跳至主要内容
临床试验/NCT03490422
NCT03490422已完成不适用

Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors

National University Health System, Singapore0 个研究点目标入组 53 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
主要终点
Change in radiographic apical status

研究概览

简要总结

This Trial evaluated the extent of pulp survival following pulpotomy in the permanent tooth pulp exposed by caries and identify potential risk factors for pulpal complications.

详细描述

Healthy patients ≥ 21 years old were recruited with informed consent. Inclusion criteria were symptomatic and asymptomatic periodontally sound teeth, positive response to pulp sensibility tests, pulp exposure by caries with bleeding, haemostasis achieved within 10 minutes and normal apical tissues. Under local anaesthesia and rubber dam isolation, caries was removed before pulpotomy. Pain complaint, clinical and radiographic data were collected during recalls for up to 3 years.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient factors:
  • Male and female at least 21 years of age
  • Healthy and ambulant
  • Mild diseases only and without substantive functional limitations
  • Able to return for scheduled recalls
  • Tooth factors:
  • Deep caries leading to pulp exposure
  • With or without pre-operative spontaneous and/or aggravated pain
  • Positive response to Cold and Electric Pulp Tests
  • Positive bleeding on pulp exposure
  • Haemostasis within 10 minutes
  • Intact and continuous periodontal ligament space and dental lamina dura on radiograph

排除标准

  • Patient factors:
  • Younger than 21 years of age
  • Pregnant female
  • Poorly controlled systemic diseases e.g. diabetes mellitus, hypertension
  • Tooth factors:
  • Extensive tooth structure loss requiring post and core retained restoration
  • Uncontrolled periodontal disease
  • Cracked tooth
  • Traumatized tooth
  • Haemostasis not achieved within 10 minutes

研究组 & 干预措施

Pulpotomy

Experimental

Pulpotomy is performed in carious-exposed pulp in mature permanent teeth

干预措施: Pulpotomy (Procedure)

结局指标

主要结局

Change in radiographic apical status

时间窗: 3 years

Change from Baseline Radiographic appearance of apical tissue at 6 months, 1 year, 2 years and 3 years

次要结局

未报告次要终点

研究者

发起方
National University Health System, Singapore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Victoria Yu

Associate Professor

National University Health System, Singapore

相似试验