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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Italy
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Dental avulsion
Adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth
Other: Tooth replantation
Avulsed teeth were replanted according to the International Academy of Dental Traumatology guidelines (IADT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pisa

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dental Trauma - Tooth avulsion

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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