Effect of Submucosal Cryotherapy Compared to Steroidal and Non-Steroidal Anti-Inflammatory Drugs Injection on Postoperative Endodontic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- the level of post-endodontic pain
研究概览
简要总结
The goal of this clinical trial is to compare submucosal Cryotherapy with different anti-inflammatory drugs in the reduction of post-endodontic pain in upper premolars with symptomatic irreversible pulpitis.
The main question it aims to answer is:
Is there is a difference in post-endodontic pain intensity following submucosal cryotherapy or anti-inflammatory drugs injection in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment preceded by preoperative injection of cold saline (cryotherapy) or preoperative injection of anti-inflammatory drugs Researchers will compare [Cryotherapy, Non steroidal anti-inflammatory drugs, steroids and no intervention] to see the intensity of post-endodontic pain.
详细描述
The study will be conducted on 52 maxillary premolar teeth; with 13 maxillary premolars in each group (n=13). An independent individual withholding the random allocation sequence, will preoperatively inform a second individual responsible for injection, about the solution required to be injected according to the patient number in the preformed randomized sequence. Triple blinding will be maintained in this study as the operator, the patients and the outcome assessor will not be aware of their group/used sub-mucosal injection.
Group I: (Diclofenac Sodium) submucosal infiltration injection of 1 ml diclofenac sodium (25mg/ml) after the normal local anaesthetic routine.
Group II: (Dexamethasone) Submucosal infiltration injection of 1 ml dexamethasone sodium phosphate (4mg/ml) after the normal local anaesthetic routine..
Group III: (Cryotherapy) Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C after the normal local anaesthetic routine..
Group IV: (Negative control) Patients received no injection apart from the normal local anaesthetic routine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Egyptian healthy both gender patients (Category: American Society of Anesthesiologists ASA class I)
- •Patients age (18- 50) years old.
- •Maxillary premolar teeth diagnosed with symptomatic irreversible pulpitis.
- •No clinical or radiographic evidence of periapical nor periodontal pathosis.
- •Compliant patient.
排除标准
- •The vulnerable group; prisoners, pregnant females, mentally ill, severe systemic diseases, psychological diseases, TMJ problems.
- •Analgesics or anti-inflammatory drugs taken within 24 h before the intervention.
- •Over instrumentation during treatment.
- •Long-term use of corticosteroids.
- •Access revealing necrotic tooth indicating a false positive diagnosis.
- •Sensitivity to any of the pharmaceuticals intended to be used in this study.
- •Intra operative complications such as canal calcification, or loss of apical Patency.
结局指标
主要结局
the level of post-endodontic pain
时间窗: 72 hours after completion of endodontic treatment
Evaluation of the pain intensity using the Numeric Rating Scale. The Numeric Rating Scale measures pain intensity. Numeric Rating Scale consists of scores ranged from 0-10,with lowest 0 as lowest score representing ('no pain') and 10 as highest score representing ('pain as bad as it could possibly be)
次要结局
未报告次要终点
研究者
Mai Shalabi
Teaching Assistant in the department of endodontics faculty of dentistry ASU
Ain Shams University