Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-03 @ 3:38 PM
Study NCT ID:
NCT02846805
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2016-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Treatment of Implant-retained Mandibular Overdentures for 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-18', 'studyFirstSubmitDate': '2016-07-03', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'masticatory efficiency', 'timeFrame': 'three months after restoration of the implant-retained overdenture', 'description': 'masticatory efficiency will be measured with chwing-gum ,and the outcome will be analysed with the viewgum software'}], 'secondaryOutcomes': [{'measure': 'Oral health related quality of life', 'timeFrame': 'three months after restoration of the implant-retained overdenture', 'description': 'Oral health related quality of life will be measured with the Oral Health Impact Profile 14(OHIP-14).'}, {'measure': "patients' satisfaction", 'timeFrame': 'three months after restoration of the implant-retained overdenture', 'description': "patients' satisfaction will be assessed on visual analog scales (VAS)"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Edentulous']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate to what extent IOs improve the functionality of edentulous patients and changes in quality of life and overall patient satisfaction following treatment with IOs.', 'detailedDescription': 'Edentulous individuals will be selected from patients attending the prosthodontic clinic. Then, new complete dentures will be provided; in a second stage half of these subjects (randomly selected) will receive IOs. The effect of different treatment protocols on chewing ability, patient satisfaction and OHRQoL will be investigated and assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Being edentulous in the upper and lower jaw for at least 1 year\n2. Dissatisfied or cannot function with their complete lower denture\n3. Age between 40 and 75\n4. Suitable bone quality as assessed radiographically (CBCT) according to Zarb's classification。\n\nExclusion Criteria:\n\n1. Physical and mental disabilities which interfere with the maintenance of implants;\n2. Severe skeletal jaw discrepancies (class III)\n3. Those who have already received or lost dental implants\n4. Those who abuse drugs or alcohol\n5. Smoking more than 10 cigarettes a day\n6. Having received radiotherapy to the head and neck region for malignancies\n7. Undergoing chemotherapy\n8. On long-term therapy with steroids\n9. immunosuppressants or biphosphonates\n10. Insulin-dependent diabetic patients and uncontrolled onset diabetic patients\n11. Those affected by chronic renal or liver disease\n12. Systemic and local bone disorders and pathology\n13. Serious cardiac and pulmonary disorders\n14. Haemophilic disorders who are susceptible for increased bleeding and tendency for post-operative infections\n15. Those who are at risk of developing bacterial endocarditis\n16. Immune system compromised patients, including those with HIV"}, 'identificationModule': {'nctId': 'NCT02846805', 'acronym': 'TIMOEP', 'briefTitle': 'The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'A Clinical Trial on Conventional Dentures and Implant-retained Mandibular Overdentures With Respect to Oral Functionality and Quality of Life in Edentulous Patients', 'orgStudyIdInfo': {'id': 'IRB-REV-2016035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'complete dentures', 'description': 'complete dentures will be provided for all subjects according to the standardized treatment protocol'}, {'type': 'EXPERIMENTAL', 'label': 'implant-retained overdentures', 'description': 'subjects will receive two-implant-retained overdentures in the mandible ,and continue wearing their complete denture in the maxilla', 'interventionNames': ['Procedure: implant-retained overdentures']}], 'interventions': [{'name': 'implant-retained overdentures', 'type': 'PROCEDURE', 'description': 'subjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla.', 'armGroupLabels': ['implant-retained overdentures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chufan Ma', 'role': 'CONTACT', 'email': 'machufan@fmmu.edu.cn', 'phone': '+86 29 84776128'}], 'facility': 'Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Chufan Ma', 'role': 'CONTACT', 'email': 'machufan@fmmu.edu.cn', 'phone': '+86 29 84776128'}], 'overallOfficials': [{'name': 'Chufan Ma', 'role': 'STUDY_CHAIR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'secret'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chufan Ma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Chufan Ma', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}