NCT07334405

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
68mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Nov 2020Nov 2031

Study Start

First participant enrolled

November 20, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2031

Expected
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

December 18, 2025

Last Update Submit

January 5, 2026

Conditions

Dental Trauma

Keywords

traumaavulsionpermanent tooth

Outcome Measures

Primary Outcomes (18)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    60 months after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    2 weeks after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    4 weeks after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    3 months after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    6 months after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    12 months after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    24 months after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    36 months after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    48 months after trauma

  • Incidence of complications

    Evaluated as presence/absence of a dental complication following trauma.

    60 months after trauma

Secondary Outcomes (30)

  • Dental mobility

    2 weeks after trauma

  • Dental mobility

    4 weeks after trauma

  • Dental mobility

    3 months after trauma

  • Dental mobility

    6 months after trauma

  • Dental mobility

    12 months after trauma

  • +25 more secondary outcomes

Study Arms (1)

Dental avulsion

Adult and pediatric patients who experienced a traumatic avulsion of one or more permanent teeth

Other: Tooth replantation

Interventions

Tooth replantationOTHER

Avulsed teeth were replanted according to the International Academy of Dental Traumatology guidelines (IADT)

Dental avulsion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \- Patients with absolute contraindications to dental replantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Pisa

Pisa, Pisa, 56100, Italy

Location

MeSH Terms

Conditions

Wounds and InjuriesFractures, Avulsion

Interventions

Tooth Replantation

Condition Hierarchy (Ancestors)

Fractures, Bone

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeReplantationTransplantationEndodonticsDentistry

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 12, 2026

Study Start

November 20, 2020

Primary Completion

November 20, 2025

Study Completion (Estimated)

November 20, 2031

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)