Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 主要终点
- Pain score after local anesthesia administration, dental procedure, and 48 hours postoperatively.
研究概览
简要总结
The purpose of the Research Study and Overview of Participation: This study will compare different approaches used to prevent pain when giving local anesthesia to numb the teeth while managing dental cavities and decay. Specifically, it seeks to determine which approach will reduce the pain and discomfort during or after the procedure. This will help dentists to choose the best approach to reduce patient's pain and discomfort and improve the overall experience of dental treatment.
Participants in the study would likely undergo the following:
- Screening and Consent: Participants would be assessed for eligibility (e.g., age, health status, and presence of dental caries requiring treatment) and would provide informed consent.
- Intervention: Participants would be randomly assigned to different groups based on the type or method of topical anesthesia being tested.
- Treatment Procedure: Dental caries management would be performed under local anesthesia, with the designated topical anesthetic applied beforehand.
- Pain Assessment: Participants would rate their pain levels during and after the procedure using validated pain measurement scales (e.g., visual analog scale).
- Follow-Up: Participants might be monitored for a short duration post-treatment to assess any residual pain or side effects.
This design ensures that the study collects reliable data on the effectiveness of the different topical anesthetic approaches while prioritizing patient safety and comfort.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy participants: American Society of Anesthesiology Class I or II
- •Adults aged 18-59 years
- •No history of allergy to local anesthesia or excipients included in the vial
- •Participant requiring caries management for a maxillary premolar tooth (ICDAS I-V), with reversible pulpitis.
排除标准
- •American Society of Anesthesiology Class III or higher
- •Participants with systemic conditions affecting pain perception
- •Participants on chronic pain medication
- •Pregnant or breastfeeding women
- •History of allergy to topical/local anesthesia
- •Taking any analgesic 48 hours before testing, such as an NSAID, opioids, or
- •acetaminophen
- •Recent oral trauma
- •Deep carious lesion with irreversible pulpitis or pulpal necrosis
研究组 & 干预措施
Non-medicated anelgesia
干预措施: Photobiomodulation (PBM)-induced analgesia device using multi-wavelength LED (Device)
Placebo
Placebo
干预措施: Placebo (Other)
Medicated anelgesia
干预措施: Medicated analgesia (Other)
结局指标
主要结局
Pain score after local anesthesia administration, dental procedure, and 48 hours postoperatively.
时间窗: Within 5 minutes after local anesthesia administration, during dental procedure, directly after finishing the procedure, and 48 hours postoperatively.
Pain score based on Visual Analog Scale (1-10) with highest score indicates the most severe pain.
次要结局
- Pain score with prick pain test (PPT)(One minute after topical anesthesia.)
- Pain score with pulpal stimulation using electric pulp tester (EPT)(After 2 minutes of topical anesthesia.)
- Amount of local anesthesia to be given(At the end of dental procedure.)
- Need for additional analgesics(Within 48 hours postoperatively.)
- Reporting of any adverse effects, such as mucosal irritation, allergic reactions, and delayed pain relief.(Within 48 hours postoperatively.)
研究者
Sameeha Husain Al Marzooqi
Consultant
Dubai Health