Efficacy of Endodontic Treatment Using CTZ Paste in Primary Teeth: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Clinical and radiographical efficacy of the endodontic treatment
研究概览
简要总结
The aim of this study is to evaluate the efficacy of CTZ Paste in primary teeth, compared to endodontic treatment with Guedes-Pinto Paste. This is a multicenter, randomized, double-blind (patient), controlled and non-inferiority clinical study on 174 primary molars and 174 primary incisors of 3-6 years-old children with carious lesions with pulp involvement. The sample unit will be the tooth, which will be randomized into two groups. The teeth allocated to the experimental group will be treated with CTZ Paste, whereas the treatment of those teeth allocated to the control group will employ the Guedes-Pinto Paste. The procedures performed will be evaluated clinically and radiographically at 6 and 12 months. Secondary outcomes such as cost, discomfort, satisfaction and quality of life will also be evaluated.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children aged from 3 to 6 years and 11 months;
- •children present at least one upper or lower molar or primary upper incisor with untreated carious lesion with pulp envelopment;
- •children assent to participate in the study through collaborative behavior;
- •children's parents/guardians consent to their participation by signing the Informed Consent Form (ICF).
排除标准
- •tooth with carious lesion involving three or more dental surfaces, making the restoration extremely difficult or impossible;
- •tooth with internal or external resorption in more than 1/3 of the root length;
- •tooth whose crypt of the successor permanent is affected;
- •tooth which have less than 2/3 of the root;
- •patients who present health problems with oral impairment.
结局指标
主要结局
Clinical and radiographical efficacy of the endodontic treatment
时间窗: 12 Months
The tooth will be evaluated according to the presence of mobility (yes or no) and regarding radiolucency area on initial and final radiography (measured and compared with the program ImageJ).
次要结局
- Parents/Guardians' satisfaction with children's treatment(Through study completion (12 months))
- Impact of treatment on children's quality of life(Baseline and 12 months)
- Children's satisfaction with treatment(Through study completion (12 months))
- Cost-efficacy(Through study completion (12 months))
研究者
Jose Carlos P Imparato
Principal Investigator, Clinical Professor
Faculty Sao Leopoldo Mandic Campinas