NCT02149758

Brief Summary

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

  1. 1.improving clinical periodontal parameters and,
  2. 2.improving the salivary SOD levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

May 26, 2014

Last Update Submit

May 26, 2014

Conditions

Keywords

Cyclooxygenase two inhibitorsEtoricoxibPeriodontitisSuperoxide dismutaseSaliva

Outcome Measures

Primary Outcomes (1)

  • change from baseline in salivary SOD level

    3 months

Study Arms (2)

Etoricoxib

EXPERIMENTAL

Etoricoxib 60 mg once daily

Drug: Etoricoxib

matching placebo

PLACEBO COMPARATOR

matching placebo once daily

Drug: Etoricoxib

Interventions

Also known as: Nucoxia, Arcoxia
Etoricoxibmatching placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tatyasaheb kore Dental College And Research Centre

Kolhāpur, Maharashtra, 416137, India

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dr.Sumit S. Shetgar, BDS

    Tatyasaheb Kore Dental College And Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BDS (Post graduate student

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations