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临床试验/CTRI/2024/11/077228
CTRI/2024/11/077228尚未招募3 期

A Comparative Evaluation of The Effect of Low-Level LASER Therapy, LASER-Activated Irrigation and Preoperative Aceclofenac on Post Endodontic Pain After Single Visit Root Canal Treatment - A Randomized Controlled Trial.

Dr Aditi Wasule1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年12月3日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
post operative pain

研究概览

简要总结

Pain after endodontic treatment is a common side effect with significant effect on the quality of life of the patients. Pretreatment analgesia is providing analgesia to patients before endodontic treatment is started. This technique can decrease the establishment of central and peripheral sensitization, which has the potential to reduce postoperative pain and postoperative analgesic intake. The controlled-release formulation of Aceclofenac allows the drug to be effective over an extended period. It also reduces repeated administration of the drug and allows for better patient compliance.  Laser-activated irrigation (LAI) generates optical cavitation in the irrigant, causing the formation of vapor bubbles. LAI is very effective in debris removal from canal complexities which occurs exceedingly fast, causing a very rapid turbulence in the liquid throughout the whole canal. Moreover, LAI showed reduced postoperative pain and discomfort following endodontic treatment in single visit which was attributed to the technique’s low intra-canal pressure, which does not exceed the pressure in the apical tissues or the 5.88 mmHg central venous pressure. Low-level LASER therapy (LLLT)  increases endogenous endorphins (β-endorphin) and decreases the activity of C-fibers and bradykinin, and thus creates an analgesic effect. LLLT application also increases phagocytic activity, number and diameter of lymphatic vessels, decreases the permeability of blood vessels, thus reducing edema and post-operative symptoms. This treatment is nowadays called “photobiomodulation”, also referred to as “LLLT” in literature. Thus, this study compares the various modalities for pain reduction like low-level LASER Therapy, LASER-activated irrigation and administration of preoperative Aceclofenac.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Healthy patients aged between 18-40 years.
  • Permanent mandibular premolars with complete root formation.
  • Permanent mandibular premolars with diagnosis of symptomatic irreversible pulpitis with symptomatic apical periodontitis.
  • Permanent mandibular premolars indicated for primary root canal treatment with Periapical Index Score (PAI) of 1 or 2.

排除标准

  • Patients who are medically compromised.
  • Patients who had taken antibiotics in last 1 month and non-steroidal anti-inflammatory drugs 24 hours prior to procedure.
  • Patients contraindicated for Aceclofenac, Lignocaine, use of apex locator and patients allergic to latex.
  • Pregnant and lactating women.
  • Adjacent carious teeth.
  • Immature teeth or teeth with root resorption.
  • Teeth with calcified canals.
  • Teeth with sinus opening or periapical radiolucency with PAI score of 3 or higher.

结局指标

主要结局

post operative pain

时间窗: 6hrs, 24hrs, 48hrs, 72hrs

次要结局

  • no. of analgesics taken(6hrs, 24hrs, 42hrs, 72hrs)

研究者

发起方
Dr Aditi Wasule
申办方类型
Other [self sponsored]
责任方
Principal Investigator
主要研究者

Dr Aditi Wasule

Government Dental College and Hospital, Nagpur

研究点 (1)

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