The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
Primary Purpose
Burning Mouth Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
N-acetyl cysteine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome
Eligibility Criteria
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
Sites / Locations
- School of Dental Medicine, University of ZagrebRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Study group
Control group
Arm Description
female patients with primary burning mouth syndrome
female patients with primary burning mouth syndrome
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05309070
Brief Title
The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
Official Title
The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blind randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
female patients with primary burning mouth syndrome
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
female patients with primary burning mouth syndrome
Intervention Type
Dietary Supplement
Intervention Name(s)
N-acetyl cysteine
Intervention Description
Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Control group will receive a placebo, in unmarked boxes, during two months
Primary Outcome Measure Information:
Title
Change in quality of life
Description
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.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in subjective symptoms of burning mouth
Description
measured with VAS scale (visual analogue scale) grading from 0 to 10 (0 = without symptoms, 10 = worst possible symptoms)
Time Frame
up to 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Božana Lončar Brzak
Phone
+38514899215
Email
loncar@sfzg.hr
Facility Information:
Facility Name
School of Dental Medicine, University of Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Božana Lončar Brzak, Assist.Prof.
Phone
+38514899215
Email
loncar@sfzg.hr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
We'll reach out to this number within 24 hrs