Clinical And Radiographic Efficacy Of MTA Flow In Apicoectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
The goal of this observational study is to learn about the short-term effects of MTA flow thick material in apicoectomy treatment. Participants are patients who take MTA flow to treat their apical lesion. The main question it aims to answer is:
Is MTA flow thick material effective for retrograde filling in patients who require apicoectomy for treating apical lesion? Participants already taking MTA flow as part of their regular dental care for apicoectomy will be followed-up treatment results in 6 months.
详细描述
Quality assurance plan: all patients satisfy the inclusion criteria are invinted to participate the study. Radiography was performed using an standard kit. All surgical procedures were conducted by an experienced oral surgeon. Clinical signs, radiographic signs are independently evaluated by an endodontist and oral surgeon.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification: medical records adn paper report form. Data dictionary: clinical signs, swelling, pain, fistula, radiographic signs, success rate, rarefaction, periodontal space.
Standard Operating Procedures: none. Sample size assessment: none available. Plan for missing data: exclude from the participants, missing case will be reported in the results.
Statistical analysis plan: Data were collected and analysed using JASP software, version 0.19.3 (University of Amsterdam, Amsterdam, The Netherlands). Categorical variables are presented as absolute counts and percentages, whereas numerical variables are expressed as mean values with standard errors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older
- •systemic health classified as I or II according to the American Society of Anesthesiologists (ASA) classification
- •willingness to participate in the study
- •failure of conventional or repeat endodontic treatment
- •a periapical lesion with a diameter ≥ 5 mm
排除标准
- •a crown-to-root ratio ≥ 1.0
- •inability to comply with the follow-up protocol
研究组 & 干预措施
MTA flow
MTA flow group have this material for retrograde filling in apicoectomy.
干预措施: MTA flow material (Drug)
结局指标
主要结局
Clinical success
时间窗: 6 months
Clinical success is defined as absence of 4 clinical signs. These clinical signs included pain, swelling, and fistula at the etiologic tooth.
Radiographic success
时间窗: 6 months
To evaluate healing progression on periapical radiographs, images obtained at 3 and 6 months were compared with those taken at 7 days post-surgery. Radiographic success was evaluated according to the criteria proposed by Rud et al. (1972) and Molven et al. (1987).
次要结局
未报告次要终点
研究者
Son Hoang Le
Lecturer
University of Medicine and Pharmacy at Ho Chi Minh City