Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment of Teeth With Necrotic Pulp and Apical Periodontitis After a Two-year Control Period. A Randomised Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 主要终点
- Pain intensity measure with general pain scale
研究概览
简要总结
Aim to compare Incidence of flare-ups and apical healing after single-visit or two-visits treatment of teeth with necrotic pulp and apical periodontitis after a two-year control period.
110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.
详细描述
110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex. Working length was established with EAL and confirmed radiographically. M4 system with Flex-R files were used to complete canal preparation. Level of discomfort were recorded and cases with severe postoperative pain and/or swelling were classified as flare-ups.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a) Radiographic evidence of apical periodontitis (minimum size ≥2.0 mm x 2.0 mm) and a diagnosis of pulpal necrosis confirmed by negative response to hot and cold tests and b) Need for retreatment. Thermal pulp testing was performed by the author, and radiographic interpretation was verified by one certified oral surgeon.
排除标准
- •patients without inclusion requirements or failure to obtain patient´s authorization. Patients, were excluded if they were younger than 18 years old, pregnant, had a positive history of antibiotic use within the past month, suffered from diabetes, or other systemic diseases. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.
研究组 & 干预措施
Post operative Pain after a RCT
Ibuprofen for Post operative pain. Take 400 mg taken a week after. Incidence of flare ups after a single vs multiple visits root canal treatments.
干预措施: Ibuprofen for post operative pain (Procedure)
Post operative Pain after a RCT
Ibuprofen for Post operative pain. Take 400 mg taken a week after. Incidence of flare ups after a single vs multiple visits root canal treatments.
干预措施: Acetaminophen 325 mg for Flare up (Drug)
Flare up
Acetaminophen 325 mg for Flare Up. Taken second day after. Incidence of Post operative pain after root canal treatment in one vs two visits.
干预措施: Ibuprofen for post operative pain (Procedure)
Flare up
Acetaminophen 325 mg for Flare Up. Taken second day after. Incidence of Post operative pain after root canal treatment in one vs two visits.
干预措施: Acetaminophen 325 mg for Flare up (Drug)
结局指标
主要结局
Pain intensity measure with general pain scale
时间窗: a week
Each patient will recall a week to evaluate post operative pain
次要结局
未报告次要终点
研究者
Jorge Paredes Vieyra
DDS, MsC, PhD
Universidad Autonoma de Baja California