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

Not Applicable

• Conditions: Burning Mouth Syndrome
• Interventions: Dietary Supplement: N-acetyl cysteine; Other: placebo

• Registration Number: NCT05309070
• Lead Sponsor: University of Zagreb

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).

Detailed Description

The research will include patients who come to the Department of Oral Medicine at the Faculty of Dentistry in Zagreb, and who have been diagnosed with burning mouth syndrome. It is planned to gather a total of 60 patients, 30 patients in the treatment group and 30 in the placebo group.

The purpose and protocol of the research will be explained to the patients. If they are willing to participate, they will sign an informed consent previously approved by the Ethics Committee of the Faculty of Dentistry. They will fill in the OHIP-14 questionnaire and the VAS scale, grading from 0-10, where 0 indicates a condition without symptoms, and 10 the strongest possible intensity of symptoms. They will be randomly assigned to a therapeutic or placebo group and will receive the medicine in an unmarked box. The drug will be taken for two months at a dose of 1200 mg per day. After that, they will come for a check-up and re-complete OHIP-14 and record the intensity of symptoms according to the VAS scale.

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Status Verified: 2022-05
• Study Start: 2022-05-01
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• clinical diagnosis of burning mouth syndrome

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	N-acetyl cysteine	female patients with primary burning mouth syndrome
Control group	placebo	female patients with primary burning mouth syndrome

Primary Outcome Measures

Name	Time	Method
Change in quality of life	up to 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in subjective symptoms of burning mouth	up to 8 weeks	measured with VAS scale (visual analogue scale) grading from 0 to 10 (0 = without symptoms, 10 = worst possible symptoms)

Trial Locations

Locations (1)

School of Dental Medicine, University of Zagreb; 🇭🇷 Zagreb, Croatia