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临床试验/NCT03488316
NCT03488316Unknown不适用

Influence of Temporary Filling Material Composition on the Success Rate of Endodontic Treatments - Randomized Clinical Study

PAULO VINICIUS SOARES1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月1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
发起方
入组人数
20
试验地点
1
主要终点
Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

研究概览

简要总结

The aim of this study is through a randomized clinical trial, double blind, splitmouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

详细描述

The need for endodontic treatment is still very common in the clinical routine, whether due to dento-alveolar trauma or caries. In some cases, the temporary filling procedure is required until the endodontic treatment is completed. The temporary filling material should be biocompatible and bacteriostatic. The aim of this study is through a randomized clinical trial, double blind, split-mouth, evaluate the success rate (contamination rate, periapical lesion relapse and the presence of exudate between the treatment's sessions) of endodontically treated teeth that required filling with temporary material. The composition of the temporary filling material (cement (Based on calcium hydroxide; and based on mineral trioxide aggregate) will be evaluated. Twenty participants with at least two teeth with the need of endodontic treatment will be selected. The teeth will be randomly divided into 2 different groups according to the temporary filling material composition (Based on calcium hydroxide; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Healthy volunteers
  • Both genres
  • Presence of at least two teeth with indication of endodontic treatment
  • Good oral hygiene

排除标准

  • Dentures or orthodontics
  • Presence of periodontal disease
  • Presence of parafunctional habits
  • Presence of systemic disease
  • Presence of severe psychological disturbe;
  • Constant use of analgesic and, or anti-inflammatory
  • Allergic response to dental products

研究组 & 干预措施

MTA temporary filling material

Active Comparator

Temporary filling with MTA

干预措施: Definiteve canal root obturation (Procedure)

MTA temporary filling material

Active Comparator

Temporary filling with MTA

干预措施: Definitve restoration (Procedure)

MTA temporary filling material

Active Comparator

Temporary filling with MTA

干预措施: Material insertion on the root canal (Procedure)

MTA temporary filling material

Active Comparator

Temporary filling with MTA

干预措施: Material re-insertion on the root canal accordging to the infection needs. (Procedure)

MTA temporary filling material

Active Comparator

Temporary filling with MTA

干预措施: Absolute isolation (Procedure)

MTA temporary filling material

Active Comparator

Temporary filling with MTA

干预措施: Manipulation of the temporary filling material based on Mineral trioxide aggregate (Drug)

Calcium Hydroxide temporary filling material

Active Comparator

Temporary filling with Ca(OH)2

干预措施: Carie removal (Procedure)

Calcium Hydroxide temporary filling material

Active Comparator

Temporary filling with Ca(OH)2

干预措施: Absolute isolation (Procedure)

Calcium Hydroxide temporary filling material

Active Comparator

Temporary filling with Ca(OH)2

干预措施: Manipulation of the temporary filling material based on Calcium Hydroxide (Drug)

Calcium Hydroxide temporary filling material

Active Comparator

Temporary filling with Ca(OH)2

干预措施: Material insertion on the root canal (Procedure)

Calcium Hydroxide temporary filling material

Active Comparator

Temporary filling with Ca(OH)2

干预措施: Material re-insertion on the root canal accordging to the infection needs. (Procedure)

Calcium Hydroxide temporary filling material

Active Comparator

Temporary filling with Ca(OH)2

干预措施: Definiteve canal root obturation (Procedure)

Calcium Hydroxide temporary filling material

Active Comparator

Temporary filling with Ca(OH)2

干预措施: Definitve restoration (Procedure)

MTA temporary filling material

Active Comparator

Temporary filling with MTA

干预措施: Carie removal (Procedure)

结局指标

主要结局

Contamination rate of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

时间窗: 1 year

Periapical lesion relapse of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

时间窗: 1 year

Presence of exudate between the treatment's sessions of endodontically treated teeth that required filling with temporary material with a 1 year follow up.

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
PAULO VINICIUS SOARES
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

PAULO VINICIUS SOARES

Director of NCCL Research Group

Federal University of Uberlandia

研究点 (1)

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