Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT02662361
Status:
UNKNOWN
Last Update Posted:
2016-05-06
First Post:
2016-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 131}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival of implants', 'timeFrame': 'at the first return visit（at least one year after restoration）', 'description': 'Time from the surgical placement of implants until the first return visit（at least one year after restoration）'}], 'secondaryOutcomes': [{'measure': 'Gingival Bleeding on Probing', 'timeFrame': 'at the first return visit（at least one year after restoration）', '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 return visit（at least one year after restoration）', 'description': 'Pocket depths measured around implants in millimeter (mm)'}, {'measure': 'Marginal bone loss', 'timeFrame': 'at the first return visit（at least one year after restoration）', 'description': 'Time from the surgical placement of implants until the first return visit（at least one year after restoration）'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['peri-implant disease; risk factors; prevalence'], 'conditions': ['Jaw, Edentulous, Partially']}, 'referencesModule': {'references': [{'pmid': '17092244', 'type': 'RESULT', 'citation': 'Ferreira SD, Silva GL, Cortelli JR, Costa JE, Costa FO. Prevalence and risk variables for peri-implant disease in Brazilian subjects. J Clin Periodontol. 2006 Dec;33(12):929-35. doi: 10.1111/j.1600-051X.2006.01001.x.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the patient-related 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': 'Objective: To investigate the patient-related 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. Methods:A total of 131 patients will enroll in the study. Univariate and multivariate logistic regression analysis is used to determine the patient factors associated with peri-implant disease. The variables include age, gender, smoking and alcohol consumption, presence of diabetes, cardiovascular disease, osteoporosis, bruxism, bleeding upon brushing, reason for extraction, oral hygiene and periodontal status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between January 2011 to May 2014.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients implanted at least one implant and restored with implant-supported fixed partial dentures and single crowns.\n\nThe implant-supported fixed partial dentures and single crowns were in function at least one year.\n\nExclusion Criteria:\n\nJaw radiotherapy treatment before and after implanting. Patients who have bruxism, xerostomia or the adjacent teeth periapical periodontitis.\n\nPatients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.\n\nPatients who suffered with mental and psychological disease will influence their oral health normal maintenance.'}, 'identificationModule': {'nctId': 'NCT02662361', 'briefTitle': 'Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'The Prevalence and Risk Factors for Patients With Peri-implant Disease：a Retrospective Study', 'orgStudyIdInfo': {'id': 'IRB-REV-2014027'}}, '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, 029-84776488', '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'}}}}