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Effect of Zataria Multiflora (Shirazi Thyme) drop versus Nystatine drop on clinical signs and symptoms in patients with denture stomatitis: a triple blind randomized clinical trial

Protocol summary

Summary
Objectives: To assess the effect of Zataria Multiflora (Shirazi Thyme) drop versus Nystatine drop on clinical signs and symptoms in patients with denture stomatitis. Design: a triple blind randomized clinical trial. Setting and conduct: The eligible patients with denture stomatitis, who will refer to Department of Oral Diseases of the School of Dentistry, Hamadan University of Medical Sciences during the study period, will be enrolled into the trial. Inclusion criteria: (a) affected with denture stomatitis type 2 or 3 for at least 11 years; (b) age of 45 to 80 years. Exclusion criteria: (a) sensitivity to Zataria Multiflora or Nystatine; (b) pregnancy; (c) having anemia or malnutrition; (d) having liver disorder, renal diseases, diabetes, xerostomia, hypoparathyroidism, or immunodeficiency; (e) being treated with chemotherapy, antibiotic, or anti-fungal medications. Intervention group: Zataria Multiflora (Shirazi Thyme) drop 0.1%, 2.5 ml 4 times a day for 2 weeks. Control group: Nystatine drop 2.5 ml 4 times a day for 2 weeks. Primary outcome: Assessing the extent of the inflammation and the number of colonies on palate and mucosal surface of the denture stomatitis before treatment and 2, 3, 4 weeks after treatment through physical examination. Secondary outcome: Nothing.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507259014N72
Registration date: 2015-08-01, 1394/05/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-01, 1394/05/10
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
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zataria Multiflora (Shirazi Thyme) drop versus Nystatine drop on clinical signs and symptoms in patients with denture stomatitis: a triple blind randomized clinical trial
Public title
Effect of Zataria Multiflora (Shirazi Thyme) drop versus Nystatine drop on clinical signs and symptoms in patients with denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) affected with denture stomatitis type 2 or 3 for at least 11 years; (b) age of 45 to 80 years. Exclusion criteria: (a) sensitivity to Zataria Multiflora or Nystatine; (b) pregnancy; (c) having anemia or malnutrition; (d) having liver disorder, renal diseases, diabetes, xerostomia, hypoparathyroidism, or immunodeficiency; (e) being treated with chemotherapy, antibiotic, or anti-fungal medications.
Age
From 45 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups one at a time. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.

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
2015-04-11, 1394/01/22
Ethics committee reference number
IR.UMSHA.REC.1394.22

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
Assessing the extent of the inflammation and the number of colonies on palate and mucosal surface of the denture stomatitis
Timepoint
before treatment and 2, 3, 4 weeks after treatment
Method of measurement
through physical examination

Secondary outcomes

1

Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing

Intervention groups

1

Description
Zataria Multiflora (Shirazi Thyme) drop 0.1%, 2.5 ml 4 times a day for 2 weeks
Category
Treatment - Drugs

2

Description
Nystatine drop 2.5 ml 4 times a day for 2 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr Zahra Hayati
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 Zahra Hayati
Position
Resident of 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
zah.hayati@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Hamid Reza Abdolsamadi
Position
Oral Diseases Specialist
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
abdolsamadi@umsha.ac.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)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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