Lactobacillus brevis CD2 attenuates traumatic oral lesions induced by fixed orthodontic appliance: A randomized phase 2 trial.
- 2020-12-14
- Orthodontics & Craniofacial Research 24(3)
- Nathália Louize Nunes Vieira Silva
- Á. Della Bona
- M. Cardoso
- S. Callegari-Jacques
- F. Fornari
- PubMed: 33259688
- DOI: 10.1111/ocr.12448
Abstract
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.
Keywords: Lactobacillus brevis CD2; fixed orthodontic appliance; oral pain; randomized trial; traumatic oral lesions.
Research Insights
| Supplement | Health Outcome | Effect Type | Effect Size |
|---|---|---|---|
| Lactobacillus brevis | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis HA-112 | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis HA-112 | Reduced Oral Health-Related Quality of Life | Neutral | Small |
| Lactobacillus brevis HA-112 | Reduced Oral Pain | Beneficial | Moderate |
| Lactobacillus brevis KABP™-052 | Improved Quality of Life | Neutral | Small |
| Lactobacillus brevis KABP™-052 | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis KABP™-052 | Reduced Oral Pain | Beneficial | Moderate |
| Lactobacillus brevis LB01 | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis Lbr-35 | Improved Quality of Life | Neutral | Small |
| Lactobacillus brevis Lbr-35 | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis Lbr-35 | Reduced Oral Pain | Beneficial | Moderate |
| Lactobacillus brevis MAK11L82B | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis MAK11L82B | Reduced Oral Pain | Beneficial | Moderate |
| Lactobacillus brevis SBC8803 | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis SBC8803 | Reduced Oral Pain | Beneficial | Moderate |
| Lactobacillus brevis UALbr-02 | Reduced Duration of Traumatic Oral Lesions | Beneficial | Moderate |
| Lactobacillus brevis UALbr-02 | Reduced Oral Health-Related Quality of Life | Neutral | Small |
| Lactobacillus brevis UALbr-02 | Reduced Oral Pain | Beneficial | Moderate |