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临床试验/NCT02492841
NCT02492841已完成2 期

Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years

Universidad de los Andes, Chile1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
169
试验地点
1
主要终点
Parameters Evaluated After Treatment

研究概览

简要总结

Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation.

Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

详细描述

Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patients
  • Patients with at least one full or partial tooth root development
  • Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
  • Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
  • Teeth that have pulp exposure not exceeding 1 mm in size.

排除标准

  • Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
  • Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .

研究组 & 干预措施

Mineral trioxide aggregate (MTA)

Experimental

Mineral trioxide aggregate Root canal repair material

干预措施: Mineral trioxide aggregate (Drug)

Calcium hydroxide

Active Comparator

-material for pulp capping

干预措施: Calcium hydroxide (Drug)

Biodentine

Experimental

Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping

干预措施: Biodentine (Drug)

结局指标

主要结局

Parameters Evaluated After Treatment

时间窗: 3 months, 6 moths and 12 months

vitality test with electric device cold and hot test radiographic evaluation

次要结局

  • Number of Participants With Adverse Effects(1 week, 3 and 6 months)

研究者

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

Dra. Claudia Brizuel

DDS

Universidad de los Andes, Chile

研究点 (1)

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