U.S. flag

An official website of the United States government

Skip to main page content
Unknown status
Verified  2022-05 by Božana Lončar Brzak, University of Zagreb
Last known status was: Recruiting

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

ClinicalTrials.gov ID NCT05309070
Sponsor University of Zagreb
Information provided by Božana Lončar Brzak, University of Zagreb (Responsible Party)
Last Update Posted 2022-05-25
Bookmark

Study Overview

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.

Show less
Official Title
The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome
Conditions
Burning Mouth Syndrome
Intervention / Treatment
  • Dietary Supplement: N-acetyl cysteine
  • Other: placebo
  • Dietary Supplement: N-acetyl cysteine
  • Other: placebo
Other Study ID Numbers
  • 05-PA-30-III-12/2021.
Study Start (Actual)
2022-05-01
Primary Completion (Estimated)
2023-12-31
Study Completion (Estimated)
2024-02-28
Enrollment (Estimated)
60
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: Božana Lončar Brzak

Phone Number: +38514899215

Email: loncar@sfzg.hr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
Show less
Ages Eligible for Study
18 Years to 70 Years (AdultOlder Adult )
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

/
Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Interventional Model Description: double-blind randomized controlled trial
Masking : Quadruple (ParticipantCare ProviderInvestigatorOutcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Active Comparator: Study group
female patients with primary burning mouth syndrome
Intervention/Treatment 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

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

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Change in quality of lifemeasured 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 mouthmeasured with VAS scale (visual analogue scale) grading from 0 to 10 (0 = without symptoms, 10 = worst possible symptoms)up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
University of Zagreb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2022-03-15
First Submitted that Met QC Criteria
2022-03-24
First Posted
2022-04-04
Study Record Updates
Last Update Submitted that met QC Criteria
2022-05-18
Last Update Posted
2022-05-25
Last Verified
2022-05

More Information

/

Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No