Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-30 @ 8:16 AM
Study NCT ID:
NCT04129957
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2019-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Failure of Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-21', 'size': 208905, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-10-14T03:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-17', 'studyFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of dental implants', 'timeFrame': 'up to 5 years follow-up', 'description': "The failure of implants was defined as the presence of peri-implantitis, presence of mobility of implants, or removal of the implants for any reasons, for instance, unacceptable performance in aspects of function, tissue physiology, esthetics, and patients' satisfaction after placement of suprastructure."}, {'measure': 'Follow-up time', 'timeFrame': 'up to 5 years follow-up', 'description': 'The follow-up time is defined as the difference in time between implant placement and implant failure, or the date of the last follow-up time point if the dental implant is in an acceptable state.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prediction', 'dental implants', 'failure', 'peri-implantitis'], 'conditions': ['Implant Complication', 'Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '23062125', 'type': 'BACKGROUND', 'citation': 'Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:22-38. doi: 10.1111/j.1600-0501.2012.02546.x.'}, {'pmid': '24660206', 'type': 'BACKGROUND', 'citation': 'Pjetursson BE, Asgeirsson AG, Zwahlen M, Sailer I. Improvements in implant dentistry over the last decade: comparison of survival and complication rates in older and newer publications. Int J Oral Maxillofac Implants. 2014;29 Suppl:308-24. doi: 10.11607/jomi.2014suppl.g5.2.'}, {'pmid': '23062124', 'type': 'BACKGROUND', 'citation': 'Jung RE, Zembic A, Pjetursson BE, Zwahlen M, Thoma DS. Systematic review of the survival rate and the incidence of biological, technical, and aesthetic complications of single crowns on implants reported in longitudinal studies with a mean follow-up of 5 years. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:2-21. doi: 10.1111/j.1600-0501.2012.02547.x.'}, {'pmid': '24103113', 'type': 'BACKGROUND', 'citation': 'Krebs M, Schmenger K, Neumann K, Weigl P, Moser W, Nentwig GH. Long-term evaluation of ANKYLOS(R) dental implants, part i: 20-year life table analysis of a longitudinal study of more than 12,500 implants. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e275-86. doi: 10.1111/cid.12154. Epub 2013 Sep 17.'}, {'pmid': '17100743', 'type': 'BACKGROUND', 'citation': 'Lekholm U, Grondahl K, Jemt T. Outcome of oral implant treatment in partially edentulous jaws followed 20 years in clinical function. Clin Implant Dent Relat Res. 2006;8(4):178-86. doi: 10.1111/j.1708-8208.2006.00019.x.'}, {'pmid': '22642261', 'type': 'BACKGROUND', 'citation': 'Ostman PO, Hellman M, Sennerby L. Ten years later. Results from a prospective single-centre clinical study on 121 oxidized (TiUnite) Branemark implants in 46 patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):852-60. doi: 10.1111/j.1708-8208.2012.00453.x. Epub 2012 May 29.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to identify predictors in patient profiles and implant characteristics and to develop and calibrate a prediction model for failure of implants. Patients' demographic characteristics, lifestyle habits, general health, dental health, and implant characteristics were regarded as potential predictors. The failure of implants and the follow-up time in days of implants were considered the outcome. Multivariate Cox proportional hazards regression analysis is used to find out the important risk factors for failure of dental implants and to develop the model for prediction of failure of dental implants at follow-up. The performance and clinical values of the model is determined.", 'detailedDescription': "During the past decades, dental implant therapy has developed into a successful treatment option for patients confronted with both partial and complete edentulism. Based on the literature, the survival rate of dental implants, which is defined that the dental implants are still in the mouth after insertion, is around 95% in the 5-year follow-up and around 90% in the 10-year follow-up. The success rate of dental implants, which is defined as dental implants in function, with good hard and soft tissue physiology and user satisfaction ranges from 85.2% to 88.7% in the follow-up of up to 20 years. This indicates that both the success rate and survival rate of dental implants is high. However, both survival rates and success rates vary across patients with different profiles. The expense of dental implant treatment is high and implant placement is a surgical procedure which is invasive and thus risky for the patients' health. Once the failure of dental implants occurs, it may cause some severe negative consequences for patients. For example, the failure will cause a financial loss for patients and a possible shock concerning both mental and physical aspects. To reduce these risks it is important and necessary for clinicians to be able to predict the risk of the failure of dental implants of individual patients before they undergo dental implant treatment.\n\nAim:\n\nThe aim of the project is to find out the possible risk factors for failure of dental implants and to develop a prediction model for the failure of dental implants at follow-up as a tool for clinicians to establish patients individual risk profile.\n\nMethods:\n\nThe study is a retrospective design. The clinical data of the adult patients who were referred to the Department of Oral Implantology and Prosthetic Dentistry, Academic Centre for Dentistry Amsterdam (ACTA) for placement of dental implants from September 2009 to September 2013 are collected retrospectively from the clinical data management system of ACTA in the study.\n\nThe potential predictors include five domains: patients' demographic characteristics, lifestyle habits, general health, dental health, and implant characteristics. These predictors are pre-screened by international experts in dental implantology based their clinical knowledge and experience.\n\nThe outcomes included the follow-up time of implants and whether the failure of the implants was observed at the follow-up. The follow-up time is defined as the difference in time between implant placement and implant failure, or the date of the last follow-up time point if the dental implant is in an acceptable state. The failure of implants is defined as the presence of peri-implantitis, presence of mobility of implants, or removal of the implants for any reasons, for instance, unacceptable performance in aspects of function, tissue physiology, esthetics, and patients' satisfaction after placement of suprastructure.\n\nThe Multivariate Cox proportional hazards regression analysis will be used to find out the important risk factors and to develop the model. The performance of the model, in aspects of calibration and discrimination, is assessed. The clinical added values of the model is assessed. Then, the model is transformed into a score chart and a line chart, which is easy-to-use to the clinicians for the prediction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The included patients were those who were referred to the Department of Oral Implantology and Prosthetic Dentistry, ACTA for placement of implant(s).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients were over 18 years old at baseline;\n* patients underwent the placement of at least one implant;\n* patients were followed up for the implants at least one time after placement of implants;\n* patients provided their informed consent.\n\nExclusion Criteria:\n\n* patients were \\<18 years old at baseline;\n* patients were not followed up;\n* patients did not provide the informed consent.'}, 'identificationModule': {'nctId': 'NCT04129957', 'briefTitle': 'Prediction of Failure of Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Academic Centre for Dentistry in Amsterdam'}, 'officialTitle': 'The Prediction of Failure Rate of Dental Implants', 'orgStudyIdInfo': {'id': '2018.376'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who underwent placement of dental implants', 'description': 'The study only includes one cohort. That is the patients who underwent placement of dental implants at baseline.', 'interventionNames': ['Procedure: Placement of dental implants']}], 'interventions': [{'name': 'Placement of dental implants', 'type': 'PROCEDURE', 'otherNames': ['No other intervention'], 'description': 'All the included patients underwent the placement of at least one implant in either upper jaw, or lower jaw, or both.', 'armGroupLabels': ['Patients who underwent placement of dental implants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081LA', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Centre for Dentistry in Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Geert van der Heijden, Prof. dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Academic Centre for Dentistry Amsterdam'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Starting 6 months after the publication. The data will be available for 15 years after the end of the study.', 'ipdSharing': 'YES', 'description': "The participants' clinical data and data on demographic characteristics are possible to be shared. But those data can be only used for research purpose.", 'accessCriteria': "The data can be shared upon researchers' request via email (n.su@acta.nl). Naichuan Su will review the requests. The researchers need to share their protocols and guarantee that the data is only used for research purpose."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academic Centre for Dentistry in Amsterdam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Naichuan Su', 'investigatorAffiliation': 'Academic Centre for Dentistry in Amsterdam'}}}}