Treatment effect of Melatonin on Burning Mouth Syndrome
Design
Sample size 15 patients in each group randomization: simple clinical trial: phase 2 or 1
Settings and conduct
Patients with Burnin Mouth Syndrome and inclusion criteria will be divided into two groups randomly and evaluated for 24 Weeks. Melatonin will be provided, patients and data analyzers will be blind to groups of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: burning mouth at all times; lack of systemic disease and chronic medication; patients over 18 years of age; use of smoking; no oral lesion.
Exclusin criteria: elderly people with glaucoma; those who take aspirin or heparin or warfarin; those who take acetonol and metoprolol because they reduce the effect of melatonin; epilepsy.
Intervention groups
Melatonin group
Placebo group
Main outcome variables
Improvement burning and sleep disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141220020377N3
Registration date:2019-08-14, 1398/05/23
Registration timing:prospective
Last update:2019-08-14, 1398/05/23
Update count:0
Registration date
2019-08-14, 1398/05/23
Registrant information
Name
Tahereh Nosratzehi
Name of organization / entity
Dental School of Zahedan University
Country
Iran (Islamic Republic of)
Phone
+98 915 348 0151
Email address
nosratzehi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness Of Melatonin in patients with Burning Mouth syndrome
Public title
Melatonin in patients with Burning Mouth syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Burning mouth at all times
Lack of Systemic Disease and chronic medication
Patients over 18 years of age
No use of Smoking
Lack of oral lesion
Exclusion criteria:
Elderly people with glaucoma
Those who take aspirin or heparin or warfarin
Those who take acetonol and metoprolol because they reduce the effect of melatonin
Patients with epilepsy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomizd Stratified Blocking
In this study, patients are randomly divided into two groups. Randomization is performed Based on the random numbers table obtained from www.randomizer.org. Even number will be allocated in intervention group and odd number in control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are examined by a dentistry student who is blind to the drug before treatment and VAS (Visual Analog Scale) is evaluated.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University Of Medical Science
Street address
Oral Medicine Department, Faculty Of Dentistry, Azadegan Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2019-05-26, 1398/03/05
Ethics committee reference number
IR.ZAUMS.REC.1398.157
Health conditions studied
1
Description of health condition studied
Burning Mouth Syndrome
ICD-10 code
T28.5
ICD-10 code description
Burning Mouth Syndrome
Primary outcomes
1
Description
Level of Sensation
Timepoint
The First Visit, 8 weeks Later, 4 weeks Later,4 weeks Later, 8 weeks Later
Method of measurement
Visual Analogue Scale
2
Description
Average sleep disorder
Timepoint
The First Visit, 24 weeks Later
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group patients will use Melatonin Tab 3 Mg (Iran Construction of A-lHavi Company) 4 times a day for 5 month.
Category
Treatment - Drugs
2
Description
Control group: In Control group patients will use PlaceboTab 4 times a day for 5 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral medicine Department, Faculty Of Dentistry
Full name of responsible person
Dr.Tahereh Nosratzehi
Street address
Oral Medicine Department, Faculty Dentistry, Azadegan Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3401 3041
Email
Nosratzehi@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taheri
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5796
Email
taheri@zaums.ac.ir
Grant name
Vice chancellor for research, Zahedan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Tahereh Nosratzehi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral Medicine Department, Faculty of Dentistry, Azadegan Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3401 3041
Email
Nosratzehi@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Tahereh Nosratzehi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral Medicine Department, Faculty of Dentistry, Azadegan Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699653
Phone
+98 54 3401 3041
Email
Nosratzahi@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Tahereh Nosratzehi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699653
Phone
+98 54 3401 3041
Email
Nosratzehi@zaums.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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
No- There is no plan to make this available at the present time
When the data will become available and for how long
starting 10 months after publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
It is permitted to use the data in other studies with reference.
From where data/document is obtainable
Nosratzehi@zaums.ac.ir
What processes are involved for a request to access data/document