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

Burning Mouth Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309070
• Other study ID #: 05-PA-30-III-12/2021.
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2022
• Source: University of Zagreb
• Contact: Božana Loncar Brzak
• Phone: +38514899215
• Email: loncar[@]sfzg.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of burning mouth syndrome

Exclusion Criteria:

• pregnancy, breastfeeding or pregnancy planning

• anamnestic data about active gastric or duodenal ulcer

• decreased levels of serum iron or B vitamins

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Croatia	School of Dental Medicine, University of Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in subjective symptoms of burning mouth	measured with VAS scale (visual analogue scale) grading from 0 to 10 (0 = without symptoms, 10 = worst possible symptoms)	up to 8 weeks