Comparative evaluation of vibratory toothbrush and photobiomodulation with topical anesthetic gel as preanesthetic tissue management in 5–12-year-old children undergoing dental procedure – an in vivo study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- methods to reduce local anesthetic injection pain
研究概览
简要总结
Subjects who fulfill inclusion criteria will be selected and prepared to receive and respond to three preanesthetic tissue management methods.
Method 1 is using topical anesthetic gel in this some amount of gel applied directly onto a cotton swab and applied for 1 minute. Immediately after this, local anesthesia is given.
Method 2 is using vibratory toothbrush. This vibration will be given for 1 minute before injection. Provide vibrations close to injection site as feasible with head’s bristles facing the oral mucosa.
Method 3 is using photobiomodulation; in this, a diode laser epic X biolase technology from the USA with 0.2 W power and 940nm wavelength for 60 sec using continuous wave mode, both the operator and the patient should wear safety goggles while the laser is being radiated. After 60 sec, a local anesthetic injection is given.The local anesthesia given will be 2% lignocaine hydrochloride with 1:20000 adrenaline using a 27 gauge short needle with slow speed of 60 sec.Infiltration injection will be performed on the buccal gingiva of the approximated position of the root apex of the related. 0.5ml of anesthetic solution should be deposited in the supraperiosteal area. Buccal infiltration should be supplemented with palatal or lingual infiltration.
The outcome is assessed using subjective and objective methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with age range between 5 and 12 years old.2)Children with written informed consent forms given by a parent or guardian.3)Childrens dental behavior score of 3 or 4 according to the Frankel behavior rating scale.4)Children who need local anesthesia for dental treatment in three quadrants of the oral cavity.
排除标准
- •History of allergy to material used for anesthesia and sulfite.2)Children who have any systemic disease or special health care need.
- •Presence of any inflammation or lesion at the site of injection.4)Children who had previous bad experiences with dentistry.
- •Children presenting for emergency treatment of dental pain.
结局指标
主要结局
methods to reduce local anesthetic injection pain
时间窗: 2years
次要结局
- experience during local anesthetic injection(2 years)
- • To evaluate the effectiveness of a vibratory toothbrush with topical anesthetic gel for reducing local anesthetic injection pain.(• To evaluate the effectiveness of photobiomodulation with topical anesthetic gel for reducing local anesthetic injection pain.)
研究者
ANAGHA SURESH
MAR BASELIOS DENTAL COLLEGE