Phase 3
N=602
Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
Adult Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT00529555 ↗Enrolled (actual)
602
Serious AEs
2.7%
Results posted
May 2014
Primary outcome: Primary: Change in Pocket Depth. — -1.4; -1.6; -1.4 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- minocycline HCl 2.1% (Drug); Scaling and root planing (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sunstar Americas
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pocket Depth. |
-1.4; -1.6; -1.4 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00529555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.