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

Sponsor

University of Zagreb (Other)

Overall Status

Recruiting

CT.gov ID

NCT05309070

Collaborator

(none)

Enrollment

Location

Arms

21.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Burning Mouth Syndrome	Dietary Supplement: N-acetyl cysteine Other: placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double-blind randomized controlled trialdouble-blind randomized controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study group female patients with primary burning mouth syndrome	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
Placebo Comparator: Control group female patients with primary burning mouth syndrome	Other: placebo Control group will receive a placebo, in unmarked boxes, during two months

Arm

Intervention/Treatment

Active Comparator: Study group

female patients with primary burning mouth syndrome

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

Placebo Comparator: Control group

female patients with primary burning mouth syndrome

Other: placebo

Control group will receive a placebo, in unmarked boxes, during two months

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Dental Medicine, University of Zagreb	Zagreb		Croatia	10000

Sponsors and Collaborators

University of Zagreb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Božana Lončar Brzak, Assistant Professor, University of Zagreb

ClinicalTrials.gov Identifier:

NCT05309070

Other Study ID Numbers:

05-PA-30-III-12/2021.

First Posted:

Apr 4, 2022

Last Update Posted:

May 25, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Burning Mouth Syndrome

Study Results

No Results Posted as of May 25, 2022