Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-01-23 @ 7:23 AM
Study NCT ID:
NCT02676661
Status:
UNKNOWN
Last Update Posted:
2016-02-08
First Post:
2016-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2016-01-24', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peri-implant disease', 'timeFrame': 'at the 5 years after prosthetic loading.', 'description': 'Peri-implant disease includes Peri-implant mucositis and Peri-implantitis.Peri-implant mucositis: BoP/suppuration but no detectable bone loss. Peri-implantitis: BoP/suppuration and bone loss \\>2 mm.'}], 'secondaryOutcomes': [{'measure': 'Gingival Bleeding on Probing', 'timeFrame': 'at the first day,6 months 1,3 and 5 years after prosthetic loading.', 'description': 'Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.'}, {'measure': 'Pocket depths', 'timeFrame': 'at the first day,6 months 1,3 and 5 years after prosthetic loading.', 'description': 'PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm).'}, {'measure': 'Marginal bone loss', 'timeFrame': 'at the first day,6 months 1,3 and 5 years after prosthetic loading.', 'description': 'Marginal bone loss will be assessed by periapical radiographs taken with the paralleling technique.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['peri-implant disease', 'risk factors', 'prevalence'], 'conditions': ['Jaw, Edentulous, Partially']}, 'descriptionModule': {'briefSummary': 'To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.', 'detailedDescription': 'The aim of the present study is to identify the prevalence of peri-implant disease in partially edentulous subjects treated with osseointegrated implants, using clinical parameters, as well as to analyse the possible disease association with demographic, behavioural, and biological risk variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Partially edentulous patients implant dental implants and will be restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Partially edentulous patients will implant at least one implant and will be restored with implant-supported fixed partial dentures and single crowns.\n\nExclusion Criteria:\n\n* Jaw radiotherapy treatment before and after implanting. Patients who have bruxism,xerostomia or the adjacent teeth periapical periodontitis.\n* Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.\n* Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.'}, 'identificationModule': {'nctId': 'NCT02676661', 'briefTitle': 'Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'The Prevalence and Risk Factors for Patients With Peri-implant Disease： A Prospective Study', 'orgStudyIdInfo': {'id': 'Jhchen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no peri-implant disease', 'description': 'The subjects who did not suffer from peri-implant disease.'}, {'label': 'peri-implant disease', 'description': 'The subjects who suffered from peri-implant disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Tian, PhD', 'role': 'CONTACT', 'email': 'tianminno1@163.com', 'phone': '+86 13891862298'}, {'name': 'Jihua Chen, PhD', 'role': 'CONTACT', 'email': 'jhchen@fmmu.edu.cn', 'phone': '+86 13991390388'}, {'name': 'Min Tian, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Stomatological Hospital of Fourth Military Medical University', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Jihua Chen, PhD', 'role': 'CONTACT', 'email': 'jhchen@fmmu.edu.cn', 'phone': '029-84776329'}, {'name': 'Min Tian, PhD', 'role': 'CONTACT', 'email': 'tianminno1@163.com', 'phone': '029-84776129'}], 'overallOfficials': [{'name': 'Yongjin Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRB of Stomatological Hospital of FMMU,PLA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Dean of the Department of Prosthodontics, School of Stomatology, Fourth Military Medical University', 'investigatorFullName': 'Ji-hua Chen', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}