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Active, Not Recruiting

NCT Number: NCT07334405

Dental Trauma - 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Trauma Fractures, Avulsion Fractures, Bone Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Pisa

Pisa, 56100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tooth replantation

Other

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

Primary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Incidence of complications

    Time frame: 2 weeks after trauma

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

  11. Incidence of complications

    Time frame: 4 weeks after trauma

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

  12. Incidence of complications

    Time frame: 3 months after trauma

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

  13. Incidence of complications

    Time frame: 6 months after trauma

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

  14. Incidence of complications

    Time frame: 12 months after trauma

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

  15. Incidence of complications

    Time frame: 24 months after trauma

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

  16. Incidence of complications

    Time frame: 36 months after trauma

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

  17. Incidence of complications

    Time frame: 48 months after trauma

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

  18. Incidence of complications

    Time frame: 60 months after trauma

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

Secondary outcomes

  1. Dental mobility

    Time frame: 2 weeks after trauma

    Tooth mobility clinically evaluated from 0 to 3

  2. Dental mobility

    Time frame: 4 weeks after trauma

    Tooth mobility clinically evaluated from 0 to 3

  3. Dental mobility

    Time frame: 3 months after trauma

    Tooth mobility clinically evaluated from 0 to 3

  4. Dental mobility

    Time frame: 6 months after trauma

    Tooth mobility clinically evaluated from 0 to 3

  5. Dental mobility

    Time frame: 12 months after trauma

    Tooth mobility clinically evaluated from 0 to 3

  6. Dental mobility

    Time frame: 24 months after trauma

    Tooth mobility clinically evaluated from 0 to 3

  7. Dental mobility

    Time frame: 36 months after trauma

    Tooth mobility clinically evaluated from 0 to 3

  8. Dental mobility

    Time frame: 48 months after trauma

    Tooth mobility clinically evaluated from 0 to 3

  9. Dental mobility

    Time frame: 60 months after trauma

    Tooth mobility clinically evaluated from 0 to 3

  10. Complication - root resorption

    Time frame: 2 weeks after trauma

    Radiographic signs of root resorption

  11. Complication - root resorption

    Time frame: 4 weeks after trauma

    Radiographic signs of root resorption

  12. Complication - root resorption

    Time frame: 3 months after trauma

    Radiographic signs of root resorption

  13. Complication - root resorption

    Time frame: 6 months after trauma

    Radiographic signs of root resorption

  14. Complication - root resorption

    Time frame: 12 months after trauma

    Radiographic signs of root resorption

  15. Complication - root resorption

    Time frame: 24 months after trauma

    Radiographic signs of root resorption

  16. Complication - root resorption

    Time frame: 36 months after trauma

    Radiographic signs of root resorption

  17. Complication - root resorption

    Time frame: 48 months after trauma

    Radiographic signs of root resorption

  18. Complication - root resorption

    Time frame: 60 months after trauma

    Radiographic signs of root resorption

  19. Complication - ankylosis

    Time frame: 2 weeks after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  20. Complication - ankylosis

    Time frame: 4 weeks after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  21. Complication - ankylosis

    Time frame: 3 months after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  22. Complication - ankylosis

    Time frame: 6 months after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  23. Complication - ankylosis

    Time frame: 12 months after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  24. Complication - ankylosis

    Time frame: 24 months after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  25. Complication - ankylosis

    Time frame: 36 months after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  26. Complication - ankylosis

    Time frame: 48 months after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  27. Complication - ankylosis

    Time frame: 60 months after trauma

    Clinical and radiographic signs of ankylosis (loss of periodontal space, absence of physiological tooth mobility)

  28. Extra-oral time

    Time frame: At baseline (toorh replantation after avulsion)

    Evaluated in minutes from the avulsion to the replantation

  29. Storage medium

    Time frame: At baseline (tooth replantation following avulsion)

    Storage medium of the avulsed tooth (milk, water, saline, etc)

  30. Alveolar fracture

    Time frame: At baseline (tooth replantation following avulsion)

    Presence of alveolar fractures associated to tooth avulsion

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2031
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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