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Comparison of ginger and nystatin mouthwashes on denture stomatitis

Protocol summary

Summary
Denture stomatitis is a chronic inflammation of mucous membrane supporting the movable prostheses. This inflammation is accompanied with erythema, swelling of mucous membrane, and occasionally with pain and burning. The goal of this double blind clinical trial study is comparison of ginger and nystatin mouthwashes on denture stomatitis, that will carry on 30 patients with erythematous denture stomatitis. Duration of study is 20 days and patients after filling an informed consent form and demographic form, will be randomly assigned to two groups. Group one will be presented ginger mouthwash, produced by Rozhin Company (Tabriz, Iran) and the second group will be presented nystatin mouthwash, produced by Jabir ibn hayyan pharmaceutical company (Tehran, Iran). Since the method is carried out in a double- blind. Ginger and nystatin mouthwash bottles are identical and indistinguishable by the researcher and offering the mouth of the subjects can be done by a doctor other than researcher. Each person must use mouth washes 4 times daily, each time 20 drops For 60 seconds. Patients were requested to wear their dentures after the application of mouthwash and avoid eating for a half hour. The length and width of the erythema will be measured and recorded in the profile of each case, by the examiner during the meetings at days 0, 5 , 10 , 15 , 20 of the study and the data Will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014011616246N1
Registration date: 2015-01-17, 1393/10/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-17, 1393/10/27
Registrant information
Name
Hossein Eslami
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 41 1327 0408
Email address
eslamih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ginger and nystatin mouthwashes on denture stomatitis
Public title
Comparison of ginger and nystatin mouthwashes on denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 . Erythematose denture stomatitis patients. 2 . Willingness to participate in the study. 3 . Masticatory muscle health.(on The clinical examination of the masticatory muscles , tenderness and trismus Should not be seen). 4 . The ability to use mouthwash. 5 . Mental health. 6 . Denture fit(no signs of loose discoloration ) Exclusion criteria : 1 . A history of using antifungal drugs, antibiotics, and corticosteroid within the previous month. 2 . Allergy to ginger and nystatin mouthwashes. 3 . Alzheimer’s disease. 4 . Unwillingness to participate in the study. 5 . People with neuromuscular diseases who have no ability to oral hygiene. 6 . people with pinpoint and granular denture stomatitis 7 .People who are not qualified to give personal satisfaction (Such as children and people with mental disabilities).
Age
From 30 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of tabriz university of medical science
Street address
Central Building Vice Chancellor for Research-Vice Chancellor for Research and Technology
City
tabriz
Postal code
Approval date
2014-12-29, 1393/10/08
Ethics committee reference number
93147

Health conditions studied

1

Description of health condition studied
denture stomatitis
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis Oral thrush

Primary outcomes

1

Description
The length of erythem
Timepoint
On days: 0 ,5 ,10 ,15 ,20 of study
Method of measurement
Digital dial caliper, in hundredths of a millimeter

Secondary outcomes

1

Description
The width of erythem
Timepoint
On days: 0 ,5 ,15 ,20 of study
Method of measurement
Digital dial caliper, in hundredths of a millimeter

Intervention groups

1

Description
Intervention group: the members of this group (15 people) will be presented ginger mouthwash, produced by Rozhin Company (Tabriz, Iran). Each person must use mouth washes 4 times daily, each time 20 drops For 60 seconds. Patients were requested to wear their dentures after the application of mouthwash and avoid eating for a half hour. Patient Recommended using drug at a certain time.
Category
Treatment - Drugs

2

Description
Control group: the members of this group (15 people) will be presented nystatin mouthwash, produced by Jabir Ibn Hayyan pharmaceutical Company (Tehran, Iran). Each person must use mouth washes 4 times daily, each time 20 drops For 60 seconds. Patients were requested to wear their dentures after the application of mouthwash and avoid eating for a half hour. Patient Recommended using drug at a certain time.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Oral Medicine, Dental School, Tabriz
Full name of responsible person
Dr. Hossein Eslami,Assistant Professor
Street address
Faculty of Dentistry , Tabriz university of medical science
City
tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research
Full name of responsible person
Dr. Saied Rahimi
Street address
Tabriz Faculty of Dentistry
City
Tabriz
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
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
Tabriz Dental College
Full name of responsible person
Dr. Hosein Eslami
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental College, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
+98 41 3334 6877
Email
eslamih@tbzmed.ac.ir; aylinpakroo@yahoo.com; pakroo.solmaz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz Dental College
Full name of responsible person
Dr. Hosein Eslami
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental College, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 5965
Fax
+98 41 3334 6877
Email
eslamih@tbzmed.ac.ir; aylinpakroo@yahoo.com; pakroo.solmaz@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Dental College
Full name of responsible person
Solmaz Pakroo
Position
Student of Medicine
Other areas of specialty/work
Street address
Dental College, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3553 6716
Fax
Email
aylinpakroo@yahoo.com; pakro.solmaz@gmail.com
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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