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Assessment of adherence, oral tissue sensivity and satisfaction level of patients using Rozhin and Corega company`s denture adhesives

Protocol summary

Study aim
Assessment of adherence,oral tissue sensivity and satisfaction level of patients using Rozhin and Corega company`s denture adhesives
Design
Clinical trials,with parallel groups,Triple-blinded with randomized sampling among Individuals referring to the Tabriz Dental faculty.The patients,evaluator and student are not aware of the type of adhesive.By statistical analysis,the sample size will include 52 people that will divided two groups(n = 26)of the recipients of Rojin glue and Corega adhesives.Patients are taught how to use the denture adhesives. In this way, the patient attaches the amount written on the product to three parts of the denture away from the edges,once a day.After 24hr ,3,7and 30 days will be followed.Patient is examined for tissue sensitivity, taste and smell of the adhesive,ability to clean and level of satisfaction.
Settings and conduct
52 number of patients divided into two Groups:adhesives of Rojin and Corega. After 24hr ,3,7and 30 days will be followed.Patient is examined for tissue sensitivity, taste and smell of the adhesive,ability to clean and level of satisfaction.The patients, evaluator and student are not aware of the type of adhesive
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with grade 3 and 4 of the Periodontal Disease Index(PDI).Adaptable Denture.Use of denture for maximum of 5years Exclusion criteria:Patients with oral ulcers or lesions,history of allergies,severe xerostomia
Intervention groups
1:Rojin's denture adhesives 2:Corega's denture adhesives
Main outcome variables
Tissue sensitivity, taste and smell of adhesive, cleaning ability , adhesion and satisfaction of patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200218046544N1
Registration date: 2020-04-10, 1399/01/22
Registration timing: registered_while_recruiting

Last update: 2020-04-10, 1399/01/22
Update count: 0
Registration date
2020-04-10, 1399/01/22
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
2020-04-04, 1399/01/16
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of adherence, oral tissue sensivity and satisfaction level of patients using Rozhin and Corega company`s denture adhesives
Public title
Evaluate the quality of Rozhin and Corega company`s denture adhesives
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Using of artificial dentures Satisfaction to participate in the study Patients with grade 3 and 4 of the Periodontal Disease Index(PDI) Adaptable Denture Use of denture for maximum of 5 years
Exclusion criteria:
severe xerostomia Patients with oral ulcers History of allergies Having red or white oral lesions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling Method is randomly Available among Individuals referring to The Department of Prosthodontics of Tabriz Dental faculty. The randomization Method is simple and the Unit is individual, our Tool for randomization is the randomized Number Chart. Furthermore, the Allocation of adhesives to Patients is done Randomly. To do this, the two types of adhesives are randomly recorded by a non-partner by numbering the numbers one to 52 and placed in tubes that are exactly the same shape and size. Then it is placed in a bag and stirred. Then, a tube is randomly removed from bag and used for each patient. None of the patients are aware of their adhesive type and the other patient. The evaluator, the student, and the principal are not aware of the type of adhesive .
Blinding (investigator's opinion)
Triple blinded
Blinding description
The present study is triple-blinded. None of the patients are aware of the type of their adhesive and the other patient. The evaluator, the student, and the principal investigator are not aware of the type of adhesive
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
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.TBZMED.REC.1398.1123

Health conditions studied

1

Description of health condition studied
Prosthodontic
ICD-10 code
Fitting an
ICD-10 code description
Z46.3

Primary outcomes

1

Description
The Intensity of tissue sensitivity
Timepoint
After 24 hours,three days,one week and one month
Method of measurement
Measurement of tissue sensitivity based on three criteria including of oral irritation, erythema or ulcer

2

Description
Taste and smell of adhesive
Timepoint
After 24 hours,three days,one week and one month
Method of measurement
According to the questionnaire

3

Description
Cleaning ability
Timepoint
After 24 hours,three days,one week and one month
Method of measurement
According to the questionnaire from 1 to 10

4

Description
Satisfaction
Timepoint
After 24 hours,three days,one week and one month
Method of measurement
According to the questionnaire from 1 to 10

5

Description
The amount of adhesion
Timepoint
After 24 hours,three days,one week and one month
Method of measurement
According to the questionnaire from 1 to 10

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Patients are taught how to use Rojin Company . (Rojin Pharmaceutical Health Company, Tabriz)denture adhesive. In this way, the patient attaches the amount written on the product to three parts of the denture away from the edges,once a day.
Category
Treatment - Drugs

2

Description
Intervention Group 2: Patients are taught how to use Corega(GlaxoSmithKline Co, Ireland)denture adhesive. In this way, the patient attaches the amount written on the product to three parts of the denture away from the edges,once a day
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
Building No.2, Dental Faculty, 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
Dr.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
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.Vahid Fakhrzadeh
Position
Assistant professor of Prosthodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Building No.2, Dental Faculty, 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
Building No.2, Dental Faculty, 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
Building No.2, Dental Faculty, 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
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