Trial | NCT00529555  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Intervention/Treatment

    minocycline ...

  • Study Participants

    602
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 Started
Jan 31
2006
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Results Posted
May 09
2014
Estimate
Last Update
May 09
2014
Estimate

Drug minocycline HCl 2.1%

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

Procedure Scaling and root planing

scaling and root planing

  • Other names: SRP

Scaling and root planing + SHAM TX Sham Comparator

sham treatment

Scaling and root planing + Vehicle Placebo Comparator

Placebo

Scaling & root planing + Periocline Gel Active Comparator

Minocycline HCL 2.1%

Criteria 

Inclusion Criteria:

moderate to severe periodontitis

Exclusion Criteria:

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

Summary

Scaling and Root Planing + SHAM TX

Scaling & Root Planing + Periocline Gel

Scaling and Root Planing + Vehicle

All Events

Event Type Organ System Event Term Scaling and Root Planing + SHAM TX Scaling & Root Planing + Periocline Gel Scaling and Root Planing + Vehicle

Change in Pocket Depth.

Average change of Pocket Depth at 9 months from baseline

Scaling and Root Planing + SHAM TX

-1.4
mm (Least Squares Mean)
95% Confidence Interval: -1.7 to -1.1

Scaling and Root Planing + Periocline Gel

-1.6
mm (Least Squares Mean)
95% Confidence Interval: -1.8 to -1.3

Scaling and Root Planing + Vehicle

-1.4
mm (Least Squares Mean)
95% Confidence Interval: -1.7 to -1.1

Total

602
Participants

Age, Continuous

49.7
years (Mean)
Standard Deviation: 11.8

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Scaling and Root Planing + SHAM TX

Scaling & Root Planing + Periocline Gel

Scaling and Root Planing + Vehicle