Valacyclovir Monotherapy in Pain Management of Acute Apical Abscesses After Performing Emergency Chamber Opening; A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Changes in pain score using Numeric Rating Scale (NRS)
研究概览
简要总结
This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .
There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days
详细描述
BACKGROUND:
Acute apical abscess is an inflammatory reaction to pulpal infection and necrosis characterized by rapid onset, spontaneous pain, extreme tenderness of the tooth.. Recently, it has been hypothesized that Herpesvirus infection can contribute to the pathogenesis of apical periodontitis. In symptomatic forms of apical periodontitis, the etiology can be same as it is for marginal periodontitis.
OBJECTIVE:
The aim of this study is to test the valacyclovir treatment on patients with acute apical abscess, as it might help reducing pain and the need for analgesics
METHODOLOGY:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Age ≥18 years old
- •Healthy patient American Society of Anesthesiologists (ASA) class l and ll.
- •Patients having clinical evidence of pulp necrosis and acute apical abscess with radiographic signs of periapical disease.
- •Main inclusion criteria is that patient should have moderate to severe pain, it can be calculated as:
- •1 to 3 as Mild pain. 4 to 6 as moderate pain. 7 to 10 as severe pain.
排除标准
- •Patient currently on antibiotics or antivirals
- •Unusual tooth anatomy or inaccurate diagnosis
- •Pregnant or nursing mothers
- •Patients allergic to valacyclovir
研究组 & 干预措施
Valacyclovir Group
participants will be given prescription of valacyclovir (2g immediate dose followed by 500mg 2 times daily for 3 days) along with the analgesic, Naproxen sodium, 550mg (SOS, if needed) Data will be recorded daily for 6 days
干预措施: Valacyclovir 500 mg (Drug)
Control Group
this is control group and is prescribed with analgesic, Naproxen sodium, 550mg (SOS, if needed) only
干预措施: Naproxen Sodium 550mg (Drug)
结局指标
主要结局
Changes in pain score using Numeric Rating Scale (NRS)
时间窗: 6 days
NRS measures the pain extremes between 0-10 (0=no pain while 10= extreme pain)
次要结局
未报告次要终点
研究者
Yumna Shaheen
Principal Investigator
Dow University of Health Sciences