drugset / Trial / NCT02658799

Effects of a Cyclic NSAID Regimen on Levels of GCF PGE-E2 and IL-1beta

NCT02658799

Phase 2 Completed 49 enrolled Baskent University
RandomizedParallel-groupDouble-blindTreatment

Summary

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and pain relief. However, while adjunct use of NSAIDs is avoided for periodontal therapy because of related side effects, cyclic administration of NSAIDs may reduce or eliminate these effects. The investigators evaluated the effect of a cyclic diclofenac potassium regimen on clinical parameters and levels of prostaglandin E2 (PGE2) and interleukin-1beta (IL-1beta) in the gingival crevicular fluid (GCF) of subjects with periodontitis. Forty-one subjects with moderate to chronic periodontitis (33 men, 8 women) were divided into two groups (test and control) after initial periodontal therapy. During this 6-month, randomized, double-blind, placebo-controlled study, test (n = 28) and control (n = 13) groups were administered a cyclic regimen of diclofenac potassium (50 mg, twice daily) or placebo. Clinical measurements of disease severity and GCF sample collections were made at baseline, 2, 4 and 6 months. GCF levels of PGE2 and IL1-1beta were determined using EIA and ELISA kits, respectively.

Timeline

Start
2000-01
Primary completion
2004-12
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Diclofenac Other / unclassified 50 mg

Indications