The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome

NCT05309070 | Completed

• 1 other identifier: 05-PA-30-III-12/2021.
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to examine the efficacy of N-acetyl cysteine in the treatment of burning mouth syndrome. A control group of patients with burning mouth syndrome will receive a placebo. The effect of the therapy will be monitored with the help of the visual-analogue scale (VAS) and the oral health-related quality of life questionnaire (OHIP-14).

Conditions

Burning Mouth Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in quality of life

  measured with OHIP-14 (Oral Health-Related Quality of Life questionnaire); the answer options with their respective values were as follows: 0 = never, 1 = rarely, 2 = sometimes, 3 = repeatedly, 4 = always, with a maximum score of 56. The higher the score, the worse quality of life.

  up to 8 weeks

Secondary Outcomes (1)

• Change in subjective symptoms of burning mouth

  up to 8 weeks

Study Arms (2)

Study group

ACTIVE COMPARATOR

female patients with primary burning mouth syndrome

Dietary Supplement: N-acetyl cysteine

Control group

PLACEBO COMPARATOR

female patients with primary burning mouth syndrome

Other: placebo

Interventions

N-acetyl cysteine DIETARY_SUPPLEMENT

Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months

Study group

placebo OTHER

Control group will receive a placebo, in unmarked boxes, during two months

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of burning mouth syndrome

You may not qualify if:

• pregnancy, breastfeeding or pregnancy planning
• anamnestic data about active gastric or duodenal ulcer
• decreased levels of serum iron or B vitamins

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: double-blind randomized controlled trial

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: May 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)