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Abstract：
OBJECTIVE: Burning mouth syndrome (BMS) is a chronic pain disorder characterized by intraoral burning or dysaesthetic sensation, with the absence of any identifiable lesions. Numerous treatments for BMS have been investigated, though without conclusive results. An analysis was conducted of the efficacy of treatment with a low-level diode laser and clonazepam in patients with BMS, and a study was carried out on the levels of different salivary biomarkers before and after treatment.
METHODS: A randomized, single-blind clinical trial was carried out involving 89 patients divided into the following groups: group 1 (laser, The Helbo® Theralite Laser 3D Pocket Probe + clonazepam) (n = 20), group 2 (sham laser placebo) (n = 19), group 3 (laser) (n = 21) and group 4 (clonazepam) (n = 18). Symptom intensity was scored based on a visual analogue scale (VAS). Sialometry was performed before and after treatment, and the Xerostomia Inventory, Oral Health Impact Profile-14 (OHIP-14) and Mini-Nutritional Assessment (MNA) questionnaires were administered. The following markers were measured in saliva samples: interleukins (IL2, IL4, IL5, IL6, IL7, IL8, IL1β, IL10, IL12, IL13, IL17, IL21 and IL23), proteins (MIP-3α, MIP-1α and MIP-1β), GM-CSF, interferon gamma (IFNγ), interferon-inducible T-cell alpha chemoattractant (ITAC), fractalkine and tumor necrosis factor α (TNFα).
RESULTS: A significant decrease in the VAS scores was observed after treatment in group 1 (laser + clonazepam) (p = 0.029) and group 3 (laser) (p = 0.005). In turn, group 3 (laser) showed a decrease in the salivary concentration of fractalkine (p = 0.025); interleukins IL12 (p = 0.048), IL17 (p = 0.020), IL21 (p = 0.008), IL7 (p = 0.001) and IL8 (p = 0.007); proteins MIP1α (p = 0.048) and MIP1β (p = 0.047); and TNFα (p = 0.047) versus baseline. Following treatment, group 1 (laser + clonazepam) showed significant differences in IL21 (p = 0.045) and IL7 (p = 0.009) versus baseline, while group 4 (clonazepam) showed significant differences in IL13 (p = 0.036), IL2 (p = 0.020) and IL4 (p = 0.001). No significant differences were recorded in group 2 (sham laser placebo).
CONCLUSIONS: The low-level diode laser is a good treatment option in BMS, resulting in a decrease in patient symptoms and in salivary biomarkers. However, standardization of the intervention protocols and laser intensity parameters is needed in order to draw more firm conclusions.
METHODS: A randomized, single-blind clinical trial was carried out involving 89 patients divided into the following groups: group 1 (laser, The Helbo® Theralite Laser 3D Pocket Probe + clonazepam) (n = 20), group 2 (sham laser placebo) (n = 19), group 3 (laser) (n = 21) and group 4 (clonazepam) (n = 18). Symptom intensity was scored based on a visual analogue scale (VAS). Sialometry was performed before and after treatment, and the Xerostomia Inventory, Oral Health Impact Profile-14 (OHIP-14) and Mini-Nutritional Assessment (MNA) questionnaires were administered. The following markers were measured in saliva samples: interleukins (IL2, IL4, IL5, IL6, IL7, IL8, IL1β, IL10, IL12, IL13, IL17, IL21 and IL23), proteins (MIP-3α, MIP-1α and MIP-1β), GM-CSF, interferon gamma (IFNγ), interferon-inducible T-cell alpha chemoattractant (ITAC), fractalkine and tumor necrosis factor α (TNFα).
RESULTS: A significant decrease in the VAS scores was observed after treatment in group 1 (laser + clonazepam) (p = 0.029) and group 3 (laser) (p = 0.005). In turn, group 3 (laser) showed a decrease in the salivary concentration of fractalkine (p = 0.025); interleukins IL12 (p = 0.048), IL17 (p = 0.020), IL21 (p = 0.008), IL7 (p = 0.001) and IL8 (p = 0.007); proteins MIP1α (p = 0.048) and MIP1β (p = 0.047); and TNFα (p = 0.047) versus baseline. Following treatment, group 1 (laser + clonazepam) showed significant differences in IL21 (p = 0.045) and IL7 (p = 0.009) versus baseline, while group 4 (clonazepam) showed significant differences in IL13 (p = 0.036), IL2 (p = 0.020) and IL4 (p = 0.001). No significant differences were recorded in group 2 (sham laser placebo).
CONCLUSIONS: The low-level diode laser is a good treatment option in BMS, resulting in a decrease in patient symptoms and in salivary biomarkers. However, standardization of the intervention protocols and laser intensity parameters is needed in order to draw more firm conclusions.
摘要：
目的：燃烧口综合征（BMS）是一种慢性疼痛障碍，其特征是口腔内灼热或美感障碍，没有任何可识别的病变。已经研究了许多BMS的治疗方法，虽然没有决定性的结果。对BMS患者使用低强度二极管激光和氯硝西泮治疗的疗效进行分析,并对治疗前后不同唾液生物标志物水平进行了研究。
方法：随机，进行了单盲临床试验，涉及89例患者，分为以下组：第1组（激光，Helbo®Theralite激光3D袖珍探头+氯硝西泮（n=20），第2组（假激光安慰剂）（n=19），第3组(激光)(n=21)和第4组(氯硝西泮)(n=18)。根据视觉模拟量表（VAS）对症状强度进行评分。在治疗前和治疗后进行唾液酸测定，和口干症清单，进行了口腔健康影响概况-14（OHIP-14）和迷你营养评估（MNA）问卷。在唾液样品中测量了以下标记：白介素（IL2，IL4，IL5，IL6，IL7，IL8，IL1β，IL10、IL12、IL13、IL17、IL21和IL23)，蛋白质(MIP-3α，MIP-1α和MIP-1β)，GM-CSF,干扰素γ（IFNγ），干扰素诱导的T细胞α化学引诱物（ITAC），Fractalkine和肿瘤坏死因子α（TNFα）。
结果：治疗后，第1组（激光氯硝西泮）（p=0.029）和第3组（激光）（p=0.005）的VAS评分显着降低。反过来,第3组（激光）显示fractalkine的唾液浓度降低（p=0.025）;白细胞介素IL12（p=0.048），IL17（p=0.020），IL21（p=0.008），与基线相比,IL7(p=0.001)和IL8(p=0.007);蛋白质MIP1α(p=0.048)和MIP1β(p=0.047);和TNFα(p=0.047)。治疗后,第1组（激光+氯硝西泮）与基线相比，IL21（p=0.045）和IL7（p=0.009）有显著差异，而第4组（氯硝西泮）在IL13中显示出显着差异（p=0.036），IL2(p=0.020)和IL4(p=0.001)。在第2组(假激光安慰剂)中没有记录到显著差异。
结论：低能级二极管激光是BMS的良好治疗选择，导致患者症状和唾液生物标志物的减少。然而,需要对干预协议和激光强度参数进行标准化，以得出更可靠的结论。
方法：随机，进行了单盲临床试验，涉及89例患者，分为以下组：第1组（激光，Helbo®Theralite激光3D袖珍探头+氯硝西泮（n=20），第2组（假激光安慰剂）（n=19），第3组(激光)(n=21)和第4组(氯硝西泮)(n=18)。根据视觉模拟量表（VAS）对症状强度进行评分。在治疗前和治疗后进行唾液酸测定，和口干症清单，进行了口腔健康影响概况-14（OHIP-14）和迷你营养评估（MNA）问卷。在唾液样品中测量了以下标记：白介素（IL2，IL4，IL5，IL6，IL7，IL8，IL1β，IL10、IL12、IL13、IL17、IL21和IL23)，蛋白质(MIP-3α，MIP-1α和MIP-1β)，GM-CSF,干扰素γ（IFNγ），干扰素诱导的T细胞α化学引诱物（ITAC），Fractalkine和肿瘤坏死因子α（TNFα）。
结果：治疗后，第1组（激光氯硝西泮）（p=0.029）和第3组（激光）（p=0.005）的VAS评分显着降低。反过来,第3组（激光）显示fractalkine的唾液浓度降低（p=0.025）;白细胞介素IL12（p=0.048），IL17（p=0.020），IL21（p=0.008），与基线相比,IL7(p=0.001)和IL8(p=0.007);蛋白质MIP1α(p=0.048)和MIP1β(p=0.047);和TNFα(p=0.047)。治疗后,第1组（激光+氯硝西泮）与基线相比，IL21（p=0.045）和IL7（p=0.009）有显著差异，而第4组（氯硝西泮）在IL13中显示出显着差异（p=0.036），IL2(p=0.020)和IL4(p=0.001)。在第2组(假激光安慰剂)中没有记录到显著差异。
结论：低能级二极管激光是BMS的良好治疗选择，导致患者症状和唾液生物标志物的减少。然而,需要对干预协议和激光强度参数进行标准化，以得出更可靠的结论。
