Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 11:58 AM
Study NCT ID:
NCT07334405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Trauma - Avulsion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000071562', 'term': 'Fractures, Avulsion'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014090', 'term': 'Tooth Replantation'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012092', 'term': 'Replantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2031-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tooth survival', 'timeFrame': '2 weeks after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '4 weeks after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '3 months after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '6 months after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '12 months after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '24 months after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '36 months after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '48 months after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Tooth survival', 'timeFrame': '60 months after trauma', 'description': 'Tooth survival was defined as the presence of the tooth in the oral cavity at the time of follow-up. Tooth survival is assessed at each follow-up visit after replantation following the IADT guidelines.'}, {'measure': 'Incidence of complications', 'timeFrame': '2 weeks after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '4 weeks after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '3 months after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '6 months after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '12 months after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '24 months after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '36 months after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '48 months after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}, {'measure': 'Incidence of complications', 'timeFrame': '60 months after trauma', 'description': 'Evaluated as presence/absence of a dental complication following trauma.'}], 'secondaryOutcomes': [{'measure': 'Dental mobility', 'timeFrame': '2 weeks after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '4 weeks after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '3 months after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '6 months after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '12 months after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '24 months after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '36 months after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '48 months after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Dental mobility', 'timeFrame': '60 months after trauma', 'description': 'Tooth mobility clinically evaluated from 0 to 3'}, {'measure': 'Complication - root resorption', 'timeFrame': '2 weeks after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '4 weeks after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '3 months after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '6 months after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '12 months after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '24 months after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '36 months after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '48 months after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - root resorption', 'timeFrame': '60 months after trauma', 'description': 'Radiographic signs of root resorption'}, {'measure': 'Complication - ankylosis', 'timeFrame': '2 weeks after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '4 weeks after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '3 months after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '6 months after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '12 months after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '24 months after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '36 months after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '48 months after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Complication - ankylosis', 'timeFrame': '60 months after trauma', 'description': 'Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)'}, {'measure': 'Extra-oral time', 'timeFrame': 'At baseline (toorh replantation after avulsion)', 'description': 'Evaluated in minutes from the avulsion to the replantation'}, {'measure': 'Storage medium', 'timeFrame': 'At baseline (tooth replantation following avulsion)', 'description': 'Storage medium of the avulsed tooth (milk, water, saline, etc)'}, {'measure': 'Alveolar fracture', 'timeFrame': 'At baseline (tooth replantation following avulsion)', 'description': 'Presence of alveolar fractures associated to tooth avulsion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trauma', 'avulsion', 'permanent tooth'], 'conditions': ['Dental Trauma']}, 'descriptionModule': {'briefSummary': 'Dental traumatology is a field of dentistry , especially in pediatric age, but also in adulthood with permanent dentition. Dental trauma has a higher incidence in preschool, school-age, and adolescent patients, accounting for about 5% of injuries for which the intervention of a specialist physician is required. Traumatic avulsion of permanent teeth accounts up to 0.5-16% of all dental injuries and is considered one of the true emergencies in dentistry.The treatment of choice in case of traumatic avulsion of permanent teeth is the quickest-as-possible replantation. The primary objectives of this prospective study were to evaluate the incidence of complications and survival rates of replanted teeth over time. The secondary objectives were to assess and to examine the correlation between the development of complications and factors such as extra-oral time, storage media, root maturity and the presence of alveolar fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth and were treated at the University Hospital of Pisa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Adult and pediatric patients who experienced a dental trauma\n* Adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth\n* Patients treated with dental replantation following the International Association of Dental Traumatology (IADT) guidelines\n* Availability of clinical and radiographic follow-up for at least one year\n\nExclusion criteria\n\n\\- Patients with absolute contraindications to dental replantation'}, 'identificationModule': {'nctId': 'NCT07334405', 'briefTitle': 'Dental Trauma - Avulsion', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Prospective Study on Therapeutic Approaches in Dental Traumatology: Management of Traumatic Tooth Avulsion', 'orgStudyIdInfo': {'id': 'Dental Trauma - Tooth avulsion'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dental avulsion', 'description': 'Adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth', 'interventionNames': ['Other: Tooth replantation']}], 'interventions': [{'name': 'Tooth replantation', 'type': 'OTHER', 'description': 'Avulsed teeth were replanted according to the International Academy of Dental Traumatology guidelines (IADT)', 'armGroupLabels': ['Dental avulsion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56100', 'city': 'Pisa', 'state': 'Pisa', 'country': 'Italy', 'facility': 'University hospital of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Antonio Barone', 'investigatorAffiliation': 'University of Pisa'}}}}