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Evaluation the color match of two single shade resin composites; Charisma Diamond ONE and Charisma Topaz ONE in class five restorations and assessment of dentist and patient satisfaction

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History
# Registration date Revision Id
2 2023-06-10, 1402/03/20 271472
1 2023-06-03, 1402/03/13 266822
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  • General information

    30
    50
    28
    50
    empty
    The predicted and realized sample size is 50, which was entered incorrectly
    empty
    حجم نمونه پیش بینی شده و تحقق یافته 50 عدد است که اشتباه وارد شده بود

  • Intervention groups

    #1
    The use of Charisma Diamond ONE single shade composite from culzer company in class 5 restorations
    The use of Charisma Diamond ONE single shade composite from kulzer company in class 5 restorations
    استفاده از كامپوزيت تك شيد Charisma Diamond ONE از شركت culzer در ترميم هاي كلاس ٥
    استفاده از كامپوزيت تك شيد Charisma Diamond ONE از شركت kulzer در ترميم هاي كلاس ٥

  • Recruitment centers

    #1
    Name of recruitment center - English: Special Clinic of Mashhad Faculty of Dentistry
    Name of recruitment center - Persian: کلینیک ویژه دانشکده دندانپزشکی مشهد
    Full name of responsible person - English: Dr hamide mohammadipour
    Full name of responsible person - Persian: دكتر حميده محمدي پور
    Street address - English: Faculty of Dentistry , Vakil abad Blvd , Mashhad
    Street address - Persian: مشهد - ابتدای بلوار وکیل آباد، مقابل پارک ملت - دانشکده دندانپزشکی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177948959
    Phone: +98 51 3806 7100
    Fax: +98 51 3882 9500
    Email: Atiyemirzaei98@gmail.com
    Web page address: https://dentistry.mums.ac.ir/
    Name of recruitment center - English: Special Clinic of Mashhad Faculty of Dentistry
    Name of recruitment center - Persian: کلینیک ویژه دانشکده دندانپزشکی مشهد
    Full name of responsible person - English: Dr Hamide Mohammadipour
    Full name of responsible person - Persian: دكتر حميده محمدي پور
    Street address - English: Faculty of Dentistry , Vakil abad Blvd , Mashhad
    Street address - Persian: مشهد - ابتدای بلوار وکیل آباد، مقابل پارک ملت - دانشکده دندانپزشکی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177948959
    Phone: +98 51 3806 7100
    Fax: +98 51 3882 9500
    Email: mohammadipourh@mums.ac.ir
    Web page address: https://dentistry.mums.ac.ir/

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr hamide mohammadipour
    Full name of responsible person - Persian: دكتر حميده محمدي پور
    Street address - English: Faculty of Dentistry , Vakil abad Blvd , Mashhad
    Street address - Persian: مشهد - ابتدای بلوار وکیل آباد، مقابل پارک ملت - دانشکده دندانپزشکی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177948959
    Phone: +98 51 3806 7100
    Fax: +98 51 3882 9500
    Email: Atiyemirzaei98@gmail.com
    Web page address: https://dentistry.mums.ac.ir/

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Amir Moeintaghavi
    Full name of responsible person - Persian: دکتر امیر معین تقوی
    Street address - English: Faculty of Dentistry , Vakil abad Blvd , Mashhad
    Street address - Persian: مشهد - ابتدای بلوار وکیل آباد، مقابل پارک ملت - دانشکده دندانپزشکی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177948959
    Phone: +98 51 3806 7100
    Fax: +98 51 3882 9500
    Email: dnts.research@mums.ac.ir
    Web page address: https://dentistry.mums.ac.ir/

Protocol summary

Study aim
Evaluation the color match of two single shade resin composites; Charisma Diamond ONE and Charisma Topaz ONE
Design
Superiority clinical trial with control group( Charisma topaz One), with parallel groups, three-blind, simple randomization on 50 sample. For randomization The patient is asked to choose an envelope, among the 50 initial envelopes, for each tooth that represents the type of restoration material.
Settings and conduct
The color of the tooth is recorded once before restoration and then 24 hours after the restoration by a spectrophotometer and three color components a, b and l. Evaluation of the level of satisfaction of the dentist and the patient with the color matching is done using Likert scored criteria The location of the study is the special clinic of the Faculty of Dentistry of Mashhad. It is a three-blind study by blinding the patients, evaluators, and analysts.
Participants/Inclusion and exclusion criteria
Participants must be over 18 years of age; have no visible discoloration on their teeth; and have medium-sized cervical caries in the buccal surface of their teeth. Patients with systemic diseases; severe periodontal diseases; dry mouth; patients with high risk of decay; smoking; patients or people undergoing orthodontic treatment are excluded from the study. Also, teeth with previous restorations or a history of root canal treatment and teeth with periapical lesions will not be evaluated.
Intervention groups
Single shade resin composite; Charisma Diamond ONE
Main outcome variables
The color of tooth is recorded once before restoration and then 24 hours after the restoration by a spectrophotometer and three color components a, b and l. Evaluation of the level of satisfaction of the dentist and the patient with the color matching is done using Likert scored criteria.

General information

Reason for update
The predicted and realized sample size is 50, which was entered incorrectly
Acronym
IRCT registration information
IRCT registration number: IRCT20221024056284N1
Registration date: 2023-06-03, 1402/03/13
Registration timing: retrospective

Last update: 2023-07-15, 1402/04/24
Update count: 1
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Atiye Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3871 6272
Email address
atiyemirzaei98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
2023-01-21, 1401/11/01
Actual recruitment end date
2023-03-04, 1401/12/13
Trial completion date
2023-03-05, 1401/12/14
Scientific title
Evaluation the color match of two single shade resin composites; Charisma Diamond ONE and Charisma Topaz ONE in class five restorations and assessment of dentist and patient satisfaction
Public title
Evaluation the color match of two single shade resin composites; Charisma Diamond ONE and Charisma Topaz ONE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over the age of 18 y/o Do not have a significant color change on their teeth Have medium-sized cervical caries in the buccal surface
Exclusion criteria:
Patients with systemic disease Patients with Xerostomia Patients with high risk of decay Smoker patients Patients with orthodontic treatment Teeth with root canal treatment Teeth with periapical lesion Severe periodontal diseases Teeth with previous restorations
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 2
Tooth with class 5 caries
Actual sample size reached: 50
More than 1 sample in each individual
Actual sample size in each individual: 2
Tooth with class 5 caries
Randomization (investigator's opinion)
Randomized
Randomization description
The patient is asked to choose an envelope, among the 50 initial envelopes, for each tooth that represents the type of restoration material.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The samples are randomly divided into two groups. Teeth restoration is done by one person and color evaluation by two other people. The person who performs the restoration, the patient, the color evaluators of the restoration are blind, and the data analyzer is also blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Dentistry - Mashhad University of Medical Sciences
Street address
Faculty of Dentistry , Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1401.129

Health conditions studied

1

Description of health condition studied
Class 5 dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries

Primary outcomes

1

Description
Color on the red-green axis (a)
Timepoint
The color of tooth is measured before the intervention and the color of the restoration is measured 24 hours after the restoration
Method of measurement
Spectrophotometry

2

Description
Color on the yellow-blue axis (b)
Timepoint
The color of tooth is measured before the intervention and the color of the restoration is measured 24 hours after the restoration
Method of measurement
Spectrophotometry

3

Description
lightness value (L)
Timepoint
The color of tooth is measured before the intervention and the color of the restoration is measured 24 hours after the restoration
Method of measurement
Spectrophotometry

4

Description
Patient satisfaction level
Timepoint
24 hours after restoration
Method of measurement
Evaluation of patients' satisfaction with color matching of the restoration and tooth is done using a 5-point Likert scale.

5

Description
Dentist satisfaction level
Timepoint
24 hours after restoration
Method of measurement
The visual evaluation of the color matching of the restoration and the tooth is done by two trained observers based on the Likert scale.

Secondary outcomes

empty

Intervention groups

1

Description
The use of Charisma Diamond ONE single shade composite from kulzer company in class 5 restorations
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Special Clinic of Mashhad Faculty of Dentistry
Full name of responsible person
Dr Hamide Mohammadipour
Street address
Faculty of Dentistry , Vakil abad Blvd , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Fax
+98 51 3882 9500
Email
mohammadipourh@mums.ac.ir
Web page address
https://dentistry.mums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Amir Moeintaghavi
Street address
Faculty of Dentistry , Vakil abad Blvd , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Fax
+98 51 3882 9500
Email
dnts.research@mums.ac.ir
Web page address
https://dentistry.mums.ac.ir/
Grant name
Vice-Chancellor's Office for Research of Mashhad university of medical science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Mohammadipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry , Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Fax
+98 51 3882 9500
Email
mohammadipourh@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Mohammadipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Fax
+98 51 3882 9500
Email
mohammadipourh@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atiye Mirzaei
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Fax
+98 51 3882 9500
Email
atiyemirzaei98@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
Not applicable
Title and more details about the data/document
All data can be published after being unidentifiable and kept confidential.
When the data will become available and for how long
After publishing the results in the form of an article
To whom data/document is available
All researchers in the relevant fields
Under which criteria data/document could be used
Based on the law of the Ministry of Health in connection with clinical trial studies
From where data/document is obtainable
Vice-Chancellor's Office for Research of Mashhad university of medical science
What processes are involved for a request to access data/document
After the approval of the relevant official, the data will be provided to the researcher
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