Introduction
Materials and methods
Protocol and registration
Literature search and selection criteria
Parameter | Inclusion criteria | Exclusion criteria |
---|---|---|
Population | Patients with a diagnosis of BMS according to the International Classification of Headache Disorders-3 (ICHD-3) [29]: patients presenting symptoms of oral burning or pain lasting more than 2 h per day for more than 3 months | Any local or systemic factors that could produce the symptoms of oral burning pain, such as oral infections, oral lichen planus, or oral candidiasis |
Intervention | LLLT (600–1100 nm) was delivered directly to the site of pain; no limitations were placed on exposure duration or distance | |
Comparator | No treatment or other treatments | |
Outcomes | Primary outcome: 1) Burning pain, measured using the Visual Analog Scale (VAS) Secondary outcomes: 1) Oral health-related quality of life, assessed by the Oral Health Impact Profile-14 (OHIP-14); 2) Negative emotions, measured using the Hospital Anxiety and Depression Scale (HADS); 3) Other relevant outcomes and serious adverse events | |
Study design | 1) Randomized controlled trials; 2) Published in English | 1) Observational studies; 2) Non-randomized controlled trials; 3) Other types of studies |
Data extraction and quality assessment
Statistical analysis and data synthesis
Results
Study identification and selection
Description of the included studies
Author (year) | Study design | Country | Participants (% women) | Average age (year, Mean ± SD) (range) | Average disease duration (month, Mean ± SD) (range) | Most common site (%) | Outcome measures and overall results (positive + /negative-) | Serious adverse events | Dropout rate | Time points | |
---|---|---|---|---|---|---|---|---|---|---|---|
1 | Pezelj-Ribaric et al., 2013 [36] | Randomized controlled trial | Croatia | (1) LG: 20; (2) CG: 20 (67.5%) | (1) LG: 60.2 ± 6.3; (2) CG: 61.1 ± 2.2 | Not mentioned | Tongue | (1) TNF-α and IL-6 + (2) Pain/burning (VAS) + | Not mentioned | 0% | Baseline 4 weeks |
2 | Spanemberg et al., 2015 [37] | Randomized controlled trial | Spain | (1) LG1: 20 (2) LG2: 20 (3) RLG: 19 (4) CG: 19 (85.9%) | 62.82 ± 7.54 (45–79) | 6 or above (up to 30 years) | Tongue (up to 90%) Lips (up to 50%) Palate (up to 42.1%) Other sides (up to 20%) | (1) Pain/burning (VAS/VNS) + (2) Oral health-related quality of life (OHIP-14) + | None | 0% | Baseline 10 weeks 8-week follow-up |
3 | Arbabi-Kalati et al., 2015 [26] | Randomized controlled trial | Iran | LG: 10 CG: 10 (100%) | (1) LG: 47.2 ± 5.3 (2) CG: 46.6 ± 4.6 | (1) LG: 13.4 ± 7.4 (6–30) (2) CG: 15.5 ± 0.1 (6–36) | Not mentioned | (1) Pain/burning (NRS) + (2) Oral health-related quality of life (OHIP-14) + | None | 0% | Baseline 2 weeks |
4 | Sugaya et al., 2016 [38] | Randomized controlled trial | Brazil | (1) LG: 15 (2) CG: 15 (91.3%) | (1) LG: 59.3 (29–83) (2) CG: 62.7 (53–81) | (1) 25.5 (6–192) (2) 39.6 (6–180) | Tongue Lower lip Upper lip Buccal mucosa Mandibular ridge Palate Mandibular gingiva | Pain/burning (VAS) + | None | 23.33% | Baseline 2 weeks 7, 14, 30, 60, and 90-day follow-ups |
5 | Valenzuela et al., 2016 [25] | Randomized controlled trial | Spain | (1) LG: 16 (2) LG inf: 16 (3) CG: 12 (93.2%) | 65.5 ± 10.6 (33–88) | 6 or above | Not mentioned | (1) Pain/burning (VAS) + (2) Oral health-related quality of life (OHIP-14) + (3) Xerostomia severity (Xerostomia Inventory) - (1) Anxiety and depression (HADS) - (2) Overall patient satisfaction (PGI-I) - | Not mentioned | 0% | Baseline 4 weeks |
6 | Arduino et al., 2016 [22] | Randomized controlled trial | Italy | (1) LG: 18 (2) CG: 15 (75.8%) | 67.12 ± 8.58 | 6 or above | Not mentioned | (1) Pain/burning (VAS + /McGill + /PPI +) (2) Oral health-related quality of life (OHIP-14) + (3) Salivary flow - (4) Anxiety and depression (HADS) + , (GDS) + | None | 0% | Baseline 5 weeks 3, 8, and 12-month follow-ups |
7 | Sikora et al., 2018 [24] | Randomized controlled trial | Croatia | (1) LG: 22 (2) CG: 22 (97.7%) | 67.56 (56–83) | Not mentioned | Not mentioned | (1) Oral health-related quality of life (OHIP-14) + (2) Pain/burning (VAS) + | Not mentioned | 0% | Baseline 2 weeks |
8 | Spanemberg et al., 2019 [39] | Randomized controlled trial | Spain | (1) LG: 12 (1) CG: 9 (95.2%) | (1) LG: 66.3 ± 7.52 (2) CG: 66.2 ± 6.31 (61–81) | 57.8 (8–130) | Tongue (61.9%) Lips (52.4%) Palate (42.9%) Other sides (28.6%) | (1) Pain/burning (VAS) + (1) Anxiety and depression (HADS) - | None | 0% | Baseline 8 weeks 2-month follow-up |
9 | Bardellini et al., 2019 [40] | Randomized controlled trial | Italy | (1) LG: 45 (2) CG: 45 (100%) | (1) LG: 59.76 ± 9.51 (39–74) (2) CG: 60.86 ± 10.02 (41–77) | 6 or above | Tongue (76.5%) Lips (18.8%) Buccal mucosa (44.7%) Other sides (9.4%) | (1) Pain/burning (VAS) + (2) Oral health-related quality of life (OHIP-14) + | Not mentioned | 5.6% | Baseline 10 weeks 1-month follow-up |
10 | de Pedro et al., 2020 [20] | Randomized controlled trial | Spain | (1) LG: 10 (2) CG: 10 (80%) | (1) LG: 60.30 ± 15.19 (2) CG: 67.60 ± 10.68 | Not mentioned | Tongue (100%) Buccal mucosa (45%) Lips (30%) Hard palate (10%) | (1) Pain/burning (VAS/McGill) + (2) Oral health-related quality of life (OHIP-14) + (3) General health status (SF-36) + (4) Drowsiness/sleepiness (ESS) + (5) Anxiety and depression (SCL 90-R) + | None | 0% | Baseline 5 weeks 1 and 4-month follow-ups |
11 | Skrinjar et al., 2020 [23] | Randomized controlled trial | Croatia | (1) LG: 12 (2) CG: 11 (86.9%) | (1) LG: 61.5 (47–70) (2) CG: 62 (50–69) | 3 or above | Tongue Lip Hard palate | (1) Pain/burning (VAS) + (2) Salivary cortisol level + | None | 0% | Baseline 2 weeks |
12 | Barbosa et al., 2020 [27] | Randomized controlled trial | Brazil | (1) LG: 10 (2) CG: 5 (60%) | 45 (40–52) | 12 (4–24) | Tongue (66.7%) Lips (26.7%) Palate (20%) Cheek mucosa (20%) Alveolar ridge (13.3%) | (1) Salivary flow + (2) TNF-α - (3) Pain/burning (VAS) + | None | 0% | Baseline 4 weeks |
13 | Scardina et al., 2020 [41] | Randomized controlled trial | Italy | (1) LG: 20; (2) CG: 20 (100%) | 62.06 ± 3.1 | Not mentioned | Upper labial mucosa; Buccal mucosa Dorsal lingual surface Lower labial mucosa | (1) Pain/burning (VAS/NRS) + (2) Capillary microcirculation (Oral videocapillaroscopy examination) + | None | 0% | Baseline 4 weeks 2-month follow-up |
14 | Sun et al., 2021 [12] | Randomized controlled trial | China | (1) LG: 21 (2) CG: 21 (80.9%) | (1) LG: 56.19 (2) CG: 47 (19–71) | (1) LG: 11.8 (2) CG: 7.00 (2–60) | Tongue (100%) | (1) Pain/burning (VAS) + (2) Numbness (VAS) + (3) Alter taste (VAS) - | None | 0% | Baseline 4 weeks |
Author (year) | Physical therapy in the intervention group | Control group intervention | Frequency | Time points | |
---|---|---|---|---|---|
1 | Pezelj-Ribaric et al., 2013 [36] | GaAlAs, 685 nm, 30 mW, 3.0 J/cm2, 100 s/point, irradiation area: 1 cm2, tip diameter: 2 mm | Inactive/placebo laser: the same time and the same points, but without power | 5 times per week | Baseline 4 weeks |
2 | Spanemberg et al., 2015 [37] | (1) LG1: GaAlAs, 830 nm, 100 mW, 5 J/point, 176 J/cm2, 3.57 W/cm2, 50 s/point (2) LG2: GaAlAs, 830 nm, 100 mW, 5 J/point, 176 J/cm2, 3.57 W/cm2, 50 s/point (3) RLG: 685 nm, 35 mW, 2 J/point, 72 J/cm2, 1.25 W/cm2, 58 s/point | Sham LLLT: searching for similarities to the IR3 W and red laser groups; however, the tool received a plastic tip with a rubber interior that blocked radiation emission | (1) LG1: once per week (2) LG2: 3 times per week (3) RLG: 3 times per week (4) CG: 3 times per week | Baseline 10 weeks 8-week follow-up |
3 | Arbabi-Kalati et al., 2015 [26] | GaAlAs, 630 nm, 30 mW, 1 J/cm2, 10 s/point. Laser application points: 10 areas on the oral mucosa, 2 areas on the buccal mucosa on each side, 2 areas on the tongue, 2 areas on the floor of the mouth, 1 area on the soft palate, and 1 area on the hard palate | Inactive/placebo laser: the same period, the same areas but the laser was silent | twice per week | Baseline 2 weeks |
4 | Sugaya et al., 2016 [38] | GaAlAs, 790 nm, 120 mW, 4 W/cm2, 6 J/cm2, 50 s/point, irradiation area: 0.03 cm2 | Inactive/placebo laser: the same procedures but the device turned off | twice per week | Baseline 2 weeks 7, 14, 30, 60, and 90-day follow-ups |
5 | Valenzuela et al., 2016 [25] | (1) LG: GaAlAs, 815 nm, 1 W, 4 s/point, 133.3 J/cm2; irradiation area: 0.03 cm2 (2) LG inf: GaAlAs, 815 nm inf, 1 W, 6 s/point, 200 J/cm2 irradiation area: 0.03 cm2 | Sham LLLT: the same procedure but the laser turned off | once per week | Baseline 4 weeks |
6 | Arduino et al., 2016 [22] | GaAlAs, 980 nm, 300 mW, 1 W/cm2, 10 J/cm2, 10 s/point, irradiation distance: 2 mm, area: 0.28 cm2, tip diameter: 6 mm. All the mucosal burning sites were irradiated | Clonazepam: suck half a tablet of 2 mg of clonazepam and hold their saliva near the pain sites in the mouth without swallowing for 3 min and then spit. This protocol has to be repeated three times a day for 21 days | 5 times per week | Baseline 5 weeks 3, 8, and 12-month follow-ups |
7 | Sikora et al., 2018 [24] | GaAlAs, 830 nm, 100 mW, 12 J/cm2, irradiation distance: 5 mm, area: 1 cm2; switched on: 800 ms, switched off: 1 ms. Laser application points: the site in the mouth where burning symptoms | Sham laser: LLLT switched off | 5 times per week | Baseline 2 weeks |
8 | Spanemberg et al., 2019 [39] | GaAlAs, 808 ± 5 nm, 200 mW, 1.97 W/cm2, 3 J/point, 15 s/point, irradiation area: 0.088 cm2. Laser application points: the tip of the tongue: 3 points; lateral border of the tongue: 4 points; dorsal surface of the tongue: 10 points; buccal mucosa: 8 points; labial mucosa: 5 points, hard palate: 8 points, soft palate: 3 points; gingiva or alveolar mucosa: 3 points by sextant | Inactive/placebo laser: the same protocol but the laser was deactivated. Neither the patient nor the researcher knew if the laser was activated or not | once per 2 weeks | Baseline 8 weeks 2-month follow-up |
9 | Bardellini et al., 2019 [40] | K laser Cube 3, 660–970 nm, 3.2 W, 1–20 000 Hz, irradiation area: 1 cm2. The most painful areas in the oral cavity were irradiated | Inactive/placebo laser: the device was turned on but the handpiece did not work | once per week | Baseline 10 weeks 1-month follow-up |
10 | de Pedro et al., 2020 [20] | Diode Laser Fox, 810 nm, 0.6 W, 1.2 W/cm2, 6 J, 12 J/cm2, 10 s/point, irradiation area: 0.5 cm2. Laser application points: 56 points (3 in the vestibular mucosa of the 4 quadrants, 4 in each lip mucosa, 6 in each of the two buccal mucosae, 6 in the hard palate, 4 on each lateral edge of the tongue, 6 in the dorsum of the tongue and 4 sublingual points) with a distance in between of 2 mm | Inactive/placebo laser: the same 56 points, 10 s per point, and the same number of sessions but the device turned off | twice per week | Baseline 5 weeks 1 and 4-month follow-ups |
11 | Skrinjar et al., 2020 [23] | GaAlAs, 685 nm, 30 mW, 0.003 W/cm2, cumulative dose: 60 J/cm2; dose: 2 J/cm2, 5.20 Hz; irradiation distance: 5 mm, area: 3 cm2 | Inactive/placebo laser: the same treatment protocol but LLLT was done with an inactive laser probe which was only emitting the audio signal | 5 times per week | Baseline 2 weeks |
12 | Barbosa et al., 2020 [27] | Visible low-level class 3B laser, 660 nm, 30 mW, 3 J/cm2, 10 s/point, irradiation distance: 10 mm, tip diameter: 3 mm | ALA: treated for 30 days with 600 mg ALA (3 tablets of 200 mg per day after meals) and 150 mg ranitidine for gastric protection (one tablet in the morning) | once per day | Baseline 4 weeks |
13 | Scardina et al., 2020 [41] | BioLase Epic10, 805 nm, 4 W power, 60 mW continuous wave, 1200 J, 50 J/cm2, 166.7 mW/cm2, 300 s, irradiation distance: 40 mm. Laser application points: the upper labial mucosa, buccal mucosa, dorsal lingual surface, and lower labial mucosa | Inactive/placebo laser: the same sessions, the only difference was the non-emission of the laser | twice per week | Baseline 4 weeks 2-month follow-up |
14 | Sun et al., 2021 [12] | Nd: YAG laser, 1064 nm; 100 mW, 3 J/cm2, 10 Hz, 30 s/point; irradiation distance: 6 mm, area: 1 cm2. Laser application points: the tongue was divided into 17 treatment regions and only areas of the tongue reported as symptomatic were irradiated | Inactive/placebo laser: instrument switched off | once per week | Baseline 4 weeks |