Evaluation of the Effects of Different Local Anesthesia Techniques on Dental Anxiety and Pain During Vital Pulp Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Pain Response During Local Anesthesia Administration
研究概览
简要总结
This prospective observational study aims to evaluate the effects of different local anesthesia techniques on dental anxiety and pain in children undergoing vital pulp therapy of permanent mandibular first molars. Conventional inferior alveolar nerve block and two computer-controlled local anesthetic delivery (CCLAD) systems used in routine clinical practice will be compared. The choice of anesthesia technique will be based on the clinician's routine decision-making, and no additional intervention or modification of standard treatment will be performed for research purposes. Dental anxiety, pain, physiological parameters, and postoperative complications will be assessed using validated clinical scales and routine clinical measurements. The findings may help improve pain and anxiety management during pediatric dental treatment while supporting evidence-based selection of local anesthesia techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 8-10 years.
- •Children and parents/legal guardians who agree to participate in the study and provide informed consent.
- •Patients requiring vital pulp therapy of a permanent mandibular first molar.
- •Patients classified as Frankl Behavior Rating Scale score 3 or
- •Systemically healthy children (ASA I).
- •Children with adequate cognitive and communication abilities to understand the study procedures and pain/anxiety assessment scales.
- •Permanent mandibular first molars without clinical or radiographic signs of abscess, fistula, or periapical pathology.
排除标准
- •Children with systemic diseases or medical conditions affecting dental treatment.
- •Children classified as Frankl Behavior Rating Scale score 1 or
- •Patients with known allergy or hypersensitivity to local anesthetic agents (e.g., lidocaine, articaine).
- •Teeth with acute dental infection signs, including abscess, cellulitis, or extensive infection.
- •Teeth showing clinical or radiographic evidence of periapical pathology.
- •Children unable to understand or complete pain and anxiety assessment scales due to cognitive, visual, hearing, or communication limitations.
- •Patients who do not comply with the study procedures or withdraw consent.
研究组 & 干预措施
Conventional Inferior Alveolar Nerve Block
Participants in this cohort receive conventional inferior alveolar nerve block anesthesia as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the anesthesia procedure is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
QuickSleeper Computer-Controlled Local Anesthesia
Participants in this cohort receive computer-controlled local anesthetic delivery using the QuickSleeper system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the routine treatment protocol is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
Controlled Local Anesthetic Delivery System Group
Participants in this cohort receive computer-controlled local anesthetic delivery using the SOAN system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The SOAN system allows controlled administration of local anesthetic solution with regulated flow and pressure during the injection procedure. The anesthesia technique is selected by the treating clinician according to standard clinical practice and clinical requirements. No additional intervention, modification of the routine treatment protocol, or procedure solely for research purposes is performed. Dental anxiety, pain responses, physiological parameters, and postoperative outcomes are evaluated and recorded during and after the routine dental treatment process.
结局指标
主要结局
Pain Response During Local Anesthesia Administration
时间窗: During local anesthesia administration
Pain response during local anesthesia administration will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale evaluates behavioral pain responses in children based on five domains: facial expression, leg movement, activity, crying, and consolability. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
次要结局
- Dental Anxiety Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf)(Baseline (before treatment) and immediately after completion of treatment)
- Immediate Emotional Status Assessed by the Facial Image Scale (FIS)(Before anesthesia administration and after local anesthesia administration)
- Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale(Immediately after completion of treatment)
- Heart Rate(Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment)
- Postoperative Complications After Vital Pulp Therapy(24 hours after treatment)
- Blood Pressure(Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment)
- Peripheral Oxygen Saturation (SpO₂)(Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment)
- Body Temperature(Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment)
研究者
DİLARA NİL GÜNAÇAR
Assoc.Prof.
Recep Tayyip Erdogan University Training and Research Hospital