry

Registry information

Official study title

A 9 Month,3-arm Multicenter Clinical Trial of Treatment With Periocline Gel (2.1% Minocycline HCl) for Adjunctive Use to Scaling and Root Planing (SRP) in Adults With Periodontal Disease.

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Sep 14, 2007
Registry last updated: May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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