Efficacy of erbium-doped yttrium aluminium garnet for achieving pre-emptive dental laser analgesia in children A study protocol for a randomized clinical trial

• Published in: Medicine (Baltimore) Vol. 97; no. 51; p. e13601
• Main Authors: Veneva, Elitsa, Raycheva, Ralitsa, Belcheva, Ani
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer Health 01.12.2018
• Subjects: Ablation Techniques - adverse effects; Ablation Techniques - methods; Analgesia - methods; Child; Dental Caries - surgery; Double-Blind Method; Female; Humans; Lasers, Solid-State - therapeutic use; Male; Pain, Procedural - epidemiology; Pain, Procedural - etiology; Pain, Procedural - prevention & control; Preoperative Care - methods; Randomized Controlled Trials as Topic; Study Protocol Clinical Trial; Treatment Outcome
• ISSN: 0025-7974; 1536-5964; 1536-5964
• 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).