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临床试验/CTRI/2024/10/075310
CTRI/2024/10/075310已完成不适用

Evaluation of low level laser therapy on pain perception and anxiety levels in conventional local anesthesia injection.

G.lalasa1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
To assess HAM-A, VAS and WBFR in both groups.

研究概览

简要总结

Periodontal diseases are a range inflammatory diseases caused due to bacterial buildup. If left untreated these diseases can lead to the deterioration of tooth supporting structures and eventually tooth loss. Depending upon the severity of the disease periodontal treatment can be restricted to nonsurgical or could involve surgical intervention. Both treatments could be an unpleasant experience for the patients and hampers the patient’s day to day activity. Several strategies can be used to reduce pain perception in dental anesthetic injection, including the use of a higher gauze needle, slow speed of anesthetic injection, optimization of the pH at the injection site, and selection of a proper type of anesthetic agent. Low level laser therapy (LLLT) recently named as photobiomodulation therapy (PBMT) is a form of non-thermal light therapy with several clinical outcomes in favor of pain and inflammation reduction, immunomodulation, and tissue regeneration. LLLT is a monochromatic and coherent light of single wavelength, which works on the principle of photobiostimulation of the cells. This effect causes modifications in the function of cells and tissues. Following the absorption of light by the cellular photo-acceptors, cell reaction and proliferation and protein synthesis, vasodilatation and activation of several signaling pathways takes place. The optimal laser wavelengths for the therapeutic effects are usually in the red to near infrared spectrum (600 to 1000nm) with an energy density up to 10J/cm2 on the target sites, which has been confirmed to stimulate biological process.The use of LLLT to decrease the level of pain perception during injection. The use of LLLT to reduce pain of injection of the local anesthetic agent in the oral cavity is not yet well established. Therefore the purpose of this study was to evaluate the effect of LLLT before needle insertion in an adult population in reducing pain of injection of the local anesthetic agent. Subjects will be assessed based on inclusion and exclusion criteria. Subjects with maxillary bilateral surgical intervention in a split-mouth design will be performed. Prior to injection low level laser therapy (LLLT) application will be performed in non contact pulse mode at the selected site in Group I, The irradiation was done by using a hand piece 0.5cm2 spot size  at 650nm wavelength, with 5/J of energy for 25 sec at a1mm distance. In the Group II, laser irradiation will be done for 25 sec similar to the Group I in off mode. For safety, laser irradiation will be carried out with use of protection eyewear. Later 2% lidocaine plus 1: 100000 epinephrine was injected with conventional needle at a speed of 1ml/min by operator in both the groups.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients who are apparently healthy.
  • Patients requiring bilateral periodontal therapy.

排除标准

  • Patients under medication.
  • Pregnant or lactating females
  • Drug and alcohol abuse.
  • Tobacco users
  • Patients who are allergic to local amide anesthetics.

结局指标

主要结局

To assess HAM-A, VAS and WBFR in both groups.

时间窗: baseline, after application

次要结局

  • Hamilton anxiety ating scale, visual analogue scale, wong becker faces rating rate(baseline, after application)

研究者

发起方
G.lalasa
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr G Lalasa

Sibar Institute Of Dental Sciences

研究点 (1)

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