Effect of topical cooling of the injection site and cold anesthetic administration on onset, anesthetic efficacy and injection pain during infiltration anesthesia of maxillary premolars with symptomatic irreversible pulpitis: A randomized controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluate the onset, anesthetic efficacy and injection pain during administration of cold local anesthesia.
研究概览
简要总结
Case history shall be recorded and clinical and radiographic examination will be performed to confirm symptomatic irreversible pulpitis . Vitality of tooth will be confirmed by EPT. Patients will be randomly allocated to two groups:
Group 1: Control
Group 2: Experimental
In group 1, 2% lignocaine anesthetic gel will be applied and after 1min, local anesthesia at room temperature will be administered via buccal infiltration.
In group 2, precooling of the injection site shall be done with ice stick for 10 sec followed by 1.8ml of cold local anesthesia (6-10℃) administration.
Patients would be directed to rate the pain following administration of local anesthesia using HP-VAS which would be recorded as pain on injection. EPT will be applied every 1min, until a negative response is obtained. This duration will be taken as the time of onset.
Endodontic treatment will be initiated . Patients would be directed to rate any pain during access preparation, pulp extirpation and instrumentation. Anesthesia shall be considered to be successful if there is no pain or only mild pain during endodontic procedure according to HP-VAS scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •.Patients with good health in the age group of 20-40 years.
- •2.Patients with symptomatic irreversible pulpitis of maxillary premolars.
- •3.Patients with preoperative pain score greater than 54mm as measured on HP-VAS scale.
排除标准
- •Individuals with systemic and mental illness.
- •Individuals with known allergy or contraindication to lignocaine.
- •Pregnant and lactating mothers.
- •Individuals who have taken analgesics 12hrs before endodontic procedure.
- •Individuals under barbiturates and benzodiazepine medication.
- •Presence of chronic endodontic lesions in relation to the tooth.
结局指标
主要结局
Evaluate the onset, anesthetic efficacy and injection pain during administration of cold local anesthesia.
时间窗: Evaluate the onset, anesthetic efficacy and injection pain during administration of cold local anesthesia at the baseline.
次要结局
- Intergroup comparison of the effects of the anesthesia.(Compare the effect of anesthesia in males & females at the baseline.)
研究者
ANJITHA T
Coorg institute of dental sciences