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Effects of a Cyclic NSAID Regimen on Levels of Prostaglandin-E2 and Interleukin-1beta in Gingival Crevicular Fluid of Subjects with Periodontitis: A Randomised Clinical Trial

Effects of a Cyclic NSAID Regimen on Levels of Prostaglandin-E2 and Interleukin-1beta in Gingival Crevicular Fluid of Subjects with Periodontitis: A Randomised Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160202001
Enrollment
Unknown
Registered
2016-02-02
Start date
2000-01-08
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis Non&#45

Interventions

We evaluated the effect of a cyclic diclofenac potassium regimen on clinical parameters and levels of prostaglandin E2 (PGE2) and interleukin&#45
1 (IL&#45
1) in the gingival crevicular fluid (GCF) of subjects with periodontitis.,During the 6&#45
month&#44
randomized&#44
double&#45
blind&#44
placebo&#45
controlled study&#44
test (n = 28) and control (n = 13) groups were administered a cyclic regimen of diclofenac potassium (50 mg&#44
twice daily) or placebo.
Experimental Drug,Placebo Comparator Drug
diclofenac potassium ,placebo

Sponsors

Selcuk University,
Lead Sponsor
Novartis
Collaborator

Eligibility

Sex/Gender
All
Age
32 Years to 60 Years

Inclusion criteria

Inclusion criteria: Subjects were selected from a group of patients with moderate to chronic periodontal disease (at least two sites with loss of clinical attachment > 4mm and alveolar bone loss (ABL) of 30–50%, as judged by radiography).(they had less than 16 teeth in their mouth, at least four of which had a probing depth (PD) greater or equal to 5 mm, and radiographic evidence of Alveoler bone loss). Subjects had received initial periodontal therapy, including scaling and root planning (SRP), as well as oral hygiene instruction less than six weeks before study commencement.

Exclusion criteria

Exclusion criteria: (i) no history of cardiovascular disease, renal disease, bleeding in the upper gastrointestinal tract, gastrointestinal ulcers, asthma, hypersensitivity to diclofenac or other NSAIDs, prosthetic joint replacement, or other chronic disease affecting compliance; (ii) had not received antibiotics or antibacterial agents less than 6 months before study commencement; (iii) had not received NSAIDs within 1 month, or phenytoin or calcium antagonists within 3 months; (iii) no history of pregnancy, lactation, or inadequate birth control;

Design outcomes

Primary

MeasureTime frame
diclofenac potassium 6 months biochemical aanlysis—

Secondary

MeasureTime frame
diclofenac potassium 6 months clinical paarmeters—

Countries

Türkiye

Contacts

Public ContactNilgün Alptekin

DDS, PhD, Prof

noalptekin@baskent.edu.tr+90312215 1336

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026