NCT06195137

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

December 3, 2023

Last Update Submit

January 5, 2024

Conditions

CaffeineBurning Mouth Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Caffeine group

EXPERIMENTAL

Burning mouth syndrome (BMS) patients in Caffeine group were provided with BMS disease explanation and psychological counseling. Then they were told to drink instant coffee containing 120-150 mg of the active ingredient caffeine (2 bags of Nescafe Black Coffee, 1.8g each) at a certain point in time from 8:00 to 12:00 every day, for 2 consecutive weeks.

Dietary Supplement: Caffeine

Alpha Lipoic Acid (ALA) group

ACTIVE COMPARATOR

Burning mouth syndrome (BMS) patients in the ALA group were provided with BMS disease explanation and psychological counseling. Then they took α-lipoic acid (ALA) 3 times a day, after meals, 200 mg each time, for 2 consecutive weeks.

Drug: Alpha Lipoic Acid

Control gruop

NO INTERVENTION

Without intervention treatment, we provided BMS patients in Control group with disease explanation and psychological counseling for patients.

Interventions

CaffeineDIETARY_SUPPLEMENT

caffeine supplementation

Caffeine group
Alpha Lipoic AcidDRUG

600-800 mg ALA

Also known as: ALA
Alpha Lipoic Acid (ALA) group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary BMS due to local or systemic disorders
  • Prior treatment for BMS
  • Psychiatric or progressive neurological disorders
  • Systemic disorders potentially associated with oral disease
  • Long-term history of smoking, drinking, or medication use
  • Consumption of caffeinated products
  • Poor oral hygiene
  • Abnormal blood test results (including blood count, glucose, serum iron, ferritin and transferrin, folic acid, or vitamin B12 levels)
  • Incomplete medical records
  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Stomatology, Sichuan University

Chengdu, 610041, China

Location

Related Publications (1)

  • Wu C, Yuan P, Qiu X, Liu D, Xu Y, Xiao Y, Zhou S, Zhang Z, Cai S, Ding W, Xu X, Hou F, Jiang L. Short-Term Dietary Caffeine Intake for Alleviating Symptoms of Burning Mouth Syndrome: A Randomised Controlled Comparison With Alpha-Lipoic Acid. J Oral Rehabil. 2025 Jul;52(7):969-978. doi: 10.1111/joor.13957. Epub 2025 Mar 14.

    PMID: 40084800DERIVED

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

CaffeineThioctic Acid

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCarboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Lu Jiang

    Sichuan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 3, 2023

First Posted

January 8, 2024

Study Start

December 13, 2021

Primary Completion

June 15, 2023

Study Completion

June 23, 2023

Last Updated

January 8, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)