Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-12 @ 5:45 AM
Study NCT ID:
NCT02014532
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2013-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}, {'id': 'D020024', 'term': 'Leukotriene Antagonists'}], 'ancestors': [{'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2013-12-17', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in the serum C- reactive protein levels at 3 weeks and 6 weeks', 'timeFrame': 'baseline, 3 weeks and 6 weeks', 'description': 'The biochemical parameter of serum C- reactive protein levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) the change in C- reactive protein levels was analysed.'}, {'measure': 'Changes from baseline in the probing pocket depth at 3 weeks and 6 weeks', 'timeFrame': 'baseline, 3 weeks and 6 weeks.', 'description': 'The probing pocket depths were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in probing pocket depth was analysed.'}, {'measure': 'Changes from baseline in the clinical attachment level at 3 weeks and 6 weeks.', 'timeFrame': 'baseline, 3 weeks and 6 weeks', 'description': 'The clinical attachment levels were checked at baseline, 3 weeks and 6 weeks. Montelukast therapy was started at baseline and continued for 3 weeks in test group and the post treatment levels were further checked at 6 weeks (i.e. 3 weeks after stoppage of Montelukast.) The change in clinical attachment levels was analysed.'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks', 'timeFrame': 'baseline, 3 weeks and 6 weeks', 'description': 'changes from baseline in standard clinical parameter, GI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. GI has a scoring criteria specified by Silness \\& Loe, 1963.'}, {'measure': 'Changes from baseline in Plaque Index (PI) at 3 weeks and 6 weeks', 'timeFrame': 'baseline, 3 weeks and 6 weeks', 'description': 'changes from baseline in standard clinical parameter, PI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PI has a scoring criteria specified by Loe \\& Silness, 1964.'}, {'measure': 'Changes from baseline in Oral Hygiene Index-Simplified (OHI-S) at 3 weeks and 6 weeks', 'timeFrame': 'baseline, 3 weeks and 6 weeks', 'description': 'changes from baseline in standard clinical parameter, OHI-S were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. OHI-S has a scoring criteria specified by Greene and Vermilion, 1964.'}, {'measure': 'Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks', 'timeFrame': 'baseline, 3 weeks and 6 weeks', 'description': 'changes from baseline in standard clinical parameter, SBI were assessed at 3 weeks after starting therapy with Montelukast, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. SBI has a scoring criteria specified by Muhleman (1971).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Leukotriene receptor antagonist', 'Chronic periodontitis', 'Scaling and root planing', 'C- reactive protein'], 'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and root planing in patients with chronic periodontitis leads to host inflammatory response modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open new vistas in treatment of chronic periodontitis.', 'detailedDescription': 'A RCT was carried out to check the efficacy of Montelukast as an adjunct to scaling and root planing. The patients were randomised to either test group (SRP + Montelukast) and control group (SRP). Clinical parameters were assessed at baseline, 3 weeks and 6 weeks. Serum C-reactive protein levels were assessed at baseline, 3 weeks and 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients within age group of 30 to 55 years.\n2. Systemically healthy individuals.\n3. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria\n\nExclusion Criteria:\n\n1. Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy),\n2. Smoking,\n3. Chronic alcoholics,\n4. Pregnancy or lactation,\n5. Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013,\n6. Confirmed or suspected intolerance to Montelukast,\n7. Periodontal therapy done within the January 2012 to Jun 2013.'}, 'identificationModule': {'nctId': 'NCT02014532', 'briefTitle': 'Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Tatyasaheb Kore Dental College'}, 'officialTitle': 'The Effect Of SRP With Adjunctive Systemic Therapy Of Leukotriene Receptor Antagonist-Montelukast On The Serum C Reactive Protein Levels & Clinical Parameters In Chronic Periodontitis Patients - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TKDC15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Montelukast', 'description': 'Patients in Test Group were given Leukotriene receptor antagonist, Montelukast 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.', 'interventionNames': ['Drug: Montelukast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in Control Group were given placebo drug 1 tablet twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Montelukast', 'type': 'DRUG', 'otherNames': ['Montair 10 mg (brand name)', 'Leukotriene receptor antagonist.'], 'description': 'Patients in Montelukast Group were treated with scaling and root planing (SRP) along with Montelukast (Montair 10mg), 1 tablet twice daily for 3 weeks.', 'armGroupLabels': ['Montelukast']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients in Placebo Group were treated with scaling and root planing (SRP) along with Placebo therapy, 1 tablet twice daily for 3 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '416137', 'city': 'Kolhāpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Tatyasaheb Kore Dental College and Research Centre, New Pargaon', 'geoPoint': {'lat': 16.69563, 'lon': 74.23167}}], 'overallOfficials': [{'name': 'Saurabh P Inamdar, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate student'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tatyasaheb Kore Dental College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr.Saurabh Inamdar', 'investigatorAffiliation': 'Tatyasaheb Kore Dental College'}}}}