A Comparison the Effectiveness of Anesthesia With Lidocaine 2% or Articaine 4% in Children With Molar Incisor Hypomineralisation (MIH)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- dental pain
研究概览
简要总结
Aims: Comparison of injection pain with lidocaine and articaine in children with MIH .
Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars.
Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old
详细描述
Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old Each child will receive either lidocaine or articaine at their first or second visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absolute positive or positive behavior according to the Frankel Scale.
- •Healthy, both physically and mentally.
- •Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
- •A child with a MIH-affected mandibular permanent first molar on the right and left sides .
排除标准
- •Teeth with non-response pulpitis Inflammation at the injection site.
- •Allergy to the substances used in anesthesia.
- •Presence of general or developmental medical conditions.
研究组 & 干预措施
: A (Lidocaine 2%)
20 children will be injected with 1 ml of lidocaine 2% with epinephrine. each one received lidocaine2% at his\her first or second visit.
Half of the total number of injections for 20 children i.e. 20 injections will be distributed randomly to the two drugs using the randomization table
干预措施: Lidocaine 2% (Drug)
B (Articaine 4%)
20 children will be injected with 1 ml of Articaine 4% with epinephrine. each one received articaine 4% at his\her first or second visit.
Half of the total number of injections for 20 children i.e.20 injections will be distributed randomly to the two drugs using the randomization table
干预措施: Articaine 4% (Drug)
结局指标
主要结局
dental pain
时间窗: Immediately after the treatment
self assessment pain by the children using Wong-Baker faces pain rating scale (a scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10,which represents "hurts like the worst pain imaginable" )
次要结局
未报告次要终点