Burning Mouth Syndrome (BMS)—Treatment with Verbal and Written Information, B Vitamins, Probiotics, and Low-Level Laser Therapy: A Randomized Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Eligibility Criteria
2.2. Study Setting
2.3. Interventions
2.4. Primary Outcome Measure
2.5. Secondary Outcome Measures
2.6. Sample Size Determination
2.7. Allocation
2.8. Blinding
2.9. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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Type of the Treatment | Informative Conversation and Translated and Adapted Leaflet (Facial Pain Team Based at the Royal National ENT and Eastman Dental Hospitals) | Neurobion Injections (100 mg of Vitamin B1 and B6 and 1 mg of Vitamin B12) | Oral Probiotics (BioGaiaProdentis, BioGaia AB, Stockholm, Sweden) One Lozenge Contains the Patented Lactic Acid Bacterium Lactobacillus reuteri Pro-Dentis® (L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289) | LLLT (Aluminium Gallium Arsenide Laser; Ga–Al–As Diode Type of Laser) |
---|---|---|---|---|
Application mode | At the first appointment. | Total of nine vitamin B injections every other day into the gluteal muscle (i.m.), for three weeks, excluding weekends. | One lozenge to melt in the mouth every evening after flossing and toothbrushing for one month. | Applied on three reported burning sites, with a total of 10 treatments once a day for 10 consecutive days, excluding weekends. |
Parameter | Value |
---|---|
Wavelength (nm) | 685 |
Dose (J/cm2) | 2.0 |
Power (mW) | 30 |
Power density (W/cm2) | 0.003 |
Single treatment duration (s) | 381 |
Distance (cm) | 0.5 |
Treated surface area (cm2) | 3 |
Frequency (Hz) | 50 |
Cumulative dose (J/cm2) | 60 |
Number of treatments | 10 |
Treatment | Age (Median, Range) (Years) | Sex (F = Female, M = Male) |
---|---|---|
Informative | 55 (38–83) | 10 F, 3 M |
B vitamins | 62 (39–60) | 13 F, 4 M |
Oral probiotics | 67 (43–84) | 13 F, 4 M |
LLLT | 60 (44–83) | 11 F, 4 M |
p | >0.05 | >0.05 |
Intergroup Comparison (OHIP) | z-Score | p-Value |
---|---|---|
Informative: B vitamins | −0.23 | 0.409 |
Informative: probiotics | 0.502 | 0.617 |
Informative: LLLT | −0.102 | 0.92 |
B vitamins: probiotics | −1.016 | 0.307 |
B vitamins: LLLT | −0.669 | 0.502 |
Probiotics: LLLT | 0.314 | 0.756 |
Intergroup Comparison (VAS) | z-Score | p-Value |
---|---|---|
Informative: B vitamins | 0.146 | 0.88 |
Informative: probiotics | 0.921 | 0.357 |
Informative: LLLT | 0 | 1 |
B vitamins: probiotics | −0.499 | 0.617 |
B vitamins: LLLT | 0.460 | 0.645 |
Probiotics: LLLT | 1.001 | 0.317 |
Informative | B Vitamins | Oral Probiotics | LLLT | |
---|---|---|---|---|
OHIP-1, median (range) | 13 (3–24) | 24 (0–48) | 22 (2–50) | 20 (4–35) |
OHIP-2, median (range) | 11 (0–24) | 16 (0–51) | 12 (0–46) | 14 (2–31) |
N | 13 | 17 | 17 | 15 |
p | 0.12 | 0.42 | 0.003 | 0.006 |
Standardized effect size | 0.45 | 0.17 | 0.62 | 0.58 |
Informative | B Vitamins | Oral Probiotics | LLLT | |
---|---|---|---|---|
VAS-1, median (range) | 5 (3–7) | 7 (3–10) | 6 (2–10) | 6 (4–9) |
VAS-2, median (range) | 3 (0–6.5) | 4 (0–10) | 5 (0–7) | 5 (3–7) |
N | 13 | 17 | 17 | 15 |
P | 0.001 | 0.003 | 0.004 | 0.004 |
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Lončar-Brzak, B.; Škrinjar, I.; Brailo, V.; Vidović-Juras, D.; Šumilin, L.; Andabak-Rogulj, A. Burning Mouth Syndrome (BMS)—Treatment with Verbal and Written Information, B Vitamins, Probiotics, and Low-Level Laser Therapy: A Randomized Clinical Trial. Dent. J. 2022, 10, 44. https://doi.org/10.3390/dj10030044
Lončar-Brzak B, Škrinjar I, Brailo V, Vidović-Juras D, Šumilin L, Andabak-Rogulj A. Burning Mouth Syndrome (BMS)—Treatment with Verbal and Written Information, B Vitamins, Probiotics, and Low-Level Laser Therapy: A Randomized Clinical Trial. Dentistry Journal. 2022; 10(3):44. https://doi.org/10.3390/dj10030044
Chicago/Turabian StyleLončar-Brzak, Božana, Ivana Škrinjar, Vlaho Brailo, Danica Vidović-Juras, Lada Šumilin, and Ana Andabak-Rogulj. 2022. "Burning Mouth Syndrome (BMS)—Treatment with Verbal and Written Information, B Vitamins, Probiotics, and Low-Level Laser Therapy: A Randomized Clinical Trial" Dentistry Journal 10, no. 3: 44. https://doi.org/10.3390/dj10030044
APA StyleLončar-Brzak, B., Škrinjar, I., Brailo, V., Vidović-Juras, D., Šumilin, L., & Andabak-Rogulj, A. (2022). Burning Mouth Syndrome (BMS)—Treatment with Verbal and Written Information, B Vitamins, Probiotics, and Low-Level Laser Therapy: A Randomized Clinical Trial. Dentistry Journal, 10(3), 44. https://doi.org/10.3390/dj10030044