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临床试验/NCT07703553
NCT07703553已完成不适用

Comparison of Pre-Anesthetic Approaches to Reduce Needle Insertion Pain Before Dental Local Anesthesia.

Harran University1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2026年2月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
192
试验地点
1
主要终点
Pain intensity during initial needle insertion (VAS)

研究概览

简要总结

The main purpose of this study is to find out which pre-treatment method works best to reduce pain from dental anesthesia injections in adult patients. Researchers will compare four different approaches:

Topical numbing spray (10% lidocaine) Brief cold application (cryotherapy) A combination of both cold application and cooled numbing spray A control group Participants who need a standard local anesthesia injection for their dental treatment will be randomly assigned to one of these four groups. Right after the needle insertion, participants will rate their pain level using a simple visual scale, and their physical reactions will also be observed and scored by the researchers.

详细描述

Local anesthesia injection is one of the stages that causes the most fear and discomfort in patients during dental procedures. While topical anesthetics are widely used to reduce this discomfort, their effectiveness can be limited. Cryotherapy is a simple and economical method that provides short-term analgesia by slowing nerve conduction and raising the pain threshold. Although the literature shows that cryotherapy is effective in reducing injection pain in pediatric patients, randomized controlled trials comparing different methods in adult individuals are limited. Fear of needles and injection pain are important factors that negatively affect compliance with dental treatment. Proving the effectiveness of simple, inexpensive, and side-effect-free methods will increase patient comfort and elevate treatment success in clinical practice. In particular, the combination of cryotherapy and a topical anesthetic can minimize injection pain by providing a stronger analgesic effect. This study aims to fill the gap in the literature regarding adult patients by revealing the comparative effectiveness of different pre-anesthetic approaches in pain control before dental local anesthesia. In this prospective, randomized, controlled clinical trial, adult participants will be randomly divided into four groups to evaluate the pre-anesthetic protocols: Topical anesthetic spray group: Application of 10% lidocaine spray to the mucosa. Cold application group: Gentle contact of an ice pen (cryotherapy) to the mucosa for 60 seconds. Combination group: Cold application for 60 seconds, followed by the application of cooled 10% lidocaine spray. Control group: Standard procedure with a placebo control. Following the pre-anesthetic mucosal preparation, standard local anesthesia will be administered using 1.8 mL of 4% articaine with 1:100,000 epinephrine. Pain measurements will be conducted separately for three different injection sites: mandibular block anesthesia, buccal infiltrative anesthesia in anterior and posterior regions, and palatal infiltration anesthesia. During the initial needle insertion, pain levels will be assessed subjectively using a Visual Analog Scale (VAS) and objectively by the researchers using the Sound-Eye-Motor (SEM) scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Adults aged between 18 and 65 years.
  • Systemically healthy individuals classified as ASA I or II.
  • Patients presenting to the Harran University Faculty of Dentistry Hospital who require local anesthesia during dental treatment.
  • Treatment plan requiring mandibular block anesthesia, anterior/posterior infiltration, or palatal infiltration.
  • No regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
  • No history of allergy to cold application or topical anesthetics.

排除标准

  • Regular use of analgesics (NSAIDs, paracetamol, etc.) within the last 7 days.
  • Chronic pain syndrome, migraine, or systemic diseases requiring continuous use of analgesics.
  • Pregnancy or lactation.
  • Presence of active lesions in the oral mucosa, severe periodontal infection, or pathology at the injection site.
  • History of allergy to topical gel or cold application.
  • Psychiatric disorders or conditions preventing compliance with dental treatment.

研究组 & 干预措施

Topical Anesthetic Spray

Experimental

Application of 10% lidocaine spray to the oral mucosa before local anesthesia.

干预措施: 10% lidocaine spray (Drug)

Control

No Intervention

Standard local anesthesia injection without any pre-anesthetic intervention.

Combination Arm Type: Experimental

Experimental

Application of an ice pen for 60 seconds followed by 10% lidocaine spray before local anesthesia.

干预措施: 10% lidocaine spray (Drug)

Cryotherapy

Experimental

Application of an ice pen to the oral mucosa for 60 seconds before local anesthesia.

干预措施: Ice Pen (Cryotherapy) (Other)

Combination Arm Type: Experimental

Experimental

Application of an ice pen for 60 seconds followed by 10% lidocaine spray before local anesthesia.

干预措施: Ice Pen (Cryotherapy) (Other)

结局指标

主要结局

Pain intensity during initial needle insertion (VAS)

时间窗: During the initial local anesthesia needle insertion.

Subjective pain levels will be assessed by participants using a Visual Analog Scale (VAS) ranging from 0 to 10 mm. Higher scores indicate greater pain.

次要结局

  • Objective pain assessment using Sound-Eye-Motor (SEM) scale(During the initial local anesthesia needle insertion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet AKAY

Assistant Professor

Harran University

研究点 (1)

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