The Effect of Er,Cr:YSGG Laser-assisted Topical Anesthetic on Oral Mucosal Anesthesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Insertion Depth at Initial Sensory Detection
研究概览
简要总结
This study tests whether using an Er,Cr:YSGG laser before applying numbing gel (lidocaine) can help reduce pain during dental procedures compared to traditional methods. Investigators want to know:
Does the laser make the numbing gel work better and longer?
Does it lower pain and keep patients calmer (measured by heart rate)?
Investigators enrolled 20 adults (10 men, 10 women) and assigned them to three groups:
Laser + Numbing Gel: Laser was used on the gums before applying lidocaine.
Sham Laser + Numbing Gel: A fake laser was used with lidocaine.
Sham Laser + Vaseline: A fake laser was used with Vaseline (no numbing effect).
Participants reported pain levels on a scale (0=no pain, 10=worst pain) when a tiny needle touched their gums. Investigators also checked their heart rate.
详细描述
Participants will be invited to participate in a study observing the anesthetic efficacy of the combination of Er,Cr:YSGG laser and surface anesthetic agent on the oral mucosa. This informed consent form provides participants with detailed information to help participants decide whether to participate in this project. Please read it carefully. If participants have any questions, please raise them to the researcher in charge of the study. Investigators will give participants a comprehensive explanation.
Participants' participation in this study is voluntary. This research has been reviewed by the ethics committee of this research institution.
Research purpose: By measuring the anesthetic depth of the combined use of Er,Cr:YSGG water laser and surface anesthetic agent at different time points in the oral vestibule of the mandibular anterior teeth area, to observe the anesthetic efficacy of the combined use of Er,Cr:YSGG water laser and surface anesthetic agent on the oral mucosa.
Research content and process: Before participants are selected for the study, the doctor will ask about participants basic situation, record participants' medical history, and conduct a routine oral examination. The specific requirements are: no allergy to anesthetic drugs, no mucosal lesions, no pregnancy, no systemic diseases, and good health condition.
If participants' above examinations are qualified, participants will follow the following steps for the study: Rest for half an hour to stabilize blood pressure and heart rate. The nurse will put an electrocardiogram monitor on participants to record the changes in blood pressure and heart rate throughout the process. The doctor will select three sites in the vestibule of the mandibular anterior teeth area and irradiate 1 cm away from the site at a 90-degree angle with water laser or ineffective laser for 1 minute, and then randomly apply lidocaine or vaseline to the three sites. The subjects will not rinse their mouths during the experiment. The doctor will insert an aseptic needle into the mucosa at three sites in the mandibular anterior teeth area 10 minutes, 20 minutes, 30 minutes, 40 minutes and 50 minutes after irradiation, and the subjects will raise their hands to indicate "feeling" or "pain" to stop the needle insertion. The doctor will record the depth of needle insertion.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •could understand and follow given instructions
排除标准
- •excessive dental anxiety
- •anesthesia allergies
- •mucosal lesions
- •cardiovascular disease
- •pregnancy or lactation
- •severe psychiatric disorders
- •hearing abnormalities
- •speech dysfunction
研究组 & 干预措施
Laser + Lidocaine
One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received irradiation with a 2780 nm, 1.0 W Er,Cr:YSGG laser for 1 minute followed by application of 2% lidocaine gel.
干预措施: Lidocaine (Drug)
Sham Laser + Lidocaine
One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received sham laser irradiation for 1 minute followed by application of 2% lidocaine gel.
干预措施: Sham Laser irradiation (Drug)
Sham Laser + Lidocaine
One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received sham laser irradiation for 1 minute followed by application of 2% lidocaine gel.
干预措施: Lidocaine (Drug)
Sham Laser + Vaseline
One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received sham laser irradiation for 1 minute followed by application of Vaseline.
干预措施: Sham Laser irradiation (Drug)
Sham Laser + Vaseline
One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received sham laser irradiation for 1 minute followed by application of Vaseline.
干预措施: Vaseline (Drug)
结局指标
主要结局
Insertion Depth at Initial Sensory Detection
时间窗: 10, 20, 30, 40, and 50 minutes
Insert a sterile needle into the mucosa at the sites. Record the Insertion depth when participants perceived an "initial sensory detection"
Pain Score at Initial Sensory Detection
时间窗: 10, 20, 30, 40, and 50 minutes
Insert a sterile needle into the mucosa at the sites. Record the pain score when participants perceived an "initial sensory detection". Evaluated with a linear visual analog scale. "0" represents no pain, and "10" represents the most intense pain imaginable.
Heart Rate
时间窗: 10, 20, 30, 40, and 50 minutes
Insert a sterile needle into the mucosa at the sites. Record the heart rate with an electrocardiogram monitor when participants felt "pain".
Insertion Depth at Pain
时间窗: 10, 20, 30, 40, and 50 minutes
Insert a sterile needle into the mucosa at the sites. Record the Insertion depth when participants felt "pain".
Pain Score at Pain
时间窗: 10, 20, 30, 40, and 50 minutes
Insert a sterile needle into the mucosa at the sites. Record the pain score when participants felt "pain". Evaluated with a linear visual analog scale. "0" represents no pain, and "10" represents the most intense pain imaginable.
次要结局
未报告次要终点
研究者
Li Zhen Zhong
Master Student
First Affiliated Hospital of Jinan University
