EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WI... | NCT02149758

Studies
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).

NCT02149758

Sponsor

Tatyasaheb Kore Dental College

Status

Completed

Last Update Posted

May 29, 2014Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Cyclooxygenase Two Inhibitors
Etoricoxib
Periodontitis
Superoxide Dismutase
Saliva

Interventions

Etoricoxib

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

May 26, 2014

First Submission Date that Met QC Criteria

May 26, 2014

First Posted Date

May 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2014

Last Update Posted Date

May 29, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Sumit Sharad Shetgar, BDS (Post graduate student, Tatyasaheb Kore Dental CollegePrincipal Investigator

Lead Sponsor

Tatyasaheb Kore Dental CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Etoricoxib	Experimental	Etoricoxib 60 mg once daily	Drug: Etoricoxib
matching placebo	Placebo Comparator	matching placebo once daily	Drug: Etoricoxib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etoricoxib	Drug		Etoricoxib matching placebo	Nucoxia Arcoxia

Measure	Description	Time Frame
change from baseline in salivary SOD level		3 months

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr.Sumit S. Shetgar, BDS	Tatyasaheb Kore Dental College And Research Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tatyasaheb kore Dental College And Research Centre		Kolhāpur	Maharashtra	416137	India

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

ID	Term
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds