Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-13 @ 3:40 AM
Study NCT ID:
NCT02563457
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2015-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'fructosamine blood level', 'timeFrame': '3 weeks', 'description': 'Compare the fructosamine content in blood between the 2 groups'}, {'measure': 'Quality of life', 'timeFrame': '3 months', 'description': 'Compare the quality of life between the 2 groups using the 36-Item Short Form Health Survey (SF36)'}], 'primaryOutcomes': [{'measure': 'Hemoglobin A1c blood level', 'timeFrame': '3 months', 'description': 'efficacy of periodontal treatment on hemoglobin A1c'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic patients', 'periodontal treatment', 'glycaemic control'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '30136741', 'type': 'RESULT', 'citation': 'Vergnes JN, Canceill T, Vinel A, Laurencin-Dalicieux S, Maupas-Schwalm F, Blasco-Baque V, Hanaire H, Arrive E, Rigalleau V, Nabet C, Sixou M, Gourdy P, Monsarrat P; DIAPERIO Group. The effects of periodontal treatment on diabetic patients: The DIAPERIO randomized controlled trial. J Clin Periodontol. 2018 Oct;45(10):1150-1163. doi: 10.1111/jcpe.13003. Epub 2018 Sep 14.'}, {'pmid': '19646281', 'type': 'RESULT', 'citation': 'Vergnes JN, Arrive E, Gourdy P, Hanaire H, Rigalleau V, Gin H, Sedarat C, Dorignac G, Bou C, Sixou M, Nabet C. Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial. Trials. 2009 Aug 2;10:65. doi: 10.1186/1745-6215-10-65.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy of periodontal treatment in diabetic patient. Patients will be randomized in the periodontal group or in the control group. The control group will received a periodontal treatment after the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient suffering from a periodontitis\n* patient with : 7,0% \\< Hemoglobin A1c \\< 9,5%\n\nExclusion Criteria:\n\n* If an hospitalization is planned within the next 4 months\n* Patient suffering from chronic infectious pathology (HIV, hepatitis C virus, hepatitis B virus, mononucleosis)\n* Renal insufficiency\n* Contra indication for amoxicilline or clindamycin\n* Antithrombotic treatment\n* Liver disease'}, 'identificationModule': {'nctId': 'NCT02563457', 'acronym': 'DIAPERIO', 'briefTitle': 'Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients', 'orgStudyIdInfo': {'id': '08 031 08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'case', 'description': 'diabetic patients who will receive periodontal treatment blood sampling', 'interventionNames': ['Other: periodontal manual treatment']}, {'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'diabetic patients without periodontal treatment (no periodontal treatment) blood sampling', 'interventionNames': ['Other: no periodontal manual treatment']}], 'interventions': [{'name': 'periodontal manual treatment', 'type': 'OTHER', 'description': 'periodontal manual treatment', 'armGroupLabels': ['case']}, {'name': 'no periodontal manual treatment', 'type': 'OTHER', 'description': 'blood sampling', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'UH Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'UHToulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Michel Sixou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}