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临床试验/NCT07334405
NCT07334405进行中(未招募)不适用

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

University of Pisa1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
13
试验地点
1
主要终点
Tooth survival

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - Patients with absolute contraindications to dental replantation

结局指标

主要结局

Tooth survival

时间窗: 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

时间窗: 60 months after trauma

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

Tooth survival

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

Incidence of complications

时间窗: 2 weeks after trauma

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

Incidence of complications

时间窗: 4 weeks after trauma

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

Incidence of complications

时间窗: 3 months after trauma

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

Incidence of complications

时间窗: 6 months after trauma

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

Incidence of complications

时间窗: 12 months after trauma

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

Incidence of complications

时间窗: 24 months after trauma

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

Incidence of complications

时间窗: 36 months after trauma

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

Incidence of complications

时间窗: 48 months after trauma

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

次要结局

  • Dental mobility(60 months after trauma)
  • Complication - root resorption(60 months after trauma)
  • Complication - ankylosis(60 months after trauma)
  • Extra-oral time(At baseline (toorh replantation after avulsion))
  • Storage medium(At baseline (tooth replantation following avulsion))
  • Alveolar fracture(At baseline (tooth replantation following avulsion))
  • 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)
  • Dental mobility(24 months after trauma)
  • Dental mobility(36 months after trauma)
  • Dental mobility(48 months after trauma)
  • Complication - root resorption(2 weeks after trauma)
  • Complication - root resorption(4 weeks after trauma)
  • Complication - root resorption(3 months after trauma)
  • Complication - root resorption(6 months after trauma)
  • Complication - root resorption(12 months after trauma)
  • Complication - root resorption(24 months after trauma)
  • Complication - root resorption(36 months after trauma)
  • Complication - root resorption(48 months after trauma)
  • Complication - ankylosis(2 weeks after trauma)
  • Complication - ankylosis(4 weeks after trauma)
  • Complication - ankylosis(3 months after trauma)
  • Complication - ankylosis(6 months after trauma)
  • Complication - ankylosis(12 months after trauma)
  • Complication - ankylosis(24 months after trauma)
  • Complication - ankylosis(36 months after trauma)
  • Complication - ankylosis(48 months after trauma)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Barone

Full Professor

University of Pisa

研究点 (1)

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