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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burning Mouth Syndrome

Intervention / Treatment
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* Dietary Supplement: N-acetyl cysteine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>female patients with primary burning mouth syndrome | Dietary Supplement: N-acetyl cysteine<br>* Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months<br>|
| Placebo Comparator: Control group<br>female patients with primary burning mouth syndrome | Other: placebo<br>* Control group will receive a placebo, in unmarked boxes, during two months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |