Effects of a Cyclic NSAID Regimen on Levels of GCF PGE-E2 and IL-1beta
Condition: Non-steroidal Anti-inflammatory Poisoning
MeSH terms: Poisoning
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Study Design This study utilized a randomized, controlled, double-blind, parallel-group
      design to investigate the 6-month effect of a cyclic regimen of diclofenac potassium [50 mg,
      twice daily (b.i.d)] on clinical parameters of periodontal disease and levels of PGE2 and
      IL-1beta in GCF. After clinical and radiographic examination, subjects were divided into two
      groups: 28 patients in the test group and 13 patients in the control group. Of the 28
      patients in the test group, ten (nine men, one woman) were smokers, eleven (six women, five
      men) were non-smokers, and seven (all men) were ex-smokers. Thirteen patients in the control
      group comprised six smokers (five men, one woman), five non-smokers (four women, one man) and
      two ex-smokers (both men).

      Test and control groups were administered either diclofenac potassium (50 mg) or placebo gel
      caps (containing inactive filler of starch flour and carboxymethylcellulose), respectively,
      b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium
      or placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or
      placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy
      was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was
      recalled monthly. Patients in both groups were instructed on oral hygiene, including tooth
      brushing for at least 2 minutes (b.i.d.) and daily interdental cleaning. SRP was not carried
      out during these recalls. During the screening period (baseline as well as 2, 4 and 6
      months), all subjects underwent physical examinations and biochemical analyses (blood
      chemistry, complete blood count, urinalyses and pregnancy testing).
    

Intervention name(s): cataflam (diclofenac potassium); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.; Placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen.
Administration of placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.
Other intervention name(s): Cataflam; placebo gel cap
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: periodontitis; anti-inflammatory agents