Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04884503
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2021-04-27
Brief Title:
Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome
Sponsor:
Wroclaw Medical University
Organization:
Wroclaw Medical University
Study Overview
Official Title:
Assessment of the Effectiveness of the Selected Treatment Method and Psychological Disorders of Primary Burning Mouth Syndrome
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hypersensitivityThe complaints are usually bilateral of moderate intensity they persist for a minimum of 4-6 months and concern the clinically unchanged membrane mucousThe 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
Detailed Description:
The burning mouth syndrome BMS is a chronic pain syndrome of the oral mucosa Patients have 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 mucousThe 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
The first step is to determine the specific type of BMS ie to exclude a causal relationship with the existing local factors general diseases and medications taken
The pathophysiology of Primary Burning Mouth Syndrome is unclear Due to the lack of morphological changes in the oral cavity with the simultaneous occurrence of troublesome pain symptoms it is now assumed that pain in BMS has a neuropathic mechanism
Among the psychotropic drugs the most commonly used in the treatment of BMS was clonazepam a drug with anticonvulsant and anxiolytic properties
In this study the investigators used clonazepam because of which it has proven effectiveness in therapy in combination with a tongue protector made for the purpose of the test Use of a tongue protector in the form of a bag put on it 3 times a day is relatively new method of treatment which is to exclude the detachment of the tongues para-function on burning
60 patients were qualified for the study of which 57 patients including 34 women and 23 men aged 47-77 years took part in the program
Pain assessment The symptoms of pain intensity BMS were assessed using the VAS Visual Analog Scale The duration of burning was also assessed the type of burning according to Levis the occurrence of taste disturbances and their determination subjective feeling of dry mouth place of burning sensation tongue palate lips mucosa of the mouth vestibule with gums cheek mucosa The psychologist cooperating in the project conducted and then interpreted four psychological tests STAI state and trait anxiety inventory and the Beck Anxiety Scale BAI and the Beck Depression Scale BDI Moreover the WHOQOL quality of life test was carried out - according to WHO
A follow-up examination was performed on the day of treatment completion and 3 months later
The first step is to determine the specific type of BMS ie to exclude a causal relationship with the existing local factors general diseases and medications taken
The pathophysiology of Primary Burning Mouth Syndrome is unclear Due to the lack of morphological changes in the oral cavity with the simultaneous occurrence of troublesome pain symptoms it is now assumed that pain in BMS has a neuropathic mechanism
Among the psychotropic drugs the most commonly used in the treatment of BMS was clonazepam a drug with anticonvulsant and anxiolytic properties
In this study the investigators used clonazepam because of which it has proven effectiveness in therapy in combination with a tongue protector made for the purpose of the test Use of a tongue protector in the form of a bag put on it 3 times a day is relatively new method of treatment which is to exclude the detachment of the tongues para-function on burning
60 patients were qualified for the study of which 57 patients including 34 women and 23 men aged 47-77 years took part in the program
Pain assessment The symptoms of pain intensity BMS were assessed using the VAS Visual Analog Scale The duration of burning was also assessed the type of burning according to Levis the occurrence of taste disturbances and their determination subjective feeling of dry mouth place of burning sensation tongue palate lips mucosa of the mouth vestibule with gums cheek mucosa The psychologist cooperating in the project conducted and then interpreted four psychological tests STAI state and trait anxiety inventory and the Beck Anxiety Scale BAI and the Beck Depression Scale BDI Moreover the WHOQOL quality of life test was carried out - according to WHO
A follow-up examination was performed on the day of treatment completion and 3 months later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None