The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo on Postoperative Pain in Teeth With Irreversible Pulpitis and Apical Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Level of post operative pain with administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis
研究概览
简要总结
Aim. To compare the outcome of preoperative administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis.
详细描述
The institutional review board of the Faculty od Odontology Tijuana México approved the study protocol and all the participants were treated in accordance with the Helsinki Declaration (www.cirp.org/library/ethics/helsinki). The study started in February 2016 and ended in February 2017. The main inclusion criteria were: a) A diagnosis of pulpitis confirmed by positive response to hot and cold tests and b) Clinical and radiographic evidence of symptomatic apical periodontitis. It was determined based on the clinical symptoms severe preoperative pain (VAS > 60) and severe percussion pain (VAS > 60). Confirmed by positive response to hot and cold tests. Thermal pulp testing was performed by the author, and radiographic interpretation was verified by one certified oral surgeon.
Patient selection.
Fifty-four of sixty-five patients (29 women and 25 men), 18 to 60 years of age with 54 eligible teeth consented to participate in the study. The study design is shown in Figure 1. The patients were randomly divided into three groups using a web program. The patient number and group number were recorded. Informed consent was obtained from each patient and the possible discomforts and risks were fully explained.
A total of 54 patients were divided into three groups (n = 18) according to the type of preoperative drug administrated, as follows: Group A: ketorolac 10mg (Siegfried Rhein S.A. de C.V, Mexico,DF), Group B: Diclofenac Na 50mg (Voltaren, Novartis Mexico), and Group C: A placebo (capsule filled with sugar).
A registered pharmacist compounded identical-appearing capsules of the ketorolac, Diclofenac Na and the placebo (opaque yellow size ''0'' capsules). All medications were placed in identical bottles so that they were indistinguishable to the investigator.
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 (Participant)
盲法说明
Patient selection.
Fifty-four of sixty-five patients (29 women and 25 men), 18 to 60 years of age with 54 eligible teeth consented to participate in the study. The patients were randomly divided into three groups using a web program. The patient number and group number were recorded. Informed consent was obtained from each patient and the possible discomforts and risks were fully explained.
A total of 54 patients were divided into three groups (n = 18) according to the type of preoperative drug administrated, as follows: Group A: Administration of ketorolac 10mg, Group B: Administration of Diclofenac Na 50mg, and Group C: A placebo (capsule filled with sugar).
After 15 minutes each participant received the treatment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient selection was based on the following criteria:
- •The aims and requirements of the study were freely accepted;
- •Treatment was limited to patients in good health;
- •Patients with symptomatic or asymptomatic teeth with vital pulps and apical periodontitis;
- •A positive response to hot and cold pulp sensitivity tests;
- •Presence of sufficient coronal tooth structure for rubber dam isolation;
- •No prior endodontic treatment on the involved tooth and
- •No analgesics or antibiotics were used five days before the clinical procedures began.
排除标准
- •Exclusion criteria included the following:
- •Patients who did not meet inclusion requirements;
- •Patients who did not provide authorization for participation;
- •Patients who were younger than 16 years old;
- •Patients who were pregnant;
- •Patients who were diabetic;
- •Patients with a positive history of antibiotic use within the past month;
- •Patients whose tooth had been previously accessed or endodontically treated;
- •Teeth with root resorption, and
- •Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm, or the presence of a periapical radiolucency more than 2 cm diameter also were excluded of the study.
研究组 & 干预措施
ketorolac 10 mg
Administration of one dose Ketorolac 10 mg 15 minutes before treatment
干预措施: one dose ketorolac 10 mg (Drug)
Diclofenac
Administration of one dose Diclofenac 15 minutes before treatment
干预措施: One dose Diclofenac (Drug)
Placebo oral capsule
Administration of Placebo capsule 15 minutes before treatment
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Level of post operative pain with administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis
时间窗: 1 year after RCT
One dose administration before the RCT done
次要结局
- Level of Post operative pain after administration of single dose before RCT(One year after root canal treatment)
研究者
Jorge Paredes Vieyra
Principal Investigator. PhD
Universidad Autonoma de Baja California