Objectives: To assess the effect of Nystatin therapy versus before treatment in patients with denture stomatitis.
Design: a before-after clinical trial.
Setting and conduct: The eligible patients with denture stomatitis who will refer to Dentistry School during the study period will be enrolled into the trial.
Inclusion criteria: Patients without teeth with complete denture.
Exclusion criteria: (a) having diabetes mellitus; (b) having immunodeficiency disorder; (c) history of using antibiotic, immunosuppressive drugs, radiotherapy, steroid, or antifungal drugs; (d) being simultaneously affected with other oral diseases such as gingivitis or periodontitis.
Intervention group: Treatment with Nystatin 100,000 U three times a day for 14 days.
Control group: In comparison with before intervention.
Primary outcome: (a) assessing the salivary level of IL-10 before treatment and 14 days after treatment; (b) assessing the salivary level of TNF-α before treatment and 14 days after treatment.
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508019014N73
Registration date:2015-08-03, 1394/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-03, 1394/05/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-07-22, 1393/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nystatin therapy versus before treatment in patients with denture stomatitis: a before-after clinical trial
Public title
Effect of Nystatin therapy versus before treatment in patients with denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients without teeth with complete denture.
Exclusion criteria: (a) having diabetes mellitus; (b) having immunodeficiency disorder; (c) history of using antibiotic, immunosuppressive drugs, radiotherapy, steroid, or antifungal drugs; (d) being simultaneously affected with other oral diseases such as gingivitis or periodontitis.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This is a before after trial without randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
D/P/16/35/9/1543
Health conditions studied
1
Description of health condition studied
Denture stomatitis
ICD-10 code
K12.1
ICD-10 code description
Other forms of stomatitis
Primary outcomes
1
Description
Salivary level of IL-10
Timepoint
Before treatment and 14 days after treatment
Method of measurement
Laboratory test
2
Description
Salivary level of TNF-α
Timepoint
Before treatment and 14 days after treatment
Method of measurement
Laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Treatment with Nystatin 100,000 U three times a day for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Masoud Rashizadeh
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
School of Dentistry
Full name of responsible person
Dr Masoud Rashizadeh
Position
Resident of Dentistry
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
rashidzadeh2007@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Poorandokht Davodi
Position
Specialist in Oral Diseases
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
p.davodi@umsha.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)