- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334405
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
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-
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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