Evaluation of the efficacy of clonazepam oral paste on pain of burning mouth syndrome
Design
The total sample size is 24 patients.12 participants in the evaluation group and 12 participants in the control group will be enrolled. Patients with recurrent aphthous stomatitis will be divided randomly (block randomization) into 2 experimental and control groups. In experimental and control groups patients will receive clonazepam oral paste and clonazepam tab 0.5 mg respectively, three times a day for 30days.
Settings and conduct
ااThis study is double blinded. The outcome assessor and data analyser will be blind to the type of prescribed treatment. The patients who will be referred to Shiraz Dental School for their recurrent aphthous stomatitis will be enrolled.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients with primary BMS whose disease have been confirmed by a specialist
Exclusion criteria: The patients with primary BMS who have been under treatment for BMS during previous month The patients who have taken anxiolytics, antidepressant or any other similar medications
Intervention groups
Intervention group: The patients will receive clonazepam oral paste 3 times daily.
Control group: The patients will be prescribed ۰.5 mg clonazepam tab in order to suck the tab for 5 minutes and spit out the remaining tab 3 times daily.
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120101008585N13
Registration date:2022-02-26, 1400/12/07
Registration timing:prospective
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of clonazepam oral paste on pain of burning mouth syndrome
Public title
Evaluation of the efficacy of clonazepam oral paste on pain of burning mouth syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with primary BMS whose disease have been confirmed by a specialist
Exclusion criteria:
The patients with primary BMS who have been under treatment for BMS during previous month
The patients who have taken anxiolytics, antidepressant or any other similar medications
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Each block with 4 allocations, consisting of 2 allocations for intervention and 2 for the control group were considered. Six possible sequences of treatment allocation in each block were listed and each one was written on a card. Each time a block had been selected and the sequence of treatments was registered until the treatment allocations become completed for all 24 patients (6 blocks).
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatment prescription will be done by a researcher, but pain analysis will be done by another researcher and he will be blind to the type of prescribed treatment. Also the data analyser will be blind to the type of prescribed treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.SUMS.DENTAL.REC.1399.095
Health conditions studied
1
Description of health condition studied
Burning mouth syndrome
ICD-10 code
T28.0XXS
ICD-10 code description
Burn of mouth and pharynx, sequela
Primary outcomes
1
Description
The amount of pain
Timepoint
Day 0,7,14,21,30
Method of measurement
Visual anloge scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients will receive clonazepam oral paste three times a day for 30days.
Category
Treatment - Drugs
2
Description
Control group: The patients will receive clonazepam tab 0.5 mg and suck it for 5 minutes three times a day for 30days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Fatemeh Lavaee
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Rezaianzade
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3212 2438
Email
lavaeef@sums.ac.ir
Grant name
Grant code / Reference number
20796
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Statistical analysis file
When the data will become available and for how long
The data will be given to the requester by email.
To whom data/document is available
The data will be given to the requester by email
Under which criteria data/document could be used
The data will be given to the requester by email.
From where data/document is obtainable
The data will be given to the requester by email.
What processes are involved for a request to access data/document