Comparative evaluation of pain perception during two percent lignocaine administration and extraction of primary mandibular molars by infiltration, intraligamentary and inferior alveolar nerve block technique in primary and mixed dentition children aged three to nine years A double blinded randomized controlled clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain perception during two percent lignocaine administration and extraction procedure is to be determined by infiltration, intraligamentary and inferior alveolar nerve block technique.Evaluation will take through using SEM scale.
研究概览
简要总结
This study will be conducted in department of pediatric and preventive dentistry. Study will be conducted in children of age group 3 tp 9 years. Total 90 primary mandibular molars fulfilling inclusion and exclusion criteria will be selected for study. Pain during injection will be evaluated by investigator with sound eye motor scale. After injection, extraction procedure will take place and investigator will evaluate the pain perception using sound eye motor scale. Children will be divided into three groups. Group A Infiltration using 2 % lignocaine will be administered and then extraction will be carried out. Group B intaligamentary using 2% lignocaine will be administered and extraction will be carried out. Group C Inferior alveolar nerve block will be administered and extraction will be carried out. Statistical analysis by SPPS version 21. Overall intergroup and intragroup comparision by Anova F test. Randomization by simple randomization by using lottery method. Allocation concealment by SNOSE method . Blinding will be double blinding
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 3.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Frankle behaviour rating scale class 3 or class 4 i.e co-operative behaviour for dental treatment under local anesthesia
- •Children of age group 3years to 9 years
- •No history of allergic reactions to local anesthesia 4.Mandibular teeth indicated for extraction procedure under local anesthesia 5.Not taking any medication that potentially interfere with pain assessment within 24 hours before the treatment
- •No difficulties in communication 7.Mandibular primary molars which have half radicular physiological resorptions and minimum half completed root development of the permanent teeth germs determined by periapical radiography.
排除标准
- •No informed consent from parents or patient
- •Patients with allergies to local anesthetics 3.History of significant medical conditions contraindicating use of local anesthesia containing epinephrine
- •Frankle behavior rating scale 1 and 2 5.
结局指标
主要结局
Pain perception during two percent lignocaine administration and extraction procedure is to be determined by infiltration, intraligamentary and inferior alveolar nerve block technique.Evaluation will take through using SEM scale.
时间窗: 9 weeks
次要结局
未报告次要终点