Color Dental Alteration Caused by Endodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Color change
研究概览
简要总结
The color change of endodontically treated teeth is a common concern in clinical practice. The objective of this study will be to evaluate, in vivo, the color change (ΔE00) caused by endodontic treatment. A randomized clinical trial (RCT) will be conducted with the objective of evaluating ΔE00 originated from epoxy resin (AH Plus) and mineral trioxide aggregate (MTA Fillapex) endodontic sealers, sectioned at the cervical level and 2 mm below, in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
详细描述
The sample syze determined that 48 anterior teeth (incisors and canines) and posterior teeth (premolars) should be included in the study. The sealer and cut will be randomly determined at time of endodontic treatment, originating four groups (n = 12): AH Plus-Cervical, MTA Fillapex-Cervical, AH Plus-2mm and MTA-2mm. The endodontic access cavities will be sealed with resin composed of the color of the dental element. The mean, standard deviation and confidence interval (CI 95%) of the values of ΔE00 obtained for each sealer will be initially analyzed using the variable cut level (cervical or 2mm) using the T test. Indeed, the values of ΔE00 will be analyzed by two-way analysis of variance, where the level of the cut and the type of sealer will be the factors under study.
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 (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
- 是
入选标准
- •endodontically treated tooth, without intraradicular retainer and fixation;
- •presence of homologous tooth to that treated, with pulp vitality and at least 1/3 of the crown;
- •correctly patient's file showing the endodontic treatment day, the endodontic filler used, the pulp condition at the first consultation, and periapical radiography, obtained with the use of a radiographic positioner, preserved and with a clear apical image
排除标准
- •dental elements submitted to retreatment;
- •files with insufficient data, and absence of quality periapical radiography
研究组 & 干预措施
AH Plus-Cervical
The objective is evaluate the color change (ΔE00) originated from epoxy resin (AH Plus) endodontic sealer, sectioned at the cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.
干预措施: endodontic treatment (Procedure)
MTA Fillapex-Cervical
The objective is evaluate the color change (ΔE00) originated from mineral trioxide aggregate (MTA Fillapex) endodontic sealer, sectioned at the cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.
干预措施: endodontic treatment (Procedure)
AH Plus-2mm
The objective is evaluate the color change (ΔE00) originated from epoxy resin (AH Plus) endodontic sealer, sectioned 2 mm below cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.
干预措施: endodontic treatment (Procedure)
MTA Fillapex-2mm
The objective is evaluate the color change (ΔE00) originated from mineral trioxide aggregate (MTA Fillapex) endodontic sealer, sectioned 2 mm below cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.
干预措施: endodontic treatment (Procedure)
结局指标
主要结局
Color change
时间窗: After immediate endodontic treatment versus after 3, 6 and 12 months
Color alteration will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically. Data will be analyzed according to sealer, cut and time
次要结局
未报告次要终点
研究者
Noéli Boscato, PhD
Professor
Federal University of Pelotas