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Clinical Effects and Mechanisms of Pregabalin in Modulating Central Sensitization in Burning Mouth Syndrome: An Exploration Based on Multimodal Magnetic Resonance Imaging

Clinical Effects and Mechanisms of Pregabalin in Modulating Central Sensitization in Burning Mouth Syndrome: An Exploration Based on Multimodal Magnetic Resonance Imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101369
Enrollment
Unknown
Registered
2025-04-24
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning mouth syndrome

Interventions

Intervention group:The doctor instructed the study participants to use the drug correctly, and to abstain from alcohol, caffeine and other diets after taking pregabalin. During the intervention, the d

Sponsors

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. International Classification of Headaches, Third Edition (ICHD-3) BMS diagnostic criteria: Oral pain lasting more than 2 hours per day for more than 3 months; characterised by burning pain confined to the superficial oral mucosa; may be accompanied by tongue numbness, dry mouth, dysgeusia, or other uncomfortable symptoms; The burning sensation persists or increases in intensity during the day and does not interfere with eating, drinking, or sleeping; The appearance of the oral mucosa is normal, and the clinical examination of the oral mucosa, including sensory examination, is normal; No local or systemic causes of burning pain in the oral mucosa, such as oral mucositis, oral candidiasis, glossitis, Sjogren's syndrome, diabetes, anemia, and cardiovascular disease, have been found. 2. BMS Subjects Inclusion Criteria: Meets BMS diagnostic criteria; Age>=18 and = 3 months; Visual Analogue Score (VAS) > 3 points; Understand, agree to participate in this study and sign the informed consent form, and cooperate with the treatment and follow-up;

Exclusion criteria

Exclusion criteria: 1. There are detectable organic lesions accompanied by pain in the oral mucosa, tooth or periodontal tissue, such as ulcers, deep caries, periodontitis, etc 2. History of orofacial neuralgia, such as trigeminal neuralgia, glossopharyngeal neuralgia, diabetic neuropathy, post-chemotherapy neuropathy 3. History of head and neck radiotherapy, accompanied by salivary gland disease or other oral mucosal diseases 4. Diabetes, autoimmune diseases or serious heart, liver, kidney and blood system and other important organ diseases 5. History of primary psychiatric illness (including major depressive disorder, major personality disorder) or substance abuse (other than caffeine or nicotine) 6. Combined with other chronic pain-related diseases (such as fibromyalgia, chronic headache, postherpetic neuralgia) 7. Combined with other vitamin B12 deficiency-related diseases (such as pernicious anemia) 8. Received treatment with central nervous system drugs (such as anti-anxiety and depressant drugs, GABAergic system-related drugs) within the past 1 month 9. Received treatment that may affect the central nervous system (such as transcranial magnetic stimulation, electrical stimulation, etc.) in the past 6 months 10. MRI contraindications: such as metal pacemakers, implantable defibrillators, metal implants in the brain, claustrophobia; 11. History of allergy to GABAergic system-related drugs (such as pregabalin, gabapentin, clonazepam). 12. Severe cognitive impairment or inability to cooperate with the assessment 13. Women who are pregnant or pregnant

Design outcomes

Primary

MeasureTime frame
Visual analog scale;

Secondary

MeasureTime frame
Concise McGill Pain Questionnaire results;Central Sensitization Scale score;Generalized anxiety scale score;Patient Health Questionnaire Depression Scale score;Oral Health Impact Scale score;Pittsburgh Sleep Quality Index Scale score;Gray Matter Volume (GMV)/Gray Matter Concentration (GMC);Central Metabolite Levels;Resting-State Brain Function;

Countries

China

Contacts

Public ContactGuoyao Tang

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

tanggy@shsmu.edu.cn+86 182 2106 6618

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026