Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT02149758
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2014-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
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).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077613', 'term': 'Etoricoxib'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-26', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-05-26', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in salivary SOD level', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cyclooxygenase two inhibitors', 'Etoricoxib', 'Periodontitis', 'Superoxide dismutase', 'Saliva'], 'conditions': ['Cyclooxygenase Two Inhibitors', 'Etoricoxib', 'Periodontitis', 'Superoxide Dismutase', 'Saliva']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal inflammation by:\n\n1. improving clinical periodontal parameters and,\n2. improving the salivary SOD levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Forty patients with chronic generalized periodontitis\n\n\\-\n\nExclusion Criteria:with system illnesses, allergies, pregnancy, history of any drug intake and periodontal treatment in past 6 months.'}, 'identificationModule': {'nctId': 'NCT02149758', 'briefTitle': '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).', 'organization': {'class': 'OTHER', 'fullName': 'Tatyasaheb Kore Dental College'}, 'officialTitle': '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).', 'orgStudyIdInfo': {'id': 'sum2141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoricoxib', 'description': 'Etoricoxib 60 mg once daily', 'interventionNames': ['Drug: Etoricoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'matching placebo', 'description': 'matching placebo once daily', 'interventionNames': ['Drug: Etoricoxib']}], 'interventions': [{'name': 'Etoricoxib', 'type': 'DRUG', 'otherNames': ['Nucoxia', 'Arcoxia'], 'armGroupLabels': ['Etoricoxib', 'matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '416137', 'city': 'Kolhāpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Tatyasaheb kore Dental College And Research Centre', 'geoPoint': {'lat': 16.69563, 'lon': 74.23167}}], 'overallOfficials': [{'name': 'Dr.Sumit S. Shetgar, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tatyasaheb Kore Dental College And Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tatyasaheb Kore Dental College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BDS (Post graduate student', 'investigatorFullName': 'Dr. Sumit Sharad Shetgar', 'investigatorAffiliation': 'Tatyasaheb Kore Dental College'}}}}