Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-02-21 @ 12:13 AM
Study NCT ID:
NCT03043066
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2017-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum TRAP-5b Levels in Patients With Generalized 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': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-01', 'studyFirstSubmitDate': '2017-01-28', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum levels of TRAP-5b', 'timeFrame': 'Baseline and 3 months', 'description': 'Concentration of serum levels of TRAP-5b was assessed at baseline and at 3rd month using ELISA method.'}], 'secondaryOutcomes': [{'measure': 'Probing pocket depth', 'timeFrame': 'Baseline and 3 months', 'description': 'Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month'}, {'measure': 'Clinical attachment level', 'timeFrame': 'Baseline and 3 months', 'description': 'Clinical attachment level was measured as a distance between base of pocket and a fixed point on the crown, such as cemento-enamel junction at baseline and at 3rd month.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Periodontitis', 'TRAP-5b', 'Non-surgical periodontal therapy', 'Systemic antibiotics'], 'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '27027501', 'type': 'BACKGROUND', 'citation': 'Cosgarea R, Juncar R, Heumann C, Tristiu R, Lascu L, Arweiler N, Stavropoulos A, Sculean A. Non-surgical periodontal treatment in conjunction with 3 or 7 days systemic administration of amoxicillin and metronidazole in severe chronic periodontitis patients. A placebo-controlled randomized clinical study. J Clin Periodontol. 2016 Sep;43(9):767-77. doi: 10.1111/jcpe.12559. Epub 2016 Jun 23.'}, {'pmid': '25142259', 'type': 'BACKGROUND', 'citation': 'Keestra JA, Grosjean I, Coucke W, Quirynen M, Teughels W. Non-surgical periodontal therapy with systemic antibiotics in patients with untreated chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2015 Jun;50(3):294-314. doi: 10.1111/jre.12221. Epub 2014 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effect of non-surgical periodontal therapy with or without systemic administration of amoxicillin and metronidazole on the concentration of serum levels of TRAP-5b in patients with generalized chronic periodontitis.', 'detailedDescription': '30 Chronic periodontitis subjects were divided into two groups- group A underwent scaling and root planing and group B underwent scaling and root planing with systemic administration of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days.\n\nPeriodontal parameters probing pocket depth and clinical attachment level were measured at baseline and at 3rd month. Serum TRAP-5b levels were also measured at baseline, 1 month and at 3rd month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of atleast 20 teeth\n* more than 30% of sites with clinical attachment loss of ≥ 5 mm\n* non-smokers\n* no previous history of periodontal therapy\n\nExclusion Criteria:\n\n* systemic diseases\n* under antibiotics or anti-inflammatory drugs within previous 3 months\n* pregnant and lactating women\n* allergic to antibiotics'}, 'identificationModule': {'nctId': 'NCT03043066', 'briefTitle': 'Serum TRAP-5b Levels in Patients With Generalized Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Meenakshi Ammal Dental College and Hospital'}, 'officialTitle': 'The Effect of Non-surgical Periodontal Therapy With or Without Systemic Administration of Amoxicillin and Metronidazole on Serum Levels of TRAP-5b in Patients With Generalized Chronic Periodontitis - A Comparative Clinical Study', 'orgStudyIdInfo': {'id': 'MADC/IRB-IX/2016/193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A -control group', 'description': '15 subjects underwent scaling and root planing', 'interventionNames': ['Procedure: Scaling and root planing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B-Interventional group', 'description': '15 subjects underwent scaling and root planing along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days', 'interventionNames': ['Drug: scaling and root planing along with antibiotic intervention']}], 'interventions': [{'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'otherNames': ['Non-surgical periodontal therapy'], 'description': 'subjects underwent full mouth supragingival and subgingival scaling', 'armGroupLabels': ['Group A -control group']}, {'name': 'scaling and root planing along with antibiotic intervention', 'type': 'DRUG', 'otherNames': ['Systemic antibiotics'], 'description': 'subjects underwent full mouth supragingival and subgingival scaling along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days', 'armGroupLabels': ['Group B-Interventional group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sandhya CH, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meenakshi Ammal Dental College & Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meenakshi Ammal Dental College and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr.Jaideep Mahendra', 'investigatorAffiliation': 'Meenakshi Ammal Dental College and Hospital'}}}}