Comparison of Computer-Controlled and Conventional Local Anesthesia Techniques on Dental Anxiety and Pain During Mandibular Primary Molar Pulpectomy: A Split-Mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Dental Anxiety
研究概览
简要总结
This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care.
Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements.
The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.
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
- Single (Outcomes Assessor)
盲法说明
The behavioral pain assessment (FLACC score) will be performed by an independent outcome assessor who is blinded to the local anesthesia technique used. Due to the nature of the interventions, participants and treating clinicians cannot be blinded.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 8 years.
- •Requiring bilateral pulpectomy treatment of mandibular primary molars.
- •Frankl Behavior Rating Scale score of 3 or
- •American Society of Anesthesiologists (ASA) Physical Status I.
- •No known allergy to local anesthetic agents.
- •No previous experience with dental local anesthesia.
- •No signs of acute abscess or swelling in the treatment area.
- •Parent or legal guardian able to provide written informed consent and child willing to participate.
排除标准
- •ASA Physical Status II or higher.
- •Known allergy or contraindication to local anesthetic agents.
- •Frankl Behavior Rating Scale score of 1 or
- •Children receiving psychological or psychiatric treatment.
- •Physical or intellectual disabilities that could interfere with study procedures.
- •Previous experience with dental local anesthesia.
- •Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.
研究组 & 干预措施
Conventional Inferior Alveolar Nerve Block
干预措施: Conventional Inferior Alveolar Nerve Block (Procedure)
Conventional Inferior Alveolar Nerve Block
干预措施: Articaine hydrochloride with epinephrine 1:100,000 (Drug)
Conventional Inferior Alveolar Nerve Block
干预措施: Standard Dental Aspirating Syringe (Device)
Computer-Controlled Local Anesthesia
干预措施: Computer-Controlled Local Anesthesia (Procedure)
Computer-Controlled Local Anesthesia
干预措施: Articaine hydrochloride with epinephrine 1:100,000 (Drug)
Computer-Controlled Local Anesthesia
干预措施: Computer-Controlled Local Anesthetic Delivery System (Device)
结局指标
主要结局
Dental Anxiety
时间窗: Baseline and immediately after treatment
Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.
Behavioral Pain During Local Anesthesia
时间窗: Immediately after local anesthetic injection
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain.
次要结局
- Self-reported Pain(Immediately after local anesthetic injection)
- Facial Image Scale (FIS) Score(Baseline and immediately after treatment.)
- Heart Rate(Baseline and during local anesthetic administration)
- Blood Pressure(Baseline, during local anesthetic administration, and immediately after treatment)
- Peripheral Oxygen Saturation (SpO₂)(Baseline, during local anesthetic administration, and immediately after treatment)
- Body Temperature(Baseline, during local anesthetic administration, and immediately after treatment)
研究者
DİLARA NİL GÜNAÇAR
Associate Professor
Recep Tayyip Erdogan University Training and Research Hospital