Comparative Evaluation of Application of Topical Anesthetic Gel, Solution and Cryotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants with Eased Injection Pain
研究概览
简要总结
In this study, the investigators aimed to compare the effects of topical anesthetic materials and cold application on pain perception. The main questions it aims to answer are:
- Is cold application is effective as a topical anesthetic replacement?
- Is there a difference on pain perception between cold and room temperature topical anesthetic?
The treatment contains of participants selected from a group of patients who requires dental treatment. The mission of the participants is to answer the questionnaires correctly and cooperate the treatment. Participants will be divided into 4 groups containing 25 child per group:
- First group: topical anesthetic spray solution.
- Second group: topical anesthetic gel
- Third group: Cryotherapy as distilled water
- Fourth group: Cryotherapy as topical anesthetic spray solution. All participants will answer questionnaire of pain, anxiety and taste. The oxygen saturation and pulses will be measured with a pulse-oxymeter device to be recorded.
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
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7 to 10 years old,
- •Literate,
- •ASA score 1 and 2,
- •FRANKL score 3 and 4
- •Modified Dental Anxiety score less than 19,
- •Not allergic to the active ingredient of the topical anaesthetics used
- •Indication for treatment of primary teeth,
- •Children who have never had dental treatment under local anaesthesia,
- •Patients who agree to participate in the study will be included in the study
排除标准
- •Not between the ages of 7 and 10,
- •Illiterate,
- •ASA score greater than 2,
- •FRANKL score 1 and 2
- •Modified Dental Anxiety score greater than 19,
- •Known allergy to the active ingredient of the topical anaesthetics used
- •Children with previous dental experience will not be included in the study
研究组 & 干预措施
Topical Anesthetic Solution
In spray group, as a topical anaesthetic solution containing 10% lidocaine will be applied to the injection site with the help of a pressel for 20 seconds after the application area is dried by squeezing a cotton pellet. The taste/odour evaluation of the applied topical anaesthetic material will be measured with the 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before topical anaesthesia application, during topical anaesthesia application and injection.
干预措施: topical anesthetic (Drug)
Topical Anesthetic Gel
In topical anesthetic gel group, a gel containing %20 benzocain with strawberry aroma, will be applied to the injection site with the help of a pressel for 20 seconds after the application area is dried by squeezing a cotton pellet. The taste/odour evaluation of the applied topical anaesthetic material will be measured with the 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before topical anaesthesia application, during topical anaesthesia application and injection.
干预措施: Topical anesthetic gel (Drug)
Cryotherapy as Distilled Water
As cryotherapy material, distilled water solution will be cooled in the refrigerator at +4 degrees, removed from the refrigerator just before the application and a cotton swab will be wetted with this solution and applied to the area. The taste/odour evaluation of the applied topical anaesthetic material will be measured with 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before, during and after topical anaesthesia application and injection.
干预措施: Cryotherapy (Drug)
Cryotherapy as Anesthetic Solution
The topical anaesthetic solution will be stored in the refrigerator at +4 degrees Celsius, removed from the refrigerator just before the application and a cotton swab will be wetted with this solution and applied to the area. The taste/odour evaluation of the applied topical anaesthetic material will be measured with 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before, during and after topical anaesthesia application and injection.
干预措施: Cryotherapy (Drug)
Cryotherapy as Anesthetic Solution
The topical anaesthetic solution will be stored in the refrigerator at +4 degrees Celsius, removed from the refrigerator just before the application and a cotton swab will be wetted with this solution and applied to the area. The taste/odour evaluation of the applied topical anaesthetic material will be measured with 3 Category Hedonic Scale. After sufficient numbness is achieved, local infiltrative injection will be performed. Anxiety levels will be evaluated by measuring with the same parameters before, during and after topical anaesthesia application and injection.
干预措施: topical anesthetic (Drug)
结局指标
主要结局
Number of Participants with Eased Injection Pain
时间窗: From the beginning of the topical anesthetic implementation to the injection
During the procedure, all of the data of the participants containing oxygen saturation, pulse and questionnaire about their experience will be collected to assess the statistical differences between groups.
次要结局
未报告次要终点
研究者
Bilal OZMEN
Assoc.Prof.Bilal OZMEN
Ondokuz Mayıs University