Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions: A 4- Year Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 73
- 主要终点
- Evaluating of clinical success of restorations
研究概览
简要总结
Aim of this clinical study is to compare the clinical success of two lining materials regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.
A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms
详细描述
Aim of this clinical study is to compare the clinical outcomes of mineral trioxide aggregate (MTA) cavity lining with calcium hydroxide (Ca(OH)2) regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.
Materials and Methods
A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms. The data will be analyzed with Pearson chi-square, Fisher exact and logrank statistics tests (p < 0.05). The Kaplan-Meier survival analysis will be conducted to reveal the survival rate.
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)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary deep caries lesion with risk of pulp exposure (radiograph depth reaching 3/4 of the dentin).
- •Restorable by direct restoration and functional permanent posterior teeth,
- •Positive response to electric pulp testing and negative response to thermal testing.
排除标准
- •Two or more cuspal loss
- •Caries beneath the gingival margin
- •Spontaneous pain history
- •Presence of any periapical pathology
- •Immature teeth with open apex
- •Pathologic mobility
研究组 & 干预措施
Dycal
calcium hydroxide cement
干预措施: Dycal (Device)
MTA
mineral trioxide aggregate
干预措施: MTA (Device)
结局指标
主要结局
Evaluating of clinical success of restorations
时间窗: 6 months
The treatment consequence was judged as "clinically successful" when the following criteria were met: positive response to electric pulp testing, negative response to cold stimuli by air-water shrinkage, no general pain, normal response to tactile tests or triggered pain not lingering, no evidence of abscess, sinus tract and no abnormal tooth mobility. These teeth were considered to be "clinically healthy" and the treatment was successful.
次要结局
未报告次要终点
研究者
Uzay Koc
Principal Investigator
Hacettepe University