Effects of a Cyclic NSAID Regimen on Levels of GCF PGE-E2 and IL-1beta
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| ClinicalTrials.gov Identifier: NCT02658799 |
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Recruitment Status :
Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-steroidal Anti-inflammatory Poisoning | Drug: cataflam (diclofenac potassium) Drug: placebo | Phase 2 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 49 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Cyclic Regimen of Diclofenac Potassium May be Efficacious in the Management of Chronic Periodontitis in Adults |
| Study Start Date : | January 2000 |
| Actual Primary Completion Date : | December 2004 |
| Actual Study Completion Date : | December 2004 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: diclofenac potassium
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) was administered from 2 to 4 months, then diclofenac potassium therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. |
Drug: cataflam (diclofenac potassium)
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.
Other Name: Cataflam |
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Active Comparator: placebo
or 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 (placebo) was administered from 2 to 4 months, then diclofenac potassium therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. |
Drug: placebo
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 Name: placebo gel cap |
- Changes in gingival crevicular fluid levels of prostaglandin E2 by 50 mg diclofenac potassium administration [ Time Frame: Baseline, 2 months, 4 months and 6 months ]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. Gingival crevicular fluid levels of prostaglandin E2 was measured by using ELISA method, at baseline, 2-month, 4-month and 6-month of the study period.
- Changes in gingival crevicular fluid levels of interleukin-1beta by 50 mg diclofenac potassium administration [ Time Frame: Baseline, 2 months, 4 months and 6 months ]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. Gingival crevicular fluid levels of interleukin-1beta were measured by using ELISA method, at baseline, 2-month, 4-month and 6-month of the study period.
- Changes in plaque index (PI) by 50 mg diclofenac potassium administration [ Time Frame: Baseline, 2 months, 4 months and 6 months ]At baseline, 2-, 4- and 6-month, plaque index (PI) were recorded. Plaque index (PI); 0: no visible plaque, 1: minor plaque accumulation during probing, 2: visible plaque near by gingiva, 3: full plaque accumulation of the tooth.
- Changes in gingival index (GI) by 50 mg diclofenac potassium administration [ Time Frame: Baseline, 2 months, 4 months and 6 months ]At baseline, 2-, 4- and 6-month, gingival index (GI) were recorded. Gingival index (GI); 0: healthy gingiva, 1: slightly inflammation and no bleeding on probing, 2: moderate gingival inflammation and bleeding on probing, 3: spontaneous bleeding and/or suppuration.
- Changes in probing depth (PD) by 50 mg diclofenac potassium administration [ Time Frame: Baseline, 2 months, 4 months and 6 months ]At baseline, 2-, 4- and 6-month, probing depth (PD) were recorded. Probing depth (PD): with William's periodontal probe, distance between gingival margin to bottom of the sulcus).
- Changes in probing clinical attachment level by 50 mg diclofenac potassium administration [ Time Frame: Baseline, 2 months, 4 months and 6 months ]At baseline, 2-, 4- and 6-month, clinical attachment level (CAL) were recorded. Clinical attachment level (CAL); with William's periodontal probe, distance between enamel-cement junction to bottom of the sulcus).
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| Ages Eligible for Study: | 32 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- with moderate to chronic periodontal disease
- (at least two sites with loss of clinical attachment > 4mm
- alveolar bone loss of 30-50%, as judged by radiography
- received initial periodontal therapy, including scaling and root planning, as well as oral hygiene instruction less than six weeks before study commencement.
Exclusion Criteria:
- 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
- received antibiotics or antibacterial agents less than 6 months before study commencement
- received NSAIDs within 1 month, or phenytoin or calcium antagonists within 3 months
- history of pregnancy, lactation, or inadequate birth control
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658799
| Principal Investigator: | Bahar Füsun Oduncuoğlu, DDSPhD | Baskent University |
| Responsible Party: | Nilgün Özlem Alptekin, DDS, PhD, Prof, Baskent University |
| ClinicalTrials.gov Identifier: | NCT02658799 |
| Other Study ID Numbers: |
2000/071 |
| First Posted: | January 20, 2016 Key Record Dates |
| Last Update Posted: | January 20, 2016 |
| Last Verified: | January 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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periodontitis anti-inflammatory agents |
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Poisoning Chemically-Induced Disorders Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |