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临床试验/NCT03410134
NCT03410134Unknown不适用

Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis

Hacettepe University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis

研究概览

简要总结

The purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis

详细描述

Permanent molar teeth meeting the inclusion criteria will be included into the study. Following local anaesthesia and dental dam application, caries excavation will be performed; and after exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) using a sterile high-speed round bur under water coolant. After haemostasis is achieved, Mineral trioxide aggregate (MTA) will be gently placed over the pulp to a thickness of 2-3 mm and the tooth will be restored using glass ionomer cement and composite resin. A postoperative periapical radiograph will be taken. Patients will be reviewed at 6., 12., 24. and 36. months for clinical and radiographical success. The data will be analysed statistically using chi square test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients and parents of the patients who accept to participate and sign the informed consent
  • Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms
  • Teeth which can be restorable after the treatment.
  • Teeth which has good periodontal health and in the absence of sinus tracts or swelling.

排除标准

  • Patients and parents of the patients who does not accept to participate and sign the informed consent
  • Teeth which have dentoalveolar or extraoral swelling
  • Teeth which have periodontal disease, mobility or alveolar bone loss
  • Teeth which are not restorable
  • Patients who are not cooperative with the treatment

结局指标

主要结局

Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis

时间窗: 3 years

Long-term success of vital pulp therapy in young permanent teeth with irreversible pulpitis. Evaluation criteria will be; 1. spontaneous pain (absent/present); 2. tenderness to percussion/palpation (absent/present); 3. mobility (no mobility/ 1mm/ 2mm/ 3mm mobility) 4. swelling (absent/present); 5. fistula (absent/present) 6. periapical/interradicular radiolucency (absent/present); 7. widened periodontal ligament (absent/present); 8. loss of lamina dura (absent/present); 9. internal/external root resorption (absent/present).

次要结局

未报告次要终点

研究者

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

Zafer Cavit Cehreli, DDS, PhD

Principal Investigator

Hacettepe University

研究点 (2)

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