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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).

Sponsor
Tatyasaheb Kore Dental College (Other)
Overall Status
Completed
CT.gov ID
NCT02149758
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
5
Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal inflammation by:

  1. improving clinical periodontal parameters and,

  2. improving the salivary SOD levels.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Etoricoxib

Etoricoxib 60 mg once daily

Drug: Etoricoxib
Other Names:
  • Nucoxia
  • Arcoxia

    		•
    Placebo Comparator: matching placebo

    matching placebo once daily

    Drug: Etoricoxib
    Other Names:
  • Nucoxia
  • Arcoxia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change from baseline in salivary SOD level [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tatyasaheb kore Dental College And Research Centre Kolhapur Maharashtra India 416137

    Sponsors and Collaborators

    • Tatyasaheb Kore Dental College

    Investigators

    • Principal Investigator: Dr.Sumit S. Shetgar, BDS, Tatyasaheb Kore Dental College And Research Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Sumit Sharad Shetgar, BDS (Post graduate student, Tatyasaheb Kore Dental College
    ClinicalTrials.gov Identifier:
    NCT02149758
    Other Study ID Numbers:
    • sum2141
    First Posted:
    May 29, 2014
    Last Update Posted:
    May 29, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Dr. Sumit Sharad Shetgar, BDS (Post graduate student, Tatyasaheb Kore Dental College
    Cyclooxygenase two inhibitors
    Etoricoxib
    Periodontitis
    Superoxide dismutase
    Saliva
    Additional relevant MeSH terms:
    Periodontitis
    Etoricoxib

    Study Results

    No Results Posted as of May 29, 2014