Comparative effects of matrica extract and Nystatin mouthwash on erytemarous denture osteomatitis
Design
The clinical trial with the parallel intervention group is one-way, blind, randomized. Our randomization method is simple and our tool for randomization is a random number table. The 22 people will be divided into two groups. The first group will receive matrica mouthwash and the second group will receive nystatin for 20 days. Then the length and width of the erythema in the two groups will be determined and compared in 5-10-15-20 days.
Settings and conduct
Individuals referring to the Oral Diseases Department of the Faculty of Dentistry, University of Tabriz, who suffer from denture stomatitis erythematosus will be selected. The individuals will be divided into two groups and randomly placed in one group. The first group will receive barrage essential oil matrica mouthwash for 20 days and 20 drops three times a day, and the second group will receive nistanin mouthwash according to the conditions of the first group.Participants are not aware of the type of mouthwash.
Participants/Inclusion and exclusion criteria
Entrance criteria: Having denture stomatitis erythematosus , suitable tooth , Mental health
Exit criteria: Use of antifungal drugs , antibiotics and corticosteroids in past month, allergy to matrica, Alzheimer's disease, people with neuromuscular diseases, Having granular pin point denture stomatitis, Having mental disabilities, Diabetic patients, Smoking patients
Intervention groups
The 22 people will be divided into two groups. The first group will receive matrica mouthwash and the second group will receive nystatin mouthwash for 20 days.
Main outcome variables
The length of erythema after use of matrica extract and nystatin in 5-10-15-20 days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200218046544N2
Registration date:2020-09-05, 1399/06/15
Registration timing:registered_while_recruiting
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Vahid Fakhrzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
fakhrzadehv@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of matrica extract and Nystatin mouthwash on erytematous denture osteomatitis
Public title
Comparative effects of matrica extract and Nystatin mouthwash on erytematous denture osteomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having denture stomatitis erythematosus
Willingness to participate in the study
Ability to use mouthwash
Suitable tooth (healthy without looseness and discoloration)
Mental health
Exclusion criteria:
Use of antifungal drugs
Antibiotics and corticosteroids in past month
Allergy to matrica
Alzheimer's disease
people with neuromuscular diseases
Having granular pin point denture stomatitis
Having mental disabilities
Diabetic patients
Smoking patients
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling method is available among people referring to the Department of Prosthodontics, Tabriz Dental School. The method of randomization is simple and its unit is individual. Our tool is to randomize the table of random numbers. Assignment of mouthwash to patients is also done randomly. In this way, two types of mouthwash were recorded by numbering numbers one and two, then the numbers were placed in a bag and stirred, then one number was randomly taken out of the bag for each patient and the mouthwash was given to them according to the desired number. Neither patient will be informed of their own type of mouthwash and that of another patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the patients are aware of the existence of two types of mouthwash, nor are they aware of their own type of mouthwash and that of another patient.
Placebo
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 Sciences
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.TBZMED.REC.1399.408
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
The length of erythema
Timepoint
Before starting the use of mouthwash (day=0) and 5, 10, 15, 20 days after starting the mouthwash
Method of measurement
It will be measured by a digital calibrated caliper (made in Germany) and recorded in hundredths of a millimeter.
Secondary outcomes
1
Description
Width of erythema
Timepoint
Before starting the use of mouthwash(day= zero) and 5, 10, 15, 20 days after using
Method of measurement
It will be measured by a digital calibrated caliper (made in Germany) and recorded in hundredths of a millimeter.
Intervention groups
1
Description
Intervention group1: 11 people in this group are prescribed matrica mouthwash and the patient will be told to rinse 20 drops of the drug 3 times a day, once every 8 hours and each time for 60 seconds. After each use of mouthwash, put the denture in your mouth and avoid eating and drinking for 30 minutes.
Category
Treatment - Drugs
2
Description
Intervention group2: People in this group will be prescribed nystatin mouthwash produced by Jaber Binuhian Pharmaceutical Company (Tehran, Iran). Slowly After each use of mouthwash, put the denture in your mouth and avoid eating and drinking for 30 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, Dentistry Faculty, Department of Prosthodontics
Full name of responsible person
Dr Vahid Fakhrzadeh
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
v.fakhrzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad samiei
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
v.fakhrzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahid Fakhrzadeh
Position
Assistant professor of Prosthodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
v.fakhrzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahid Fakhrzadeh
Position
Assistant professor of Prosthodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
v.fakhrzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahid Fakhrzadeh
Position
Assistant professor of Prosthodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
v.fakhrzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available