Cyclooxygenase Two InhibitorsPhase 4NCT02149758
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).
A Phase 4 study testing Etoricoxib in people with Cyclooxygenase Two Inhibitors and Etoricoxib, run by Tatyasaheb Kore Dental College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cyclooxygenase Two Inhibitors, Etoricoxib, Periodontitis
- What is being tested?
- Etoricoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
India1 site
Tatyasaheb kore Dental College And Research Centre
Kolhāpur, Maharashtra, 416137
About this study
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.
- Being tested
- Etoricoxib
- Keywords
- Cyclooxygenase two inhibitors, Etoricoxib, Periodontitis, Superoxide dismutase, Saliva
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called Nucoxia, Arcoxia
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib | Experimental | Etoricoxib 60 mg once daily Receives: Drug: Etoricoxib |
| matching placebo | Placebo comparator | matching placebo once daily Receives: Drug: Etoricoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in salivary SOD level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclooxygenase Two InhibitorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sumit Sharad Shetgar, Tatyasaheb Kore Dental College
- Investigators
- Dr.Sumit S. Shetgar, BDS, Principal investigator, Tatyasaheb Kore Dental College And Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149758
- Sponsor's protocol ID
- sum2141
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02149758
- Acronym / sponsor ID
- sum2141
- Keywords
- Cyclooxygenase two inhibitors, Etoricoxib, Periodontitis, Superoxide dismutase, Saliva
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib | Experimental | Drug: EtoricoxibEtoricoxib 60 mg once daily |
| matching placebo | Placebo comparator | Drug: Etoricoxibmatching placebo once daily |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoricoxibAlso: Nucoxia, Arcoxia | Drug | Etoricoxib, matching placebo |
Primary outcome
change from baseline in salivary SOD level
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Sumit S. Shetgar, BDS principal investigator
Tatyasaheb Kore Dental College And Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etoricoxib in people with Cyclooxygenase Two Inhibitors and Etoricoxib, run by Tatyasaheb Kore Dental College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in salivary SOD level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.