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Lactobacillus brevis CD2 attenuates traumatic oral lesions induced by fixed orthodontic appliance: A randomized phase 2 trial
Author(s) -
Silva Nathália Louize Nunes Vieira,
Della Bona Alvaro,
Cardoso Moisés,
CallegariJacques Sidia Maria,
Fornari Fernando
Publication year - 2021
Publication title -
orthodontics and craniofacial research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.664
H-Index - 55
eISSN - 1601-6343
pISSN - 1601-6335
DOI - 10.1111/ocr.12448
Subject(s) - placebo , medicine , lactobacillus brevis , quality of life (healthcare) , randomized controlled trial , lesion , clinical trial , probiotic , oral health , dentistry , surgery , pathology , lactic acid , alternative medicine , nursing , biology , bacteria , genetics , lactobacillus plantarum
Objective To evaluate the effect of the probiotic Lactobacillus brevis CD2 on the prevention of early traumatic oral lesions induced by a fixed orthodontic appliance. Settings and Sample Population Twenty orthodontic patients (14‐57 yo) were recruited from a private clinic. Subjects and Methods In a phase 2, double‐blind clinical trial, all patients were randomly allocated (1:1 ratio) to a 21‐day course of soluble tablets containing L brevis CD2 (4 billion colony‐forming units after breakfast, lunch and dinner) or placebo, starting at the day of orthodontic appliance placement. The primary outcomes were days with oral lesions and lesion‐related pain [ranging between 0 (no pain) and 10 (maximum pain)]. Oral health‐related quality of life was measured using OHIP‐14 before and after treatments. Results All patients completed the study. Ten were treated with L brevis (28.1 ± 13.3 yo, 70% women), and 10 received placebo (27.5 ± 9.1 yo, 60% women). The oral lesions lasted significantly less time ( P = .018) in patients treated with L brevis (2.5 ± 1.0 days) than with placebo (4.9 ± 3.0 days). Pain score was significantly lower ( P = .039) when L brevis was used [median (min‐max): 0 (0‐4) vs. 3 (0‐5)]. OHIP‐14 scores were not significantly different between treatments. Conclusions Lactobacillus brevis CD2 reduced almost 50% the persistence of traumatic oral lesions in patients with fixed orthodontics. Yet, there was no improvement in quality of life compared to placebo, suggesting that such differences in persistency and pain related to oral lesions may be considered clinically irrelevant.