Efficacy of 660 nm Photobiomodulation in Burning Mouth Syndrome Management: A Single-Blind Quasi-Experimental Controlled Clinical Trial.

Background: Burning mouth syndrome (BMS) is characterized by a burning sensation of the oral mucosa without any evidence of clinical signs or underlining condition. Several treatment modalities have been utilized with various results and levels of evidence. Lately, photobiomodulation (PBM) has emerged as a noninvasive effective therapy due to its anti-inflammatory and biostimulatory effects, especially the low-power laser setting of red wavelength. Objective: This single-blind quasi-experimental controlled clinical trial aimed to evaluate the PBM effectiveness at a low level of red laser light in patients with BMS compared with sham control. Materials and methods: Thirty patients diagnosed with BMS were consecutively assigned to intervention (PBM therapy) and control (sham) groups. The protocol for PBM dosimetry was as follows: laser 660 nm; spot size: 0.04 cm2; power output: 100 mW; emission mode: continuous wave; power density: 6 J/cm2; irradiation time: 10 sec per point within 1 cm2 surface area of the symptomatic area. The treatment protocol was based on once a week for a total of 10 sessions. Results: Our results showed no statistically significant difference in reduction of pain intensity between the two groups at all the evaluated timepoints during the course of treatment. However, in both groups, we observed a statistically significant reduction of maximum pain intensity of 50% compared with patient-self reporting before the treatment. Conclusions: Further randomized clinical trials to validate our positive results with a large sample size with a long-term follow-up and understanding further the sham placebo effect are warranted.

Effects of low-level laser therapy on burning pain and quality of life in patients with burning mouth syndrome: a systematic review and meta-analysis.

BACKGROUND: Burning mouth syndrome (BMS) is a complex chronic pain disorder that significantly impairs patients' quality of life. Low-level laser therapy (LLLT) uses infrared or near-infrared light to produce analgesic, anti-inflammatory, and biological stimulation effects. The aim of this systematic review is to evaluate the effect of LLLT on burning pain, quality of life, and negative emotions in patients with BMS. METHODS: The PubMed, Embase, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Cochrane Library, Web of Science, and Scopus databases were searched up January 2023 to identify relevant articles. All randomized controlled trials that were published in English and examined the use of LLLT treatment for BMS were included. The methodological quality of the included trials was assessed using the Cochrane risk of bias tool for randomized controlled trials (RCTs). A meta-analysis was performed to evaluate burning pain, quality of life, and negative emotions. Sensitivity, subgroup, and funnel plot analyses were also carried out. RESULTS: Fourteen RCTs involving a total of 550 patients with BMS met the inclusion criteria. The results showed that LLLT (measured by the Visual Analog Scale; SMD: -0.87, 95% CI: -1.29 to -0.45, P < 0.001) was more effective for reducing burning pain than placebo LLLT or clonazepam. LLLT improved quality of life (evaluated by the Oral Health Impact Profile-14; SMD: 0.01, 95% CI: -0.58 to 0.60, P = 0.97) and negative emotions (evaluated by the Hospital Anxiety and Depression Scale; SMD: -0.12, 95% CI: -0.54 to 0.30, P = 0.59), but these effects were not statistically significant. CONCLUSIONS: The meta-analysis revealed that LLLT may be an effective therapy for improving burning pain in patients with BMS, and producing a positive influence on quality of life and negative emotions. A long-term course of intervention, a larger sample size, and a multidisciplinary intervention design are urgently needed in future research. TRIAL REGISTRATION: PROSPERO registration number: CRD42022308770.

Efficacy of photobiomodulation in reducing pain and improving the quality of life in patients with idiopathic burning mouth syndrome. A systematic review and meta-analysis.

Burning mouth syndrome is a chronic condition, which is characterised by a burning sensation or pain in the mucosa of the oral cavity. Treatment options include antidepressants, antipsychotics, anticonvulsants, analgesics, hormone replacement therapies and more recently photobiomodulation. This study aims to perform a systematic review with meta-analysis in order to determine the effect of photobiomodulation on pain relief and the oral health-related quality of life associated with this condition. A bibliographical search of the Pubmed, Embase, Web of Science and Scopus databases was conducted. Only randomised clinical trials were included. Pain and quality of life were calculated as mean difference and pooled at different treatment points (baseline = T0 and final time point = Tf) and laser modality. From a total of 103 records, 7 articles were retrieved for inclusion. PBM group had a greater decrease in pain than control group at Tf with a mean difference = - 2.536 (IC 95% - 3.662 to - 1.410; I2 = 85.33%, p < 0.001). An improvement in oral health-related quality of life was observed in both groups, although this was more significant in the photobiomodulation group mean difference = - 5.148 (IC 95% - 8.576 to - 1.719; I2 = 84.91%, p = 0.003). For the red laser, a greater improvement than infrared was observed, in pain, mean difference = - 2.498 (IC 95% - 3.942 to - 1.053; I2 = 79.93%, p < 0.001), and in quality of life, mean difference = - 8.144 (IC 95% - 12.082 to - 4.206; I2 = 64.22%, p = 0.027). Photobiomodulation, in particular, red laser protocols, resulted in improvement in pain and in quality of life of burning mouth syndrome patients.

Effectiveness of photobiomodulation in the treatment of primary burning mouth syndrome-a systematic review and meta-analysis.

To evaluate the effectiveness of photobiomodulation (PBM) on primary burning mouth syndrome (pBMS). We searched Chinese and English studies published before February 10, 2020. The databases used include PubMed, EMBASE, the Cochrane Library, Web of Science, Wanfang Database, and China National Knowledge Infrastructure (CNKI). Randomized controlled clinical trials (RCTs) that used the PBM to treat pBMS and reported specific treatment outcomes were considered for inclusion. We eventually included 12 RCTs, and 574 samples were included in these studies. The primary outcomes investigated were pain reduction and life quality improvement. A meta-analysis performed on 9 groups in 5 trials showed that PBM was effective in reducing pain compared with placebo (MD - 1.86, 95% CI - 2.59 to - 1.13, Z = 4.99, P < 0.00001). Meta-analysis was also performed on 7 groups in 4 trials and showed that PBM was effective in improving life quality compared with placebo (MD - 3.43, 95% CI - 5.11 to - 1.75, Z = 4.00, P < 0.0001). Qualitative analysis of the included RCTs found that PBM might also play a role in the decrease of TNF-α and IL-6 in saliva. Three studies that compared PBM with medications were evaluated by descriptive analysis. None of the treatment-related adverse event was reported. Up to date, PBM appears to have an effect on pain reduction and life quality improvement in pBMS patients. However, more evidence is still required to warrant its efficacy and safety in treating pBMS.

Evaluation of laser therapy and alpha-lipoic acid for the treatment of burning mouth syndrome: a randomized clinical trial.

The aim of this study was to evaluate the efficacy of low-level laser therapy (LLLT) and alpha-lipoic acid (ALA) in the treatment of burning mouth syndrome (BMS) and secondary oral burning (SOB) by unstimulated sialometry, symptom assessment, and measurement of salivary TNF-α levels. Forty-four patients were randomized into four treatment groups: BMS/laser (n = 10), BMS/ALA (n = 5), SOB/laser (n = 15), and SOB/ALA (n = 14). The control group consisted of eight healthy female subjects. Unstimulated salivary flow was measured before and after treatment, and the collected saliva was stored at - 20 °C for the analysis of TNF-α. Symptoms were evaluated before and after treatment using a pain visual analog scale. Most patients were women (81.8%) during menopause (72.2%). LLLT and ALA were efficient in increasing salivary flow only in BMS but provided symptom relief in both conditions. TNF-α levels did not differ between patients with BMS and SOB or between those patients and the control group. No differences were observed in posttreatment TNF-α levels in either condition. The results of this study suggest that LLLT and ALA are efficient therapies in reducing burning mouth symptoms, with LLLT being more efficient than ALA.

Efficacy of low level laser therapy in the treatment of burning mouth syndrome: A systematic review.

BACKGROUND: Burning mouth syndrome (BMS) is a chronic pain condition with indefinite cure, predominantly affecting post-menopausal women. The aim of this study was to systematically review the efficacy of low level laser therapy in the treatment of burning mouth syndrome (BMS). METHODS: PubMed, Embase and Scopus were searched from date of inception till and including October 2016 using various combinations of the following keywords: burning mouth syndrome, BMS, stomatodynia, laser therapy, laser treatment and phototherapy. The inclusion criteria were: Prospective, retrospective and case series studies. Letter to editors, reviews, experimental studies, studies that were not published in English, theses, monographs, and abstracts presented in scientific events were excluded. Due to heterogeneity of data no statistical analyses were performed. RESULTS: Ten clinical studies fulfilled the eligibility criteria, five of which were randomized clinical trials. In these studies, the laser wavelengths, power output and duration of irradiation ranged between 630-980nm, 20-300mW, 10s-15min, respectively. Most of studies reported laser to be an effective therapy strategy for management of BMS. CONCLUSION: Majority of the studies showed that laser therapy seemed to be effective in reducing pain in BMS patients. However, due to the varied methodologies and substantial variations in laser parameters among these studies, more clinical trials are required to ascertain the efficacy of laser for treating BMS.

Effects of low-level laser therapy on burning mouth syndrome.

To investigate low-level laser therapy (LLLT) applied to treat burning mouth syndrome (BMS). This prospective, comparative, partially blinded, single-centre, clinical trial of GaAlAs Laser, with 815 nm wavelength, included 44 BMS patients divided randomly into three groups: Group I (n = 16): GaAlAs laser 815 nm wavelength, 1 W output power, continuous emissions, 4 s, 4 J and fluence rate 133·3 J cm-2 ; Group II (n = 16): GaAlAs infrared laser, 815 nm wavelength, 1 W output power, continuous emissions, 6 s, 6 J and fluence rate 200 J cm-2 ; Group III (n = 12) placebo group, sham laser. All groups received a weekly dose for 4 weeks. Pain intensity was recorded using a 10-cm visual analogue scale; patients responded to the oral health impact profile (OHIP-14), xerostomia severity test and the hospital anxiety-depression scale (HAD). These assessments were performed at baseline, 2 and 4 weeks. LLLT decreased pain intensity and improved OHIP-14 scores significantly from baseline to 2 weeks in groups I and II compared with the placebo group. No statistically significant differences were found from 2 to 4 weeks. Overall improvements in visual analogue scale (VAS) scores from baseline to the end of treatment were as follows: Group I 15·7%; Group II 15·6%; Group III placebo 7·3%. LLLT application reduces symptoms slightly in BMS patients.

Low-level Laser Therapy: A Review of Its Applications in the Management of Oral Mucosal Disorders.

Due to its analgesic, anti-inflammatory, and biostimulating effects, low-level laser therapy (LLLT) has been widely used for oral disorders, such as oral lichen planus (OLP), xerostomia, recurrent aphthous stomatitis (RAS), herpes labialis, burning mouth syndrome (BMS), and oral mucositis (OM). The research team for the present study has reviewed the literature on the subject, with an emphasis on the applicability of LLLT in general and of its various clinical protocols for the management of those oral disorders. In lesions such as the ones occurring in OM, RAS, herpes labialis, and OLP, the course of wound healing and the pain have been shown to decrease, with a few, or most often, no adverse side effects. The literature shows that LLLT can also be effective in reducing symptoms in patients with BMS. For the treatment of hyposalivation and xerostomia, the use of LLLT has been described in the literature, but no consensus has resulted. Very few controlled clinical studies with well-established therapeutic protocols have occurred, except for OM, for which LLLT has been widely researched. Although information on the use of the laser for some lesions has already been consolidated, further research is needed, especially randomized, controlled clinical trials with long-term follow-up. Those studies will allow the safe use of LLLT, permitting the creation of care protocols for the management of oral disorders.

Low Intensity laser therapy in patients with burning mouth syndrome: a randomized, placebo-controlled study.

The aim of this study was to assess the effectiveness of low intensity laser therapy in patients with Burning Mouth Syndrome (BMS). Thirty BMS subjects were randomized into two groups - Laser (LG) and Placebo (CG). Seven patients dropped out, leaving 13 patients in LG and 10 patients in CG. Each patient received 4 irradiations (laser or placebo) twice a week, for two consecutive weeks (blinded to the type of irradiation received). Infrared laser (AsGaAI) irradiations were applied to the affected mucosa in scanning mode, wavelength of 790 nm, output power of 20 mW and fluence of 6 J/cm2. A visual analogue scale (VAS) was used to assess the therapeutic effect before and after each irradiation, and at all the control time periods: 7, 14, 30, 60 and 90 days after the last irradiation. One researcher delivered irradiation and another recorded the results. Both researchers were blinded, the first to the results, and the second to the type of radiation applied. The results were categorized according to the percentage of symptom level variation, and showed a statistically better response in LG in only two categories of the control checkpoints (p=0.02; Fisher's Exact Test). According to the protocol used in this study, low intensity laser therapy is as beneficial to patients with BMS as placebo treatment, indicating a great emotional component of involvement in BMS symptomatology. Nevertheless, there were positive results in some statistical analyses, thus encouraging further research in BMS laser therapy with other irradiation parameters.

A randomized pilot study to assess the safety and the value of low-level laser therapy versus clonazepam in patients with burning mouth syndrome.

Comparison between low-level laser therapy (LLLT) and clonazepam for treating burning mouth syndrome (BMS) patients has never been documented; the aim of this study was to assess the effects of LLLT photobiomodulation versus medical therapy with clonazepam on BMS. Thirty-three patients (25 female, 8 male, mean age = 67.12) were randomly allocated to two different groups: the first one (group A, 18 patients) underwent two laser irradiation sessions weekly for 5 weeks, whereas the second one (group B, 15 patients) received topical clonazepam therapy [half a tablet (2 mg) in the mouth without swallowing for 3 min, three times a day for 21 days]. LLLT was delivered with a continuous wave 980-nm aluminum gallium arsenide (AlGaAs) diode laser and the output of 300 mW, delivering a Fluence of 10 J/cm(2), using a "spot technique," with an average power density of about 1 W/cm(2). The laser probe was held perpendicularly at a distance of about 2 mm from the mucosa. Visual analogue scale (VAS), McGill Pain Questionnaire, present pain intensity (PPI), and Oral Health Impact Profile (OHIP-49) assessed sensation of pain. Hospital Anxiety and Depression Scale and Geriatric Depression Scale assessed levels of anxiety and depression. Twelve weeks after the end of treatment, patients treated with LLLT experienced a decrease in pain sensation reported for all the parameters analyzed: VAS (P = 0.004), McGill Pain Questionnaire (P = 0.002), PPI (P = 0.002), and OHIP-49 (P = 0.010). The group treated with clonazepam had less favorable results for VAS (P = 0.33), McGill Pain Questionnaire (P = 0.005), PPI (P = 0.013), and OHIP-49 (P = 0.25). Levels of anxiety and depression did not change statistically in any groups (P > 0.05). Comparing the two groups, LLLT appeared to be superior in improving pain perception, but statistically only at 8 weeks after the end of the protocol proposed (P = 0.026). Based on this preliminary trial, LLLT is capable of reducing the symptoms of patients with BMS with a constant and long-lasting effect, experienced since the end of the first applications.

Low Intensity laser therapy in patients with burning mouth syndrome: a randomized, placebo-controlled study

Abstract The aim of this study was to assess the effectiveness of low intensity laser therapy in patients with Burning Mouth Syndrome (BMS). Thirty BMS subjects were randomized into two groups - Laser (LG) and Placebo (CG). Seven patients dropped out, leaving 13 patients in LG and 10 patients in CG. Each patient received 4 irradiations (laser or placebo) twice a week, for two consecutive weeks (blinded to the type of irradiation received). Infrared laser (AsGaAI) irradiations were applied to the affected mucosa in scanning mode, wavelength of 790 nm, output power of 20 mW and fluence of 6 J/cm2. A visual analogue scale (VAS) was used to assess the therapeutic effect before and after each irradiation, and at all the control time periods: 7, 14, 30, 60 and 90 days after the last irradiation. One researcher delivered irradiation and another recorded the results. Both researchers were blinded, the first to the results, and the second to the type of radiation applied. The results were categorized according to the percentage of symptom level variation, and showed a statistically better response in LG in only two categories of the control checkpoints (p=0.02; Fisher's Exact Test). According to the protocol used in this study, low intensity laser therapy is as beneficial to patients with BMS as placebo treatment, indicating a great emotional component of involvement in BMS symptomatology. Nevertheless, there were positive results in some statistical analyses, thus encouraging further research in BMS laser therapy with other irradiation parameters.

Proinflammatory cytokine levels in saliva in patients with burning mouth syndrome before and after treatment with low-level laser therapy.

The aim of this study was to determine the levels of proinflammatory tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) cytokines in whole unstimulated saliva in subjects with burning mouth syndrome (BMS) before and after treatment with low-level laser therapy (LLLT). BMS is characterized by a continuous, painful burning sensation in a clinically normal-appearing oral mucosa. A sample consisting of 40 consecutive subjects was selected on a voluntary basis from the pool of patients who presented for diagnosis and treatment of BMS at the Oral Medicine Unit of the Faculty of Medicine of the University of Rijeka. For determination of salivary levels of TNF-α and IL-6, ELISA (Sigma Immunochemicals, St. Louis, MO, USA) was performed to determine the salivary levels of TNF-α and IL-6. After 4 weeks of LLLT, the salivary levels of TNF-α and IL-6 in the experimental group decreased significantly (p < 0.001). There was no significant difference in the experimental group regarding visual analogue scale.

Effect of low-level laser therapy in the treatment of burning mouth syndrome: a case series.

OBJECTIVE: The aim of this study was evaluate the effect of low-level laser therapy (LLLT) in the treatment of burning mouth syndrome (BMS) patients. BACKGROUND DATA: BMS is a clinical condition characterized by a burning sensation in a morphologically normal oral mucosa, without association with systemic disorders. METHODS: Ten patients with oral burning sensation were included in the study. After careful evaluation of medical history and oral examination, the diagnosis of BMS was established. All patients were submitted to one weekly session of LLLT for 10 weeks. A continuous wavelength of 660 nm, power 40 mW, 20 J/cm(2), 0.8 J/point, with each point irradiated for 10 sec. In all sessions the burning intensity was evaluated with a 10-cm visual analogue scale (VAS), with 0 indicating no symptoms and 10 indicating the worst burning possible. The burning intensity evaluation by VAS was performed immediately before (VAS baseline) and immediately after each LLLT session. The nonparametric Wilcoxon test was used for statistical analysis, considering significance of 5%. RESULTS: All patients reported improvement in all sessions, with reduction in VAS scores by up to 58% in the tenth session. When only the VAS baseline of the first session was compared with the other sessions, there was a statistically significant reduction in VAS scores in the fourth (p=0.03), fifth (p=0.03), sixth (p=0.009), seventh (p=0.003), eighth, ninth, and tenth (all p=0.002) sessions. CONCLUSIONS: LLLT may be an alternative treatment for the relief of oral burning in patients with BMS.

Treatment of burning mouth syndrome with a low-level energy diode laser.

OBJECTIVE: To test the therapeutic efficacy of low-level energy diode laser on burning mouth syndrome. BACKGROUND: Burning mouth syndrome is characterized by burning and painful sensations in the mouth, especially the tongue, in the absence of significant mucosal abnormalities. Although burning mouth syndrome is relatively common, little is known regarding its etiology and pathophysiology. As a result, no treatment is effective in all patients. Low-level energy diode laser therapy has been used in a variety of chronic and acute pain conditions, including neck, back and myofascial pain, degenerative osteoarthritis, and headache. METHODS: A total of 17 patients who had been diagnosed with burning mouth syndrome were treated with an 800-nm wavelength diode laser. A straight handpiece was used with an end of 1-cm diameter with the fiber end standing 4 cm away from the end of handpiece. When the laser was applied, the handpiece directly contacted or was immediately above the symptomatic lingual surface. The output used was 3 W, 50 msec intermittent pulsing, and a frequency of 10 Hz, which was equivalent to an average power of 1.5 W/cm(2) (3 W × 0.05 msec × 10 Hz = 1.5 W/cm(2)). Depending on the involved area, laser was applied to a 1-cm(2) area for 70 sec until all involved area was covered. Overall pain and discomfort were analyzed with a 10-cm visual analogue scale. RESULTS: All patients received diode laser therapy between one and seven times. The average pain score before the treatment was 6.7 (ranging from 2.9 to 9.8). The results showed an average reduction in pain of 47.6% (ranging from 9.3% to 91.8%). The burning sensation remained unchanged for up to 12 months. CONCLUSION: Low-level energy diode laser may be an effective treatment for burning mouth syndrome.

Low-level laser therapy in burning mouth syndrome patients: a pilot study.

OBJECTIVE: The aim of this study was to investigate the effect of low-level laser therapy (LLLT) on the treatment of burning mouth syndrome (BMS). In addition, the laser effect was compared on the different affected oral sites. MATERIALS AND METHODS: Eleven subjects with a total of 25 sites (tongue, lower lip, upper lip, and palate) affected by a burning sensation were selected. The affected areas were irradiated once a week for three consecutive weeks with an infrared laser (λ = 790 nm). The probe was kept in contact with the tissue, and the mucosal surface was scanned during the irradiation. The exposure time was calculated based on the fluence of 6 J/cm(2), the output power of 120 mW, and the area to be treated. Burning intensity was recorded through a visual analog scale before and after the treatment and at the 6-week follow-up. The percentage of the improvement in symptoms was also obtained. RESULTS: Burning intensity at the end of the laser therapy was statistically lower than at the beginning (p < 0.01). Patients reported an 80.4% reduction in the intensity of symptoms after laser treatment. There was no statistical difference between the end of the treatment and the 6-week follow-up, except for the tongue site. CONCLUSION: Under the investigated parameters, infrared LLLT proved to be a valuable alternative for BMS treatment, providing a significant and lasting reduction in symptoms.