Tooth Discoloration Induced by Different Calcium Silicate Based Materials: in Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 4
- 主要终点
- Tooth color change
研究概览
简要总结
Vital pulp therapy including pulpotomy is commonly used for managing teeth with carious pulp exposure instead of performing root canal therapy. The gold standard materials used in this procedure are the calcium silicate based materials, however recent case reports have shown tooth discoloration caused by these materials especially MTA which is of concern to the patients. The aim of this study is to compare tooth color changes and discoloration induced by 3 calcium silicate based materials used in pulpotomy over 6 months, 12 months and yearly up to 5 years.
详细描述
Pulpotomy procedure involves removal of the coronal portion of the dental pulp followed by placement of a compatible material and subsequent coronal restoration of the tooth. Mineral trioxide aggregate is the gold standard material used in pulpotomy; however it has been implicated in tooth discoloration due to it radioopacifier. newer calcium silicate based materials including Biodentine and bioceramic have different opacifier and claimed not to cause tooth discoloration in laboratory studies.
In this clinical study tooth color measurement of teeth treated by pulpotomy using these 3 materials will be taken using vita easy shade device immediately after placement of the materials, 6 months and 12 months after the treatment then yearly up to 5 years. The discoloration potential of these 3 materials will be compared. Factors that may influence tooth discoloration will be also measured and analyzed including buccal wall thickness and time of bleeding control after pulpotomy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant will not be informed about the type of material. Investigator will be given the material only after the pulpotomy procedure was completed according to a random sequence number generator. Upon tooth color measurement the investigator will not be informed about the type of material
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vital tooth with carious pulp exposure to be treated by full pulpotomy
- •Fully erupted upper or lower molar tooth with fully formed apex
- •Tooth should have intact buccal wall (no caries or restoration)
- •Tooth should be restorable by direct composite restoration
排除标准
- •Partially erupted tooth
- •Tooth has caries on the buccal surface
- •Tooth has restoration on buccal surface
- •Tooth has preoperative coronal staining compared to adjacent teeth
结局指标
主要结局
Tooth color change
时间窗: Immediate, 6 months, 1 year and yearly up to 5 years
Darkening in tooth color shade after placement of the calcium silicate based material
次要结局
未报告次要终点
研究者
Nessrin Taha
Professor
Jordan University of Science and Technology