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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06195137
Other study ID # WCHSIRB-D-2021-407
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2021
Est. completion date June 23, 2023

Study information

Verified date December 2023
Source Sichuan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to evaluate the efficacy of caffeine and alpha-lipoic acid in the treatment of burning mouth syndrome by symptom assessment with visual analogue scale.


Description:

The etiology of BMS is multifactorial, involving a complex interplay of neuropathic, psychological, neuroendocrine, and immunological factors. Neurologically, BMS has been categorized into three subtypes: peripheral small fiber neuropathy, subclinical trigeminal neuropathy, and inhibitory dopaminergic deficiency. Neuroimaging and peripheral nerve studies have further implicated altered brain activation patterns and increased expression of specific receptors like TRPV1 and P2X3 in the pathogenesis of BMS. Hormonal imbalances, particularly in estrogen levels, have also been suggested to contribute to contribute to the condition. Caffeine, a xanthine alkaloid chemically known as 1,3,7-trimethylxanthine, is recognized for its diverse biological functions. As a central nervous system stimulant, its primary mechanism involves antagonizing adenosine receptors, thereby enhancing the release of neurotransmitters such as dopamine and norepinephrine, which are known to play roles in analgesic pathways. Caffeine is also noted for its neuroprotective properties and is theorized to reduce the risk of neurodegenerative diseases. It affects the central processing of pain and is involved in regulating circadian rhythms and sleep-wake cycles. Additionally, caffeine has mild anti-inflammatory properties. Its stimulatory effects may also improve mood and cognitive function.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date June 23, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Adults over 18 years of age - Diagnosis of BMS according to the 3rd edition of the International Classification of Headache Disorders (ICHD-3) - Daily intraoral burning or dysaesthesia lasting for more than 2 hours for over 3 months - Normal oral mucosa and sensory testing - Condition not better accounted for by another ICHD-3 diagnosis Exclusion Criteria: 1. Secondary BMS due to local or systemic disorders 2. Prior treatment for BMS 3. Psychiatric or progressive neurological disorders 4. Systemic disorders potentially associated with oral disease 5. Long-term history of smoking, drinking, or medication use 6. Consumption of caffeinated products 7. Poor oral hygiene 8. Abnormal blood test results (including blood count, glucose, serum iron, ferritin and transferrin, folic acid, or vitamin B12 levels) 9. Incomplete medical records 10. Unwillingness to participate

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Caffeine
caffeine supplementation
Drug:
Alpha Lipoic Acid
600-800 mg ALA

Locations

Country Name City State
China West China Hospital of Stomatology, Sichuan University Chengdu

Sponsors (1)

Lead Sponsor Collaborator
Lu Jiang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) During the interview or telephone follow-up with the patient, ask the patient to fill in the VAS rating scale. Baseline and 2 weeks after intervention or observation
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