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EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).

Primary Purpose

Cyclooxygenase Two Inhibitors, Etoricoxib, Periodontitis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Etoricoxib
Sponsored by
Tatyasaheb Kore Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cyclooxygenase Two Inhibitors focused on measuring Cyclooxygenase two inhibitors, Etoricoxib, Periodontitis, Superoxide dismutase, Saliva

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Forty patients with chronic generalized periodontitis

-

Exclusion Criteria:with system illnesses, allergies, pregnancy, history of any drug intake and periodontal treatment in past 6 months.

Sites / Locations

  • Tatyasaheb kore Dental College And Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Etoricoxib

matching placebo

Arm Description

Etoricoxib 60 mg once daily

matching placebo once daily

Outcomes

Primary Outcome Measures

change from baseline in salivary SOD level

Secondary Outcome Measures

Full Information

First Posted
May 26, 2014
Last Updated
May 26, 2014
Sponsor
Tatyasaheb Kore Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT02149758
Brief Title
EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).
Official Title
EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal inflammation by: improving clinical periodontal parameters and, improving the salivary SOD levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyclooxygenase Two Inhibitors, Etoricoxib, Periodontitis, Superoxide Dismutase, Saliva
Keywords
Cyclooxygenase two inhibitors, Etoricoxib, Periodontitis, Superoxide dismutase, Saliva

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etoricoxib
Arm Type
Experimental
Arm Description
Etoricoxib 60 mg once daily
Arm Title
matching placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo once daily
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Other Intervention Name(s)
Nucoxia, Arcoxia
Primary Outcome Measure Information:
Title
change from baseline in salivary SOD level
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Forty patients with chronic generalized periodontitis - Exclusion Criteria:with system illnesses, allergies, pregnancy, history of any drug intake and periodontal treatment in past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Sumit S. Shetgar, BDS
Organizational Affiliation
Tatyasaheb Kore Dental College And Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tatyasaheb kore Dental College And Research Centre
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416137
Country
India

12. IPD Sharing Statement

Learn more about this trial

EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).

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