Burning Mouth Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTN-acetyl cysteine
Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months
OTHERplacebo
Control group will receive a placebo, in unmarked boxes, during two months
Sponsors
University of Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
double-blind randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Croatia
Outcome results
None listed