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临床试验/NCT01224925
NCT01224925已完成不适用

Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal

University of Tromso4 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2010年10月18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
入组人数
80
试验地点
4
主要终点
Survival of Capped Pulps

研究概览

简要总结

This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with a carious pulpal exposure.

详细描述

Calcium hydroxide (CH) is considered the standard material for pulp capping with good results in cases with pulpal exposure as a result of dental trauma both in animal and clinical studies. However, in carious exposures, follow-up studies of direct pulp capping performed with CH based materials have shown increasing failure rates and the outcome has been considered uncertain. Direct capping of carious exposures still remains a controversial treatment for mature teeth.

A new material, mineral trioxide aggregate (MTA) was introduced for root end filling material almost two decades ago. It is also suggested for pulp capping. MTA cement has showed good sealing ability and bio-compatibility in animal studies. Results from studies in humans corroborate the results from animal studies.

Although the overall results of pulp capping in human studies using MTA are very positive, well designed and controlled clinical studies, especially involving carious exposures on adult teeth are lacking.At the time the present study was launched, there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth, thus undermining the generalizability of the results to adult patients with carious exposures.

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
Single (Participant)

盲法说明

Patient -blinded

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-55 years
  • •1st and 2nd permanent molars
  • •Proximal caries to inner 1/3 of dentin (bite-wing)
  • •Apex closed, no periapical changes (apical radiograph)
  • •No periodontal pockets deeper than 4mm
  • •Medical history non-contributory (incl.pregnancy)
  • •No medication (no antibiotics during last month)
  • •No signs or symptoms more severe than reversible pulpitis
  • •Positive response to electrical pulp test(EPT) or cold test
  • •Written consent Inclusion requires compliance with all the criteria listed

排除标准

  • •During the treatment there will be no pulpal exposure
  • •The bleeding of the exposed pulp cannot be controled in 10 minutes

研究组 & 干预措施

Capping over carious exposure with Dycal

Active Comparator

Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany)

干预措施: Direct pulp capping with Dycal (Procedure)

Capping over carious exposure with WMTA

Experimental

Total caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA)

干预措施: Direct pulp capping (Procedure)

结局指标

主要结局

Survival of Capped Pulps

时间窗: 44 month

Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study.

次要结局

  • Postoperative Pain 1 Week After Treatment.(one week)

研究者

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

Rita Kundzina

DDS,PhD (Associate professor (endodontics)

University of Tromso

研究点 (4)

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