Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-05 @ 8:21 PM
Study NCT ID:
NCT02850458
Status:
UNKNOWN
Last Update Posted:
2017-02-07
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-04', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "patients' satisfaction", 'timeFrame': 'through study completion, an average of 1 year', 'description': "patients' satisfaction were assessed on visual analog scales (VAS)"}, {'measure': 'oral health-related quality of life', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Patients completed a 14-item Oral Health Impact Profile (OHIP-14) to assess oral health-related quality of life'}], 'primaryOutcomes': [{'measure': 'Survival of implants', 'timeFrame': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Gingival Bleeding on Probing', 'timeFrame': 'through study completion, an average of 1 year', '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': 'through study completion, an average of 1 year', 'description': 'Pocket depths measured around implants in millimeter (mm)'}, {'measure': 'Marginal bone loss', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Edentulous']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.', 'detailedDescription': "The survival of implants,condition of the peri-implant soft tissue were evaluated. And patients' perceptions regarding the outcome were assessed on visual analog scales (VAS), oral health impact profile-14 (OHIP) and semantic differential scale questionnaires."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with implant retained overdentures at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between July 2011 to May 2014.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients treated with implant retained overdentures\n2. With the ability to read and sign the informed consent document\n\nExclusion Criteria:\n\n1. Jaw radiotherapy treatment before and after implanting\n2. Patients who suffered with mental and psychological disease will influence their oral health normal maintenance\n3. Can not read and sign the informed consent document'}, 'identificationModule': {'nctId': 'NCT02850458', 'briefTitle': 'Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients: A 5-year Retrospective Study', 'orgStudyIdInfo': {'id': 'IRB-REV-2016036'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'implant retained-overdentures with the attachment of bar', 'description': 'patients treated with implant-retained overdentures,and the attachment is bar', 'interventionNames': ['Device: implant-retained overdentures']}, {'label': 'implant retained-overdentures with the attachment of magnet', 'description': 'patients treated with implant-retained overdentures,and the attachment is magnet', 'interventionNames': ['Device: implant-retained overdentures']}], 'interventions': [{'name': 'implant-retained overdentures', 'type': 'DEVICE', 'description': 'patients treated with an implant-retained overdenture in the mandible', 'armGroupLabels': ['implant retained-overdentures with the attachment of bar', 'implant retained-overdentures with the attachment of magnet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ji hua chen, PhD', 'role': 'CONTACT', 'email': 'jhchen@fmmu.edu.cn', 'phone': '029-84776329'}, {'name': 'huan zhou', 'role': 'CONTACT', 'email': 'zhouhuan113@126.com', 'phone': '029-84776128'}], 'facility': 'Stomatological Hospital of Fourth Military Medical University', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Ji hua chen, PhD', 'role': 'CONTACT', 'email': 'hchen@fmmu.edu.cn', 'phone': '029-84776329'}], 'overallOfficials': [{'name': 'Yong jin chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRB of Stomatological Hospital of FMMU,PLA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ji-hua Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_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'}}}}