The aim of this study is to evaluate the effect of oral zinc on oral lichen planus lesions. Patients with oral lichen planus that referred to oral and maxillofacial medicine department of Shiraz dental school will be enrolled. Those with special systemic disease or use of medications that influence on zinc uptake will be excluded from the study. In this study,40 patients will be randomly assigned to the zinc capsules 250 mg and placebo (a capsule without active medication) for 8 weeks(twice a day), and healing based on type,extention and pain intensity will be evaluated 2 week, 2 month and 3 month after beginning of study. All patients use triamcinolone mouthwash 0.1 % for 3 week, simultaneously with oral zinc consumption.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062213406N2
Registration date:2015-08-10, 1394/05/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-10, 1394/05/19
Registrant information
Name
Fahimeh Rezazadeh
Name of organization / entity
Dental school of shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 9917
Email address
rezazadehf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of oral zinc treatment in patients with oral lichen planus
Public title
effect of zinc in oral lichen planus treatment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: symptomatic oral lichen planus
exclusion criteria:lichenoid reactions;immune deficiency ; consumption of medications that affect serum zinc level ; mal-absorption disorder ;The factor that changes the absorption of zinc(pregnancy ,lactation, iron and calcium supplement) ;alcoholism ; drug therapy for lichen planus for 2 last month ; acute phase of post surgery ;malignancy;Patients who are not willing to participate in the study ;smoking ; sensitivity to zinc ;consumption of systemic steroids
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Shiraz University of Medical Science
Street address
Shiraz, Iran
City
Shiraz
Postal code
Approval date
2015-06-27, 1394/04/06
Ethics committee reference number
ir.sums.rec.1394.47
Health conditions studied
1
Description of health condition studied
lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
healing of oral lesion
Timepoint
2 week-2 month-3month
Method of measurement
size of lesion- oral extension- type of disease- pain level
Secondary outcomes
1
Description
recurency
Timepoint
2 and 3 month
Method of measurement
recurency period
Intervention groups
1
Description
zinc sulfate 250mg
twice a day
for 8 week
Category
Treatment - Drugs
2
Description
placebo
zinc capsule without content
twice a day
8 week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Fahimeh Rezazadeh
Street address
Shiraz Dental School, Gom Abad, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciense
Full name of responsible person
Mahtab Memarpour
Street address
Iran, Shiraz, Shiraz University of Medical Sciense
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciense
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
Shiraz Dental School
Full name of responsible person
Fahimeh Rezazadeh
Position
Assistant professor of oral medicine
Other areas of specialty/work
Street address
Shiraz Dental School, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3634 7648
Fax
Email
rezazadehf@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Fahimeh Rezazadeh
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz Dental school, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1634 7648
Fax
Email
rezazadehf@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Fahimeh Rezazadeh
Position
Assistant professor of oral medicine
Other areas of specialty/work
Street address
Shiraz Dental School, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3634 7648
Fax
Email
rezazadehf@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)