Dental Trauma - Avulsion

January 5, 2026 updated by: Antonio Barone, University of Pisa

Prospective Study on Therapeutic Approaches in Dental Traumatology: Management of Traumatic Tooth Avulsion

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pisa
      • Pisa, Pisa, Italy, 56100
        • University Hospital of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria

  • Adult and pediatric patients who experienced a dental trauma
  • Adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth
  • Patients treated with dental replantation following the International Association of Dental Traumatology (IADT) guidelines
  • Availability of clinical and radiographic follow-up for at least one year

Exclusion criteria

- Patients with absolute contraindications to dental replantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dental avulsion
Adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth
Avulsed teeth were replanted according to the International Academy of Dental Traumatology guidelines (IADT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth survival
Time Frame: 2 weeks after trauma
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.
2 weeks after trauma
Tooth survival
Time Frame: 4 weeks after trauma
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.
4 weeks after trauma
Tooth survival
Time Frame: 3 months after trauma
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.
3 months after trauma
Tooth survival
Time Frame: 6 months after trauma
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.
6 months after trauma
Tooth survival
Time Frame: 12 months after trauma
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.
12 months after trauma
Tooth survival
Time Frame: 24 months after trauma
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.
24 months after trauma
Tooth survival
Time Frame: 36 months after trauma
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.
36 months after trauma
Tooth survival
Time Frame: 48 months after trauma
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.
48 months after trauma
Tooth survival
Time Frame: 60 months after trauma
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.
60 months after trauma
Incidence of complications
Time Frame: 2 weeks after trauma
Evaluated as presence/absence of a dental complication following trauma.
2 weeks after trauma
Incidence of complications
Time Frame: 4 weeks after trauma
Evaluated as presence/absence of a dental complication following trauma.
4 weeks after trauma
Incidence of complications
Time Frame: 3 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
3 months after trauma
Incidence of complications
Time Frame: 6 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
6 months after trauma
Incidence of complications
Time Frame: 12 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
12 months after trauma
Incidence of complications
Time Frame: 24 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
24 months after trauma
Incidence of complications
Time Frame: 36 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
36 months after trauma
Incidence of complications
Time Frame: 48 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
48 months after trauma
Incidence of complications
Time Frame: 60 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
60 months after trauma

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental mobility
Time Frame: 2 weeks after trauma
Tooth mobility clinically evaluated from 0 to 3
2 weeks after trauma
Dental mobility
Time Frame: 4 weeks after trauma
Tooth mobility clinically evaluated from 0 to 3
4 weeks after trauma
Dental mobility
Time Frame: 3 months after trauma
Tooth mobility clinically evaluated from 0 to 3
3 months after trauma
Dental mobility
Time Frame: 6 months after trauma
Tooth mobility clinically evaluated from 0 to 3
6 months after trauma
Dental mobility
Time Frame: 12 months after trauma
Tooth mobility clinically evaluated from 0 to 3
12 months after trauma
Dental mobility
Time Frame: 24 months after trauma
Tooth mobility clinically evaluated from 0 to 3
24 months after trauma
Dental mobility
Time Frame: 36 months after trauma
Tooth mobility clinically evaluated from 0 to 3
36 months after trauma
Dental mobility
Time Frame: 48 months after trauma
Tooth mobility clinically evaluated from 0 to 3
48 months after trauma
Dental mobility
Time Frame: 60 months after trauma
Tooth mobility clinically evaluated from 0 to 3
60 months after trauma
Complication - root resorption
Time Frame: 2 weeks after trauma
Radiographic signs of root resorption
2 weeks after trauma
Complication - root resorption
Time Frame: 4 weeks after trauma
Radiographic signs of root resorption
4 weeks after trauma
Complication - root resorption
Time Frame: 3 months after trauma
Radiographic signs of root resorption
3 months after trauma
Complication - root resorption
Time Frame: 6 months after trauma
Radiographic signs of root resorption
6 months after trauma
Complication - root resorption
Time Frame: 12 months after trauma
Radiographic signs of root resorption
12 months after trauma
Complication - root resorption
Time Frame: 24 months after trauma
Radiographic signs of root resorption
24 months after trauma
Complication - root resorption
Time Frame: 36 months after trauma
Radiographic signs of root resorption
36 months after trauma
Complication - root resorption
Time Frame: 48 months after trauma
Radiographic signs of root resorption
48 months after trauma
Complication - root resorption
Time Frame: 60 months after trauma
Radiographic signs of root resorption
60 months after trauma
Complication - ankylosis
Time Frame: 2 weeks after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
2 weeks after trauma
Complication - ankylosis
Time Frame: 4 weeks after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
4 weeks after trauma
Complication - ankylosis
Time Frame: 3 months after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
3 months after trauma
Complication - ankylosis
Time Frame: 6 months after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
6 months after trauma
Complication - ankylosis
Time Frame: 12 months after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
12 months after trauma
Complication - ankylosis
Time Frame: 24 months after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
24 months after trauma
Complication - ankylosis
Time Frame: 36 months after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
36 months after trauma
Complication - ankylosis
Time Frame: 48 months after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
48 months after trauma
Complication - ankylosis
Time Frame: 60 months after trauma
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
60 months after trauma
Extra-oral time
Time Frame: At baseline (toorh replantation after avulsion)
Evaluated in minutes from the avulsion to the replantation
At baseline (toorh replantation after avulsion)
Storage medium
Time Frame: At baseline (tooth replantation following avulsion)
Storage medium of the avulsed tooth (milk, water, saline, etc)
At baseline (tooth replantation following avulsion)
Alveolar fracture
Time Frame: At baseline (tooth replantation following avulsion)
Presence of alveolar fractures associated to tooth avulsion
At baseline (tooth replantation following avulsion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

November 20, 2025

Study Completion (Estimated)

November 20, 2031

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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