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临床试验/NCT04000854
NCT04000854Unknown不适用

Regenerative Treatment of Traumatized Immature Permanent Incisors With Pulp Necrosis: A Prospective Randomized Multicenter Study

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年2月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
Apical periodontitis

研究概览

简要总结

Endodontic management of traumatized immature permanent teeth with pulp necrosis is both a clinical challenge for the dental practitioners and a public health care problem. Even though there are feasible treatment procedures (such as apexification with calcium hydroxide and with Mineral Trioxide Aggregate (MTA), the long-term survival of these teeth is questionable because none of these techniques can provide continuation of root formation and thickening of the dentin walls. As a result, the immature tooth is weak and prone to fracture.

Recently, regenerative endodontic procedures have gained much attention as biologically based treatment alternative to the techniques described above, but the scientific evidence is insufficient. These procedures aim to remove necrotic and damaged tissues and replace those with healthy functioning pulp-dentin complex.

We plan to invite 120 patients to participate in this study. The inclusion criteria will be children between the ages of 7-19 years with traumatized permanent incisors with immature roots and open apices and pulp necrosis. Patients will be recruited from specialist clinics in Stockholm, Västerbotten and Norrbotten. The patients will be treated by specialists in endodontics and pediatric dentistry with regenerative endodontics. During a 5-year follow-up period the most important outcomes are continuous root development and healing of pulp necrosis. Severe traumatic dental injuries leading to severe complication that could result in early tooth loss can have a severe impact on oral health related quality of life. Therefore, regenerative endodontics can have beneficial effect treating these teeth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Traumatized permanent incisors with immature roots and open apices
  • pulp necrosis and apical periodontitis (if present)
  • No history of received endodontic treatment of the particular tooth
  • Pulp space not needed for post or core restoration
  • Good compliance of patient and parents
  • Ages from 7-19 years and both genders

排除标准

  • Traumatized permanent incisors with mature roots with closed apices (< 1 mm)
  • Retreatment cases
  • Marginal periodontitis
  • Root fracture
  • Intraoperative factors such as: lack of bleeding from the periapical tissue, exudate in the root canal prior to revascularization
  • Allergy to medicaments used for the treatment

研究组 & 干预措施

Calcium hydroxide

Active Comparator

Root canal dressing with Ca(OH)2 (Calasept)

干预措施: Calcium hydroxide (Calacept) (Drug)

Chlorhexidine

Active Comparator

Root canal dressing with clorhexidine digluconate 2 % gel

干预措施: Calcium hydroxide (Calacept) (Drug)

结局指标

主要结局

Apical periodontitis

时间窗: Change from baseline radiograph at 12 months

Presence of apical periodontitis on radiographs after intervention using PeriApicalIndex (PAI).(1) Normal periapical structure; (2) small changes in bone struc- ture; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features.

Root development

时间窗: Change from baseline radiograph at 12 months

Continous root development after on radiographs after intervention

次要结局

  • Clinical symptoms(Change from baseline at 6 months)

研究者

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

Georgios Tsilingaridis

Assistant professor

Karolinska Institutet

研究点 (1)

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