Dental TraumaNCT07334405
Dental Trauma - Avulsion
An observational study of Dental Trauma, run by University of Pisa at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Trauma
- What is being tested?
- Tooth replantation
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2020to 20 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with absolute contraindications to dental replantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dental Trauma
- Being tested
- Tooth replantation
- Keywords
- trauma, avulsion, permanent tooth
- Medical subject headings
- Wounds and Injuries, Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth replantationOther
Avulsed teeth were replanted according to the International Academy of Dental Traumatology guidelines (IADT)
| Study group | Role | What they receive |
|---|---|---|
| Dental avulsion | Adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth Receives: Other: Tooth replantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth survival
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.
Measured: 2 weeks after trauma
Tooth survival
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.
Measured: 4 weeks after trauma
Tooth survival
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.
Measured: 3 months after trauma
Tooth survival
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.
Measured: 6 months after trauma
Tooth survival
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.
Measured: 12 months after trauma
Tooth survival
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.
Measured: 24 months after trauma
Tooth survival
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.
Measured: 36 months after trauma
Tooth survival
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.
Measured: 48 months after trauma
Tooth survival
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.
Measured: 60 months after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 2 weeks after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 4 weeks after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 3 months after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 6 months after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 12 months after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 24 months after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 36 months after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 48 months after trauma
Incidence of complications
Evaluated as presence/absence of a dental complication following trauma.
Measured: 60 months after trauma
Secondary outcomes (30)
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 2 weeks after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 4 weeks after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 3 months after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 6 months after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 12 months after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 24 months after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 36 months after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 48 months after trauma
Dental mobility
Tooth mobility clinically evaluated from 0 to 3
Measured: 60 months after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 2 weeks after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 4 weeks after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 3 months after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 6 months after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 12 months after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 24 months after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 36 months after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 48 months after trauma
Complication - root resorption
Radiographic signs of root resorption
Measured: 60 months after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 2 weeks after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 4 weeks after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 3 months after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 6 months after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 12 months after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 24 months after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 36 months after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 48 months after trauma
Complication - ankylosis
Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)
Measured: 60 months after trauma
Extra-oral time
Evaluated in minutes from the avulsion to the replantation
Measured: At baseline (toorh replantation after avulsion)
Storage medium
Storage medium of the avulsed tooth (milk, water, saline, etc)
Measured: At baseline (tooth replantation following avulsion)
Alveolar fracture
Presence of alveolar fractures associated to tooth avulsion
Measured: At baseline (tooth replantation following avulsion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start20 Nov 2020
- Primary completion20 Nov 2025
- Study completion20 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Barone, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334405
- Sponsor's protocol ID
- Dental Trauma - Tooth avulsion
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Therapeutic Approaches in Dental Traumatology: Management of Traumatic Tooth Avulsion
- ClinicalTrials.gov ID
- NCT07334405
- Acronym / sponsor ID
- Dental Trauma - Tooth avulsion
- Conditions
- Dental Trauma
- Keywords
- trauma, avulsion, permanent tooth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2031 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental avulsion | – | Other: Tooth replantationAdult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with absolute contraindications to dental replantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth replantationAvulsed teeth were replanted according to the International Academy of Dental Traumatology guidelines (IADT) | Other | Dental avulsion |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Incidence of complications
Time frame: 2 weeks after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 4 weeks after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 3 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 6 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 12 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 24 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 36 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 48 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
Incidence of complications
Time frame: 60 months after trauma
Evaluated as presence/absence of a dental complication following trauma.
30 secondary outcomes
Dental mobility
Time frame: 2 weeks after trauma
Dental mobility
Time frame: 4 weeks after trauma
Dental mobility
Time frame: 3 months after trauma
Dental mobility
Time frame: 6 months after trauma
Dental mobility
Time frame: 12 months after trauma
Dental mobility
Time frame: 24 months after trauma
Dental mobility
Time frame: 36 months after trauma
Dental mobility
Time frame: 48 months after trauma
Dental mobility
Time frame: 60 months after trauma
Complication - root resorption
Time frame: 2 weeks after trauma
Complication - root resorption
Time frame: 4 weeks after trauma
Complication - root resorption
Time frame: 3 months after trauma
Complication - root resorption
Time frame: 6 months after trauma
Complication - root resorption
Time frame: 12 months after trauma
Complication - root resorption
Time frame: 24 months after trauma
Complication - root resorption
Time frame: 36 months after trauma
Complication - root resorption
Time frame: 48 months after trauma
Complication - root resorption
Time frame: 60 months after trauma
Complication - ankylosis
Time frame: 2 weeks after trauma
Complication - ankylosis
Time frame: 4 weeks after trauma
Complication - ankylosis
Time frame: 3 months after trauma
Complication - ankylosis
Time frame: 6 months after trauma
Complication - ankylosis
Time frame: 12 months after trauma
Complication - ankylosis
Time frame: 24 months after trauma
Complication - ankylosis
Time frame: 36 months after trauma
Complication - ankylosis
Time frame: 48 months after trauma
Complication - ankylosis
Time frame: 60 months after trauma
Extra-oral time
Time frame: At baseline (toorh replantation after avulsion)
Storage medium
Time frame: At baseline (tooth replantation following avulsion)
Alveolar fracture
Time frame: At baseline (tooth replantation following avulsion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Trauma
Recruiting
Virtual Reality Distraction for Dental Anxiety (RCT)
Dental Anxiety, Dental Phobia
Active, not recruiting
Evaluation and Treatment of Crown Fractures Using the Modified Baysal Dental Trauma Index
Dental Trauma, Crown Fractures
Recruiting
Sport Mouthguards: Devices for Preventing Dental Injuries in Sports
Oral Health, Dental Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Trauma, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth survival (time frame: 2 weeks after trauma). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.