Evaluate the Effectiveness of Buffering Local Anesthetic With Sodium Bicarbonate in Infected and Inflamed Teeth in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain level during tooth extraction in inflamed sites (self-reported)
研究概览
简要总结
This randomized, double-blinded, split-mouth clinical trial evaluates the effect of buffering local anesthetic with sodium bicarbonate in pediatric dental extractions. Twenty children aged 6 to 10 years with two infected primary molars on opposite sides of the maxilla participated. Each child received standard anesthetic on one side and buffered anesthetic on the other. Pain levels and onset time were measured to assess anesthetic efficacy.
详细描述
This randomized, controlled, double-blinded, split-mouth clinical trial aims to evaluate the efficacy of buffering local anesthetic solution with sodium bicarbonate in the extraction of infected and inflamed primary molars in children. Infected tissues tend to have a lower PH , which can limit the effectiveness of local anesthetics by reducing the proportion of the active, non-ionized drug form. buffering with sodium bicarbonate improve anesthetic performance by raising the pH of the solution, enhancing its diffusion and clinical effectiveness.
The study included 20 healthy children aged 6 to 10 years, each with two infected or inflamed primary molars located on opposite sides of the maxilla. A split-mouth design was employed, where each child received a standard local anesthetic solution - lidocaine 2% with epinephrine 1:80,000 - on one side, and a buffered solution (alkalinized with sodium bicarbonate) on the contralateral side.
To assess anesthetic efficacy, three parameters were measured: pulse rate (as a physiologic indicator of pain), the Sound-Eye-Motor (SEM) scale (for behavioral response), and the Wong-Baker Faces Pain Rating Scale (for subjective pain reporting). Onset time of anesthesia was also recorded.
The study aims to determine whether buffering lidocaine with sodium bicarbonate improves pain control and onset time during pediatric dental extractions in inflamed and infected tissues.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 10 years with bilateral maxillary first or second primary molars indicated for extraction due to infection and inflammation.
- •Presence of clinical signs of inflammation (e.g., redness, swelling) in the gingiva surrounding the affected teeth.
- •Medically healthy children with no systemic diseases or cognitive disabilities.
- •Children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale.
- •No intake of medications that may interfere with pain perception during the 24 hours preceding the treatment session.
排除标准
- •Presence of systemic medical conditions.
- •Children with negative or definitely negative behavior according to the Frankl Behavior Rating Scale.
- •Known allergy to the local anesthetic agent.
结局指标
主要结局
Pain level during tooth extraction in inflamed sites (self-reported)
时间窗: During the tooth extraction procedure
Procedural pain during extraction was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain. This scale uses six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to indicate the face that best matched their pain level during tooth extraction in inflamed areas. Higher scores indicate greater pain intensity.
Pain-related behavioral response during extraction in inflamed primary molars (observer-rated)
时间窗: During the tooth extraction procedure
Procedural pain behavior will be assessed using the Sound-Eye-Motor (SEM) scale. Trained observers will score behavioral responses during extraction; higher scores indicate stronger pain-related behavior.
Physiological response during extraction in inflamed primary molars (heart rate)
时间窗: through the extraction procedure
Heart rate (beats per minute) will be continuously monitored with a pulse oximeter. Increases from baseline are considered indicators of pain/stress during extraction.
次要结局
- Pain perception during injection of anesthetic solution (self-reported)(During and within 1 minute after anesthetic injection)
- Behavioral response during anesthetic injection (SEM)(During and within 1 minute after anesthetic injection)
- Physiological response to injection (heart rate)(During anesthetic injection)