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

NCT04884503 | Completed Phase 2

• 1 other identifier: Kb668/2018
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BMS, , clonazepam, BMS psychological disturbance

Outcome Measures

Primary Outcomes (4)

• assessment of pain

  combining the use of clonazepam versus the group wearing a tongue protector Tongue protector was use in order to exclude occlusal parafunction. VAS (visual analog scale) was use to asses pain score before and after therapy scale from 0 to 10 0 no pain 10 maximum pain

  1 month and 3 months after therapy

• Assessment of the depression patients diagnosed with BMS.

  Assessment depression Beck depresion scale Questionnaire scale from 0 to 28 0 no deppresion 28 depression

  1 month and 3 months after therapy

• Assessment of the sleepiness patients diagnosed with BMS.

  assessment of side effects when taking clonazepam such as sleepiness was assessed on the basis of surveys with patients: Athenian Insomnia Scale Questionnaire scale from 0 to 24 0 no sleep disorders 24 insomnia

  1 month and 3 months after therapy

• assessment of side effects : slowness

  assessment of side effects when taking clonazepam such as dry mouth, slowness, was assessed on the basis of surveys with patients

  1 month and 3 months after therapy

Study Arms (2)

Patients diagnosed with BMS traeting with Clonazepam

EXPERIMENTAL

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)

Drug: Clonazepam tablets

Patients diagnosed with BMS treating with tongue pads

ACTIVE COMPARATOR

patients wearing tongue pads 3 times a day for 20 minutes for 4 weeks to exclude parafunctions

Device: tongue pads

Interventions

Clonazepam tablets DRUG

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)

Also known as: patients treating with clonazepam

Patients diagnosed with BMS traeting with Clonazepam

tongue pads DEVICE

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

Also known as: patients treating with tonque pads

Patients diagnosed with BMS treating with tongue pads

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of BMS for at least 6 months
• no clinical changes in the oral cavity that are clinically verifiable and may affect symptoms,
• no previous BMS therapy
• age over 18

You may not qualify if:

• V and VII nerve neuralgia
• patients with uncontrolled diabetes mellitus,
• thyroid disease, anemia,
• Sjogren's disease and
• connective tissue disease (fibromyalgia),
• patients after prior surgical / neurosurgical treatment of the head,
• oncological treatment (radiotherapy),
• pregnant women,
• the occurrence of clinical pathologies in the oral cavity that may cause pain,
• deficiencies of vitamin B12, folic acid

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Jacek Zborowski

Wroclaw, Lower Silesian Voivodeship, 52-311, Poland

Location

MeSH Terms

Conditions

Burning Mouth Syndrome; Glossalgia

Interventions

Clonazepam

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• tomasz konopka, prof

  Wroclaw Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 13, 2021
• Study Start: January 12, 2019
• Primary Completion: April 3, 2020
• Study Completion: September 6, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)