Effect of Oral Valaciclovir on Inter- Appointment Endodontic Pain in Single-Rooted Necrotic Teeth With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pain intensity measured by Visual Analog Scale (VAS)
研究概览
简要总结
Aim: To investigate the effect of oral valacyclovir on inter-appointment endodontic pain in single-rooted necrotic teeth diagnosed with symptomatic apical periodontitis (SAP).
Materials and Methods: This study was a randomized, triple-blind, placebo-controlled clinical trial conducted on 38 teeth. Participants were assigned to intervention or control groups using stratified randomization based on gender and baseline pain severity. Both groups received similar root canal treatment; the only difference was the administration of valacyclovir in the intervention group and placebo in the control group. Patients' pain levels were monitored and recorded at 6, 24, and 48 hours post-treatment using a Visual Analog Scale (VAS), along with their consumption of analgesic (ibuprofen).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 60 years of age
- •Require primary root canal treatment (RCT) in single-rooted maxillary or mandibular teeth (anterior or posterior)
- •Diagnosed with symptomatic apical periodontitis (SAP) with confirmed pulp necrosis
排除标准
- •Teeth with unrestorable crowns
- •Presence of endodontic-periodontal or pure endodontic lesions
- •Complex root canal anatomies as defined by the AAE Endodontic Case Difficulty Assessment Form
- •Internal or external root resorption
- •Calcified canals
- •Root canal configuration other than Vertucci's Type I
- •Pain originating from more than one tooth
- •Marginal periodontitis
- •Parafunctional habits
- •Systemic diseases classified as ASA class II or higher
- •Diagnosed migraine or other headache disorders mimicking orofacial pain
- •Intellectual or cognitive impairments
- •Pregnancy or breastfeeding
- •Use of medications affecting pain perception
- •Current use of antibiotics or antiviral agents
- •Known allergies to study medications
研究组 & 干预措施
placebo group
干预措施: Placebo (Drug)
valacyclovir group
干预措施: Valacyclovir (Drug)
结局指标
主要结局
Pain intensity measured by Visual Analog Scale (VAS)
时间窗: 6, 24, and 48 hours post-treatment
The Visual Analog Scale (VAS) is a commonly used tool for assessing pain intensity in patients. In this method, the patient is asked to indicate the perceived level of pain on a 10-centimeter horizontal line, where 0 represents "no pain" and 10 denotes "the worst pain imaginable." Based on the scores provided by patients, pain intensity is categorized into three levels: scores from 0 to 3 indicate mild pain, 4 to 7 indicate moderate pain, and 8 to 10 indicate severe pain.
次要结局
- Proportion of participants requiring ibuprofen as rescue analgesic(Within 48 hours post-treatment)