Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
研究概览
简要总结
The objective of this randomized double-blind study was to evaluate the effect of betamethasone in the control of postoperative pain in patients undergoing endodontic treatment.
详细描述
To prevent post endodontic treatment pain, systemic administration of corticosteroids may have their effect maximized if the infiltration is performed in the oral mucosa, near the periapex of the tooth, which concentrates the inflammatory process. The administration of corticosteroids at this moment, taking advantage of the anesthetic effect still present, ensures continuous comfort during the postoperative period.
The objective of this randomized double-blind clinical trial was to evaluate the effect of the systemic administration of betamethasone - through infiltration in the oral mucosa - to control pain and edemas in patients undergoing emergency endodontic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 72 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals had to have a tooth with pain of endodontic origin justifying emergency care;
- •Individuals diagnosed with irreversible pulpitis or necrosis associated to pericementitis.
排除标准
- •Individuals who presented:
- •Pregnancy or lactation;
- •Use of corticosteroids;
- •History of hypersensitivity to the drugs used in this study;
- •Pain associated with abscesses of endodontic origin;
- •Individuals with tuberculosis;
- •Individuals with systemic fungal infections;
- •Individuals with simple ocular herpes;
- •Individuals with glaucoma;
- •Individuals with acute psychosis.
- •Individuals with psychotic tendencies.
研究组 & 干预措施
Group betamethasone
Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg
干预措施: Bethametasone (Drug)
Group placebo
sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg
干预措施: Placebo (Drug)
结局指标
主要结局
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
时间窗: 48 hours after treatment
During the post-surgical interval of 48 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
次要结局
- Analgesic consumption(48 hours after treatment)