Introduction: 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.
Methods And Analysis: 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.
Secondary Outcomes: 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.
Ethics And Dissemination: 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.
Trial Registration: ClinicalTrials.gov (Registration number: NCT03412721).
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6320132 | PMC |
http://dx.doi.org/10.1097/MD.0000000000013601 | DOI Listing |
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