Clinical Outcome of Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change in the status of periapical lesion size
研究概览
简要总结
The study design is a double blinded randomized controlled trial and 170 subjects (teeth) , 85 in each of the 2 groups, will be enrolled from the patients at the NUH dental centre endodontic unit. The study aims to assess how the use of TotalFill® bioceramic sealer affects the healing outcome of apical periodontitis compared to a control AH plus®.
Conventional root canal treatment will be done during this study. Radiographs will be taken at each study visit during the study for root canal. The preoperative, postoperative and review clinical and radiographic data will be analysed.
详细描述
Randomization and Blinding Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups. Allocation will be by random permuted block and stratified by gender to enhance balance. Computer generated randomized allocation for each subject will be concealed in opaque envelope. The envelope will only be opened by the operator on the obturation visit of the enrolled patient and the randomization number assigned to them.
In the event that a patient has more than 1 tooth eligible for the study, only one tooth on left and/or right side of the mouth will be recruited for the study. Therefore, a patient could contribute a maximum of two teeth for this study (i.e. a maximum of one tooth on each side of the mouth). Selection of tooth will be done using computer generated randomization number.
Study Visits and Procedures After cleaning and shaping and the patients are deemed ready for obturation, the patients will be randomly assigned to one of the 2 groups for obturation using AH plus® or TotalFill® bioceramic sealer.
- The patients and the examiners will be blinded to the type of sealer used but it would not be possible to blind the operators.
b. Post Study Follow up and Procedures
- A follow up phone call will be made to collect the patient pain experience on day 1, day 3 and day 7 post treatment which they have recorded on their pain/discomfort diary.
- At the 6-month and 12-month review, patients will be examined for any clinical signs and symptoms and a review radiograph will be taken to assess the size of the periapical lesion.
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)
盲法说明
Blinding will be done to the assessors to reduce bias to healing assessment. As well, participants won't know which treatment they are undergoing.
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A preoperative periapical radiograph will be required for diagnosis.
- •Subjects at least 21 years old.
- •Medically healthy
- •In a patient with multiple teeth requiring root canal treatment, only 1 tooth from each side will be included and selected at random.
排除标准
- •Patient below 21 years old
- •Pregnant women.
- •Patients with autoimmune diseases and uncontrolled diabetes.
- •Teeth with periodontal probing depths of 5mm or more.
- •Incomplete root formation that is detected radiographically.
- •Cracked teeth
- •Teeth are deemed to have poor restorative prognosis.
- •Teeth with adjacent teeth on the same side that require root canal treatment
结局指标
主要结局
Change in the status of periapical lesion size
时间窗: comparison of the periapical lesion size at baseline, 6 month and 12 month
Proportion z-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C\&S visits).
次要结局
- Comparison of the pain score of post-op pain(Day 1, Day 3 and Day 7 post treatment)