purpose of study:comparison effect of anti fungal therapy with Zataria Multi Flora and Nystatin in Denture stomatitis in Islamic Azad University of Tehran- school of Dentistry in 2017-2018
design of study: randomised, single blind, without placebo, single center
population of study:patients who refer to Oral Medicine department of school of Dentistry-Islamic Azad University of Tehran
Inclusion criteria:patients above 18; with Denture stomatitis; type 2 and 3
Exclusion criteria: patients with Renal disease; Liver disease; Thyroid disease; Diabete; Xerostomia ; hypo parathyroidism; pregnant ;breast feeding women; changes in immune system; chemotherapy; radiotherapy; patients who take antibiotics and anti fungal drugs within 4 weeks ago
28 patients
intervention : measurement of erythem and CFU of Candida Albicans before intervention. then dividing patients in 2 groups randomisly. one group take Nyststin and another group take Zataria Multi Flora. after treatment measuring erythem and CFU of Candida Albicans of palate again .
time of intervention :2 weeks
comparison of treatment result in 2 groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061834619N1
Registration date:2017-09-24, 1396/07/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-24, 1396/07/02
Registrant information
Name
Tarane Farrokhnia
Name of organization / entity
Azad Islamc University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
t_farrokhnia@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Azad Islamic University of Tehran- school of Dentistry/ private
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of anti fungal therapy with Zataria Multi Flora and Nystatin in the treatment of patients with Denture stomatitis type 2 and type 3
Public title
Comparing effect of anti fungal therapy with Zataria Multi Flora and Nystatin in treatment of fungous associated with removable prothesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients above 18; with Denture stomatitis type 2 and 3
Exclusion criteria: patients with Renal disease; Liver disease; Thyroid disease; Diabet; Xerostomia; hypoparathyroidism; pregnant; brest feeding women; changes in immune system; chemotherapy; radiotherapy; patients who take antibiotics and antifungal drugs within 4 weeks ago
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Tehran- school of Dentistry
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Postal code
1946853314
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,35
Health conditions studied
1
Description of health condition studied
Denture stomatitis
ICD-10 code
B37
ICD-10 code description
Candidiasis
Primary outcomes
1
Description
count of cloni
Timepoint
before intervention-2 weeks after intervention
Method of measurement
CFU with microbiological measurment
2
Description
erythem
Timepoint
before intervention-2 weeks after intervention
Method of measurement
mm2- with grid
Secondary outcomes
1
Description
how long use removable denture
Timepoint
before intervention
Method of measurement
years-question from patient
2
Description
type of Denture stomatitis
Timepoint
before intervention
Method of measurement
type 2,3- visual
3
Description
how clean the removable denture
Timepoint
before intervention
Method of measurement
water/brush/cleaning agent- question from patient
4
Description
freqency of cleaning removable denture
Timepoint
before intervention
Method of measurement
0/1/2/3 and more than 3 in week- question from patient
5
Description
remove of removable denture in night
Timepoint
before intervention
Method of measurement
yes/no -question from patient
Intervention groups
1
Description
intervention:
drug(Zataria Multi Flora drop-5 cc -4 times in day for 2 weeks- wash the mouth)
Category
Treatment - Drugs
2
Description
control :
standard drug(Nyststin suspension- 40 drops-4 times in day for 2 weeks- wash the mouth )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad Islamic University of Tehran-school of Dentistry-Oral Medicine department
Full name of responsible person
Elnaz Gonoodi(Oral Medicine assistant)
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
private/Azad Islamic University of Tehran-school of Dentistry
Full name of responsible person
Tarane Farrokhnia
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
private/Azad Islamic University of Tehran-school of Dentistry
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
Azad Islamic University of Tehran- school of Dentistry