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临床试验/NCT06217731
NCT06217731已完成不适用

Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome Before and After Treatment With Low-Level Laser Therapy and Clonazepam: A Randomized, Single-Blind Clinical Trial

Universidad de Murcia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Pain EVA

研究概览

简要总结

Burning Mouth Syndrome (BMS) is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions. Multiple therapies have been investigated without conclusive results.Objective: To analyse the efficacy of treatment with Clonazepam (Rivotril) and Low Power Diode Laser Therapy in patients with Burning Mouth Syndrome and to study the markers of inflammation present in the patients' saliva.

Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).

详细描述

Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients who were included in Group 1 (n=20) were treated with the low power diode laser Helbo® Theralite Laser 3D Pocket Probe once a week for one month and Rivotril 0.25mg once every 24 hours for one month. Group 2 (n=19) were treated with the same laser once a week for one month, but with the tip not activated as a placebo treatment. Group 3 (n=21) were only treated with Helbo® laser once a week for one month and Group 4 (n=18) had only Rivotril 0.25mg once a day for one month. The patients were not aware of the different groups on which this study is based.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis Burning Mouth Syndrome (BMS) burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions

排除标准

  • Pregnant or lactating patients
  • Oncology patients
  • Sjögren's syndrome

研究组 & 干预措施

Group1 laser + clonazepam

Active Comparator

Group 1 (n=20) were treated with the Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month and Rivotril ( clonazepam) 0.25mg once every 24 hours for a month.

干预措施: Laser+clonazepam (Combination Product)

group 2 Laser Sham

Sham Comparator

Group 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated

干预措施: Laser Sham (Device)

group3 laser

Experimental

Group 3 (n=21) were treated with the Helbo® laser once a week for a month.

干预措施: Laser (Device)

group 4 clonazepam

Experimental

Group 4 (n=18) were treated with Rivotril 0.25mg once a day for a month.

干预措施: Clonazepam (Drug)

结局指标

主要结局

Pain EVA

时间窗: Baseline through 1 month

The intensity of the symptoms was rated using a Visual Analog Scale (VAS) where 0=no pain and 10=maximum possible pain.

次要结局

  • salivary biomarkers(Baseline through 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pia Lopez Jornet

Principal investigator

Universidad de Murcia

研究点 (1)

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