Effect of Alcohol Consumption on the Success Rates of Local Anesthesia in Patients With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Anesthetic success
研究概览
简要总结
This prospective, randomized, double-blind clinical trial will be carried out Conservative Dentistry, Faculty of Dentistry, Jamia Millia Islamia. Seventy adult patients (35 alcoholic and 35 non-alcoholics) with symptomatic irreversible pulpits in a mandibular first or second molar will receive an IANB with 2% lidocaine. In case of pain during treatment, the procedure will be stopped, and the patients will be asked to rate the pain on the Heft-Parker scale. The injection shall be considered as successful if the patient reports pain scores less than 55 on the HP scale.
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
- •Symptomatic carious exposed mandibular first or second molars.
- •Alcoholic patients: Patient with low-moderate drinking levels according to the US National Institute on Alcohol Abuse and Alcoholism
- •Control patients: No history of alcohol consumption
- •Positive and prolonged response to thermal sensitivity tests and electric pulp test.
- •Vital coronal pulp on access cavity preparation.
- •American Society of Anesthesiologists class I or II medical history.
- •Ability to understand the use of pain scales.
排除标准
- •Active pain in more than 1 teeth
- •Teeth with fused roots.
- •Radiographic evidence of an extra root.
- •Large restorations with overhanging margins.
- •Full crowns or deep periodontal pockets.
- •Hypertension or cardiovascular diseases, compromised immunity, active infection or inflammation
- •Known allergy or contraindications to any content of the local anesthetic solution or non-steroidal anti-inflammatory drugs (NSAIDs)
- •History of known or suspected drug abuse.
- •Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids. 23
- •Pregnant or breastfeeding patients.
- •Patients with asthma, gastric ulcers, bleeding disorders.
研究组 & 干预措施
Alcoholic patients
Patients will receive an inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach.
干预措施: Lidocaine Hydrochloride (Drug)
Control patients
Patients will receive an inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach.
干预措施: Lidocaine Hydrochloride (Drug)
结局指标
主要结局
Anesthetic success
时间窗: 15 minutes following the injection
The injection shall be considered as successful if the patient reports pain scores less than 55 on the visual analouge scale. The scale is 170mm long, with 0 marked as no pain and 170 marked as the maximum pain.
次要结局
未报告次要终点
研究者
Dr. Vivek Aggarwal
Professor
Jamia Millia Islamia