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

Sunstar Americas602 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

602

Conditions

Adult Periodontitis

Interventions

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.

Scaling and root planingPROCEDURE

scaling and root planing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate to severe periodontitis Exclusion Criteria: * recent periodontal therapy * certain medical or dental conditions * pregnancy * allergy to active drug or related drugs

Locations (10)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California - San Francisco

San Francisco, California, United States

University of Florida

Gainsville, Florida, United States

Outcomes

Primary Outcomes

Change in Pocket Depth.

Average change of Pocket Depth at 9 months from baseline

Time frame: baseline & 9 months

Data from ClinicalTrials.gov

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