The Effect of Dexamethasone in Full Pulpotomy on Postoperative Pain in Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of cryotherapy and dexamethasone on the intensity of postoperative pain in full pulpotomy procedures in permanent molars with symptomatic irreversible pulpitis. The main questions it aims to answer are:
- Does controlled irrigation with cold saline during full pulpotomy reduce the severity of postoperative pain?
- Does controlled irrigation with dexamethasone during full pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone groups, the pulp chamber was irrigated with 2°C saline solution during the final irrigation step.
In the dexamethasone group, unlike the control and cryotherapy groups, the pulp chamber was irrigated with 2 mL dexamethasone solution during the final irrigation step.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vital permanent molars exhibiting positive responses to both the cold test and the electric pulp test, with a prolonged cold response (>30 seconds) consistent with symptomatic irreversible pulpitis.
- •Presence of deep carious lesions in the included teeth (indicated for vital pulp therapy).
- •No radiographic evidence of periapical pathology (i.e., no periapical radiolucency, root resorption, or pathological widening of the periodontal ligament space).
- •Patients who had not taken analgesics or antibiotics during the 24 hours preceding the procedure.
排除标准
- •Devital permanent molars that responded negatively to cold tests and electric pulp tests
- •Permanent molars with poor periodontal status (pocket depth > 4 mm),
- •Teeth that exhibited periapical radiolucency, pathological mobility, or were deemed non-restorable
- •Systemic diseases, pregnancy or lactation, known allergies to dexamethasone or NSAIDs, recent use of analgesics (within 24 hours), and any contraindications for pulpotomy or local anesthesia
研究组 & 干预措施
Cryotherapy Group
5 mL of sterile saline solution pre-cooled to 2.5°C was administered into the pulp chamber using the same technique. This solution was also left in contact with the pulp tissue for 5 minutes, without aspiration, to provide localized cold exposure. The cold saline was stored in a calibrated medical cooler and monitored with a digital thermometer to ensure consistent temperature throughout the clinical procedure.
干预措施: Cryotherapy (Other)
Dexamethasone Group
The pulp chamber was irrigated with 2 mL of a dexamethasone sodium phosphate solution at a concentration of 4 mg/mL (Decort®, DEVA Holding, Türkiye). The solution was slowly delivered into the pulp chamber using a sterile syringe with a blunt-tipped needle and left in place for 1 minute to allow direct contact with the exposed radicular pulp tissue. Subsequently, the chamber was gently dried with sterile cotton pellets.
干预措施: Dexametasone (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: up to 72 hours
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
次要结局
未报告次要终点
研究者
Kübra Gürler
Principal Investigator
Cukurova University