Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-04 @ 4:39 PM
Study NCT ID:
NCT03908606
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2019-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Hs-CRP in Periodontitis Patients With or Without Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2019-04-06', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical attachment level', 'timeFrame': '3 months', 'description': 'gain in clinical attachment level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Disease', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'the aim of this study was to assess serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy.', 'detailedDescription': 'Periodontitis and diabetes are chronic disorders with a two-way correlation as they can both stimulate an inflammatory response with subsequent formation of inflammatory mediators and cytokines. C reactive protein is an inflammatory plasma marker having a role in the systemic reaction to inflammation. thus, our aim in the current study was to evaluate serum levels of high sensitivity c reactive protein in periodontitis patients with and without type 2 diabetes in a trial to analyze its prognostic effect following non-surgical periodontal therapy. A total of 60 patients were enrolled in this study. ELISA was used for determination of hs- CRP. Non- surgical periodontal therapy was carried out for all periodontitis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetic patients type 2\n2. Periodontitis patients\n\nExclusion Criteria:\n\n1. Smokers\n2. Pregnant females'}, 'identificationModule': {'nctId': 'NCT03908606', 'briefTitle': 'Serum Hs-CRP in Periodontitis Patients With or Without Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prognostic Value of Serum Hs-CRP in Periodontitis Patients With or Without Type 2 Diabetes Following Non-surgical Periodontal Therapy', 'orgStudyIdInfo': {'id': '1281976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Periodontitis patients with diabetes type 2', 'description': 'scaling and root planing was administered to all patients. Serum samples were collected before and after treatment to assess hs-CRP levels. Glycated hemoglobin was measured before and after treatment', 'interventionNames': ['Procedure: Scaling and root planing']}, {'type': 'EXPERIMENTAL', 'label': 'Periodontitis patients', 'description': 'scaling and root planing will be done to periodontitis patients. Serum samples were collected before and after treatment to assess hs-CRP levels.', 'interventionNames': ['Procedure: Scaling and root planing']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy control group', 'description': 'We measured serum levels of hs-CRP in all healthy control subjects'}], 'interventions': [{'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'description': 'Supra and subgingival scaling and root planing.', 'armGroupLabels': ['Periodontitis patients', 'Periodontitis patients with diabetes type 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12411', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Gihane Madkour, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Gihane Gharib Madkour', 'investigatorAffiliation': 'Cairo University'}}}}