MedTrace Logo

Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome

NCT04884503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-07-22

No results posted yet for this study

Summary

The burning mouth syndrome (BMS) is a chronic pain syndrome of the oral mucosa. Feels like experiencing a burning sensation, pain, stinging, or numbness in the mouth along with a feeling of dryness, paraesthesia, taste disturbance or hypersensitivity.The complaints are usually bilateral, of moderate intensity, they persist for a minimum of 4-6 months and concern the clinically unchanged membrane mucous.The psychiatric aspect of BMS is very important. The presence of BMS has been shown to be associated with depression, increased anxiety levels, hypochondria, and carcinophobia and emotional instability

Conditions

  • Burning Mouth Syndrome
  • Glossodynia

Interventions

DRUG

Clonazepam tablets

Dosing of clonazepam was as follows: in the first week, 1 mg to be sucked for 2 minutes, then swallowed (once a day in the morning), in the second week, 1 mg to be sucked for 2 minutes, and then swallowed (twice a day in the morning and one hour before falling asleep), in the third week, 1 mg to be sucked for 2 minutes and in the fourth week 1 mg to be sucked for 2 minutes, then swallowed (once a day in the morning)

DEVICE

tongue pads

wearing a tongue pad 3 times a day for 20 minutes for 4 weeks

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • tomasz konopka, prof · Wroclaw Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-12
Primary Completion
2020-04-03
Completion
2020-09-06

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884503 on ClinicalTrials.gov