the present study was designed to evaluation of the effectiveness of oral zinc sulfate to improve symptoms of burning mouth syndrome. Sixty patients from Zahedan Dental School would be selected. inclusion criteria: is patient's with burning mouth syndrome and exclusive criteria is patient's with known systemic disease, patient's under 18 years, pregnancy, patient's with oral denture. In each patient, is receiving zinc sulfate and control group receive placebo after finishing treatment, after 3 month patients will be evaluated for severity of burning.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312093133N5
Registration date:2014-09-26, 1393/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-26, 1393/07/04
Registrant information
Name
Fateme Arbabi Kalati
Name of organization / entity
Dental school of Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 1814
Email address
farbabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2015-07-02, 1394/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of oral zinc sulfate therapy on burning severity in burning mouth syndrome
Public title
Evaluation the effect of oral zinc sulfate therapy on burning severity in burning mouth syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients with burning mouth syndrome
exclusive criteria : patients with known systemic disease; patients under 18 years; pregnancy; patients with oral denture
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Hesabi Squer, Zahedan,Iran Zahedan Sistan and Baluchestan Iran, Islamic Republic Of
City
Zahedan
Postal code
Approval date
2014-05-11, 1393/02/21
Ethics committee reference number
6334
Health conditions studied
1
Description of health condition studied
burning mouth syndrom
ICD-10 code
F59
ICD-10 code description
Unspecified behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
decreasing of burning Mouth
Timepoint
after 3 months
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
well being of xerostomia
Timepoint
3 months
Method of measurement
lent soma
Intervention groups
1
Description
In control group placebo capsules would be given to patients for 3 month
Category
Treatment - Drugs
2
Description
In intervention group zinc sulfate capsules (220 mg) would be given to patients for 3 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistery
Full name of responsible person
fateme Arbabi-Kalati
Street address
Oral medicine departeman,Faculty of dentistery, Azadegan aven, Zahedan, Iran Zahedan Sistan and Baluchestan Iran, Islamic Republic Of
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences,
Full name of responsible person
Hamidreza Sagheb
Street address
Zahedan University of Medical Sciences, Hesabi Squer, Zahedan, Iran Islamic Republic Of
City
Zahedan
Grant name
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of dentistery
Full name of responsible person
Fateme Arbabi-Kalati
Position
lecturer
Other areas of specialty/work
Street address
Oral medicine departeman, Faculty of dentistery, Azadegan aven, Zahedan, Iran Islamic Republic Of
City
Zahedan
Postal code
Phone
+98 54 1241 4001
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of dentistery
Full name of responsible person
Fateme Arbabi-Kalati
Position
spacialist
Other areas of specialty/work
Street address
Oral medicine departeman, Faculty of dentistery, Azadegan aven, Zahedan, Iran Islamic Republic Of
City
Zahedan
Postal code
Phone
+98 54 1241 4001
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of dentistery
Full name of responsible person
Fateme Arbabi-Kalati
Position
spacilist
Other areas of specialty/work
Street address
Oral medicine departeman, Faculty of dentistery, Azadegan aven, Zahedan, Iran Islamic Republic Of
City
Zahedan
Postal code
Phone
+98 54 1241 4001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)