The Effect of Dental Anxiety on the Success of Mandibular Anesthesia in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Success Rate of Mandibular Anesthesia
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of dental anxiety on the success of mandibular anesthesia in patients with symptomatic irreversible pulpitis in mandibular molar teeth.
The main questions it aims to answer are:
Does dental anxiety influence the success rate of inferior alveolar nerve block (IANB)? Is there a correlation between salivary cortisol levels and anesthesia outcomes in anxious patients?
Researchers will compare two groups of patients based on their Modified Dental Anxiety Scale (MDAS) scores:
Low/No anxiety group (MDAS < 10) Moderate to high anxiety group (MDAS ≥ 11, including those with dental phobia)
Participants will:
Rate their pre-treatment pain using the Heft-Parker Visual Analog Scale (HP-VAS) Provide salivary samples for cortisol measurement before and after anesthesia Undergo standardized mandibular anesthesia protocols (IANB and buccal-lingual infiltration) Report pain during treatment using the HP-VAS Undergo monitoring of SpO₂ and pulse via pulse oximetry To control for cortisol fluctuations and circadian rhythm, all procedures and saliva collections will occur between 09:00-12:00. Participants will be asked to avoid food for at least 2 hours prior, and refrain from caffeine, alcohol, smoking, or heavy exercise for at least 24 hours before treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years
- •Systemically healthy individuals who agree to participate in the study
- •Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis requiring root canal treatment
- •Teeth with closed apex and no periapical lesions visible radiographically
- •Periodontally healthy teeth according to Glickman's criteria, with probing depth ≤ 3 mm
- •Teeth with mobility less than 0.5 mm
- •Patients experiencing moderate (55-113 mm) or severe pain (114-170 mm) according to the Heft-Parker Visual Analog Scale (HP-VAS)
排除标准
- •Patients with any systemic disease
- •Teeth with open apex or radiographic evidence of periapical pathology
- •Teeth showing internal or external root resorption
- •Teeth that do not meet Glickman's periodontal health criteria or have probing depth > 3 mm
- •Teeth with mobility greater than 0.5 mm
- •Patients experiencing no pain (0 mm) or mild pain (1-54 mm) on the HP-VAS
结局指标
主要结局
Success Rate of Mandibular Anesthesia
时间窗: Within 30 minutes after anesthesia administration, during the endodontic procedure
The success of inferior alveolar nerve block (IANB) will be determined based on the patient's pain response during endodontic treatment, measured using the Heft-Parker Visual Analog Scale (HP-VAS). Anesthesia will be considered successful if pain during treatment is rated as "none" or "mild" on HP-VAS.
次要结局
- Correlation Between Dental Anxiety Level and Anesthesia Success(At the end of the single treatment session (within 30 minutes after anesthesia administration))
- Salivary Cortisol Level Change(Pre-anesthesia and 15 minutes post-anesthesia)