Conventional Versus Computer-Assisted Dental Anesthesia: A Pilot Study of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Pain perception during local anesthetic administration
研究概览
简要总结
The purpose of this clinical trial was to compare two methods of delivering local dental anesthesia in undergraduate dental students: a computer-controlled local anesthetic delivery (CCLAD) system and a conventional dental syringe. The study evaluated whether the computer-controlled system reduced pain during the administration of local anesthesia compared with the conventional technique.
The main questions this study aimed to answer were:
Does a computer-controlled local anesthetic delivery system reduce pain during maxillary buccal infiltration compared with a conventional dental syringe? Are there differences in physiological responses (blood pressure, heart rate, and oxygen saturation) between the two anesthetic delivery methods? Which anesthetic delivery method do participants prefer after experiencing both techniques? Would participants recommend their preferred anesthetic delivery method to others? Participants attended two study visits approximately one week apart. Each participant received local anesthesia using both delivery methods in a randomized order, serving as his or her own control. Pain, dental anxiety, physiological parameters, anesthetic delivery preferences, and willingness to recommend the preferred method were assessed during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator responsible for assessing participant-reported outcomes (pain perception, preferred anesthetic delivery method, and willingness to recommend the preferred method) remained blinded to treatment allocation throughout the study. Participants and the care provider administering the interventions were not blinded because of the nature of the interventions. The investigator recording physiological measurements became aware of the allocated intervention during anesthetic administration because the delivery device was visible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergraduate dental student enrolled in the Local Anesthesia course at the Montemorelos University School of Dentistry.
- •Aged 18 years or older.
- •Able and willing to provide written informed consent.
- •Willing to attend both study periods.
排除标准
- •Pregnancy or lactation.
- •Known allergy or contraindication to lidocaine or epinephrine.
- •Systemic conditions contraindicating elective dental treatment.
- •Use of medications that could alter cardiovascular responses.
- •Medical condition that could interfere with pain perception or study participation.
结局指标
主要结局
Pain perception during local anesthetic administration
时间窗: Immediately after each anesthetic administration
Pain perceived during maxillary buccal infiltration anesthesia administered with a computer-controlled local anesthetic delivery system or a conventional aspirating dental syringe. Pain was assessed immediately after each intervention using a 10-cm Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 indicated "worst imaginable pain".
次要结局
- Dental anxiety(Baseline (before the first study intervention))
- Systolic and diastolic blood pressure(Before, during, and immediately after each anesthetic administration)
- Heart rate(Before, during, and immediately after anesthetic administration)
- Peripheral oxygen saturation (SpO₂)(Before, during, and immediately after anesthetic administration)
- Participant-reported preferred anesthetic delivery method(Immediately after completion of the second study intervention)
- Willingness to recommend the preferred anesthetic delivery method(Immediately after completion of the second study intervention)
研究者
Jose Leonardo Jimenez-Ortiz
Faculty Member, Montemorelos University School of Dentistry
University of Montemorelos