NCT05309070

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Zagreb · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burning Mouth Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	N-acetyl cysteine	Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months
OTHER	placebo	Control group will receive a placebo, in unmarked boxes, during two months

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2022-04-04
• Last updated: 2025-05-14

Locations

1 site across 1 country: Croatia