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

NCT ID: NCT05309070

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burning Mouth Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double-blind randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

female patients with primary burning mouth syndrome

Group Type ACTIVE_COMPARATOR

N-acetyl cysteine

Intervention Type DIETARY_SUPPLEMENT

Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months

Control group

female patients with primary burning mouth syndrome

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-acetyl cysteine

Study group will receive N-acetyl cysteine in unmarked boxes, in a daily dose of 1200 mg during two months

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Božana Lončar Brzak

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Dental Medicine, University of Zagreb

Zagreb, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Omega-3 Hydrogel and Prevention of Oral Mucositis
NCT05214495 COMPLETED PHASE2/PHASE3