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Evaluation of antibacterial and antifungal properties of complete denture tissue conditioners with adding chitosan, silver and zinc oxide nanoparticles

Protocol summary

Study aim
The aim of this study was to evaluate the effects of adding chitosan, silver, and zinc oxide nanoparticles to tissue conditioner materials in patients with denture stomatitis.
Design
Clinical trial with a sample size of 6 patients in 7 parallel groups, without blindness
Settings and conduct
This study will be performed among patients referring to Tabriz Dental School. Patients will be randomly divided into two groups. In the first group, patients will receive conventional tissue conditioners (control group) and in the second to seventh groups, patients will receive tissue conditioners containing silver, zinc oxide and chitosans nanoparticles with a weight percentage of 0.675 and 1.25 and 2.5, and 5 and 10 And 20, respectively. Microbial culture (Candida albicans, Enterococcus faecalis, Pseudomonas aeruginosa, Streptococcus mutans) will be done before and after the intervention and will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with denture Stomatitis, Having a healthy denture without leaping and discoloration. Exclusion criteria: Use of anti-fungal drugs, antibiotics and corticosteroids in the past month, Allergy to silver, zinc or other drugs
Intervention groups
In the first group, conventional tissue conditioners (GC Corporation, Japan) were placed under the patient's prosthesis for 72 hours (control group) and in the second to seventh groups, respectively, tissue conditioners containing silver, zinc oxide and chitosan nanoparticles (GC Corporation, Japan) with a weight percent of 0.675 and 1.25, and 2.5, and 5, and 10 and 20 for 72 hours under the patient's prosthesis.
Main outcome variables
Colony count

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150628022951N9
Registration date: 2019-05-18, 1398/02/28
Registration timing: retrospective

Last update: 2019-05-18, 1398/02/28
Update count: 0
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
milad Ghanizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
milad.ghanizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of antibacterial and antifungal properties of complete denture tissue conditioners with adding chitosan, silver and zinc oxide nanoparticles
Public title
Antimicrobial effects of nanoparticles in complete prostheses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with denture Stomatitis Having a healthy denture without leaping and discoloration
Exclusion criteria:
Use of anti-fungal drugs, antibiotics and corticosteroids in the past month Allergy to silver, zinc or other drugs
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.TBZMED.REC.1397.474

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
Colony count
Timepoint
Pre-intervention, 72 hours after intervention
Method of measurement
Measurement of Microorganisms Growth Based on Turbidity with 600 nm Spectrophotometer

Secondary outcomes

empty

Intervention groups

1

Description
Control Group: Receiving common tissue conditioners (GC Corporation, Japan) under prosthesis for 72 hours
Category
Treatment - Drugs

2

Description
First intervention group: Receiving tissue conditioners containing silver, zinc oxide and chitosans nanoparticles (GC Corporation, Japan) with a weight percentage of 0.657 under prosthesis for 72 hours
Category
Treatment - Drugs

3

Description
Second intervention group: Receiving tissue conditioners containing silver, zinc oxide and chitosans nanoparticles (GC Corporation, Japan) with a weight percentage of 1.25 under prosthesis for 72 hours
Category
Treatment - Drugs

4

Description
Third intervention group: Receiving tissue conditioners containing silver, zinc oxide and chitosans nanoparticles (GC Corporation, Japan) with a weight percentage of 2.5 under prosthesis for 72 hours
Category
Treatment - Drugs

5

Description
Forth intervention group: Receiving tissue conditioners containing silver, zinc oxide and chitosans nanoparticles (GC Corporation, Japan) with a weight percentage of 5 under prosthesis for 72 hours
Category
Treatment - Drugs

6

Description
Fifth intervention group: Receiving tissue conditioners containing silver, zinc oxide and chitosans nanoparticles (GC Corporation, Japan) with a weight percentage of 10 under prosthesis for 72 hours
Category
Treatment - Drugs

7

Description
Sixth intervention group: Receiving tissue conditioners containing silver, zinc oxide and chitosans nanoparticles (GC Corporation, Japan) with a weight percentage of 20 under prosthesis for 72 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Dental Faculty
Full name of responsible person
Hamed Aghajanzadeh
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
hhaghajanzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Joyban
Street address
Tabriz University of Medical Sciences,Golgasht Avenue, Azadi Street,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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 Amin Mousavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 9680
Email
s_aminmosavi88@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Aghajanzadeh
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
hhaghajanzadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Aghajanzadeh
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
hhaghajanzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information of patients and data related to the outcomes of the study will be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Sharing data for meta-analysis
From where data/document is obtainable
Please contact Dr.Hamed Aghajanzadeh by e-mail: hhaghajanzadeh@gmail.com
What processes are involved for a request to access data/document
After ensuring that your claim is true, these data will be sent to you.
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