Veneva Elitsa, Raycheva Ralitsa, Belcheva Ani
Department of Pediatric Dentistry, Faculty of Dental Medicine.
Department of Social Medicine and Public Health, Faculty of Public Health, Medical University - Plovdiv, Bulgaria.
Medicine (Baltimore). 2018 Dec;97(51):e13601. doi: 10.1097/MD.0000000000013601.
A current non-pharmacological mean for attaining painless conservative treatment is presented by laser analgesia (LA), considered as bio-photomodulation of pulp reactivity aiming reduction of nociceptive impulse formation. Currently no consensus is reached regarding a detailed protocol with laser parameter settings for pre-emptive LA. The purpose of this study is determining the efficacy of erbium-doped yttrium aluminium garnet (Er:YAG) laser in achieving pulpal analgesia and quantifying duration and extent of any effects assessed.
The proposed study is a double-blind placebo-controlled randomized split-mouth clinical trial with 2-way repeated measures design. Eligible patients of age 10 to 12 years undergo 2 single-visit treatments, receiving LA or placebo analgesia (PA) prior to caries ablation, randomized via computer-generated, permuted-block sequence. Primary outcome measure is pain felt during treatment, reported by patient on visual-analogue scale.
changes in pulpal sensibility to electrical and cold-stimuli; patient experience during LA/PA; pain-related behavior according to Faces, Legs, Activity, Cry, Consolabilty (FLACC) scale; heart-rate dynamics. Data will be analyzed with intention-to-treat concept by Student t test for paired samples, P < .05. Pre-test on 20 subjects resulted in n = 41 patients needing to be recruited.
This study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval N:6/23.11.2017) and registered on a publically accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants.
ClinicalTrials.gov (Registration number: NCT03412721).
激光镇痛（LA）是一种当前用于实现无痛保守治疗的非药物手段，被视为牙髓反应性的生物光调制，旨在减少伤害性冲动的形成。目前，关于预先镇痛性激光镇痛的详细激光参数设置方案尚未达成共识。本研究的目的是确定掺铒钇铝石榴石（Er:YAG）激光实现牙髓镇痛的疗效，并量化所评估的任何效果的持续时间和程度。
拟进行的研究是一项双盲、安慰剂对照、随机分组的口内临床试验，采用双向重复测量设计。年龄在10至12岁的符合条件的患者接受两次单次就诊治疗，在龋齿消融前接受激光镇痛或安慰剂镇痛（PA），通过计算机生成的置换区组序列进行随机分组。主要结局指标是患者在治疗期间通过视觉模拟量表报告的疼痛感受。
牙髓对电刺激和冷刺激的敏感性变化；患者在激光镇痛/安慰剂镇痛期间的体验；根据面部、腿部、活动、哭闹、安慰度（FLACC）量表评估的疼痛相关行为；心率动态变化。数据将采用意向性分析概念，通过配对样本的Student t检验进行分析，P<0.05。对20名受试者进行的预试验结果表明，需要招募n = 41名患者。
本研究方案已获得保加利亚普罗夫迪夫医科大学科研伦理委员会批准（参考编号P - 8604，批准协议编号：6/23.11.2017），并已在可公开访问的数据库中注册。本研究获得了保加利亚普罗夫迪夫医科大学的机构资助，项目编号为SPD - 03/2017。研究结果将在科学出版物、研究会议以及面向参与者的项目总结报告中公布。
ClinicalTrials.gov（注册号：NCT03412721）。
