Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-07 @ 9:30 PM
Study NCT ID:
NCT02464202
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of CBCT-based Tooth Replica in Tooth Autotransplantation to Improve the Outcome of Tooth Replacement in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2015-06-02', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate', 'timeFrame': '5 years'}, {'measure': 'survival rate', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tooth autotransplantation', 'stereolithography tooth replica', 'CBCT', 'Outcome'], 'conditions': ['Increase Success Rate of Tooth Transplantation']}, 'referencesModule': {'references': [{'pmid': '30786806', 'type': 'DERIVED', 'citation': 'EzEldeen M, Wyatt J, Al-Rimawi A, Coucke W, Shaheen E, Lambrichts I, Willems G, Politis C, Jacobs R. Use of CBCT Guidance for Tooth Autotransplantation in Children. J Dent Res. 2019 Apr;98(4):406-413. doi: 10.1177/0022034519828701. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study lies in comparing the outcome of the proposed technique in a large sample size group to the outcome of the conventional tooth autotransplantation method and to provide sufficient evidence for improving the long-term success rate of the tooth autotransplantation procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe subjects will be divided in two groups according to different surgical protocols.\n\n1. Pediatric subjects (age between 9-18 years) treated with the CBCT-based replica procedure (prospective approach).\n\n Pediatric subjects (N=50) that missed their teeth due to agenesis or lost their permanent teeth due to trauma, caries, and endodontic failure and referred to dentistry department for replacement of the missing tooth by means of tooth autotransplantation.\n2. Pediatric subjects (age between 9-18 years) treated with the conventional method (prospective and retrospective).\n\nPediatric subjects (N=50) that missed their teeth due to agenesis or lost their permanent teeth due to trauma, caries, and endodontic failure and referred to dentistry department for replacement of the missing tooth by means of tooth autotransplantation.\n\nA matched control patient will be selected with the focus on a very similar surgical challenge, based on age, gender and a matching donor tooth with the same stage of root development and host bed.\n\nExclusion Criteria:\n\n* Potential participants (case and control) will be excluded if follow-up data are missing for the one-year follow-up.'}, 'identificationModule': {'nctId': 'NCT02464202', 'briefTitle': 'Use of CBCT-based Tooth Replica in Tooth Autotransplantation to Improve the Outcome of Tooth Replacement in Children', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Use of Stereolithographic Model in Tooth Autotransplantation and Periodontal Ligament Stem Cells for Pulp Revascularization and Reinnervation to Increase the Success Rate for Tooth Replacement in Children', 'orgStudyIdInfo': {'id': 'G089213N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stereolithography tooth replica', 'description': 'stereolithographic tooth replica used as a guide for tooth autotransplantation decreases extra-alveolar time and reduces trauma to periodontal ligament tissue therefore increasing the success rate after transplantation', 'interventionNames': ['Other: stereolithography tooth replica']}], 'interventions': [{'name': 'stereolithography tooth replica', 'type': 'OTHER', 'description': 'Tooth replica will be made and used for preparing the receiving tooth socket during autotransplantation', 'armGroupLabels': ['stereolithography tooth replica']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'KULeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient is already informed and in follow-up after the surgery.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Foundation Flanders', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Reinhilde Jacobs', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}