Protocol summary
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Study aim
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Evaluation the color match of two single shade resin composites; Charisma Diamond ONE and Charisma Topaz ONE
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Single shade resin composite; Charisma Diamond ONE
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Main outcome variables
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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
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Reason for update
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The predicted and realized sample size is 50, which was entered incorrectly
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Acronym
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IRCT registration information
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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
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Registration date
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2023-06-03, 1402/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-21, 1401/11/01
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Expected recruitment end date
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2023-03-16, 1401/12/25
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Actual recruitment start date
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2023-01-21, 1401/11/01
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Actual recruitment end date
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2023-03-04, 1401/12/13
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Trial completion date
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2023-03-05, 1401/12/14
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Scientific title
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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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Public title
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Evaluation the color match of two single shade resin composites; Charisma Diamond ONE and Charisma Topaz ONE
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patient is asked to choose an envelope, among the 50 initial envelopes, for each tooth that represents the type of restoration material.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-01-21, 1401/11/01
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Ethics committee reference number
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IR.MUMS.DENTISTRY.REC.1401.129
Health conditions studied
1
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Description of health condition studied
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Class 5 dental caries
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ICD-10 code
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K02
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ICD-10 code description
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Dental caries
Primary outcomes
1
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Description
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Color on the red-green axis (a)
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Timepoint
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The color of tooth is measured before the intervention and the color of the restoration is measured 24 hours after the restoration
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Method of measurement
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Spectrophotometry
2
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Description
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Color on the yellow-blue axis (b)
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Timepoint
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The color of tooth is measured before the intervention and the color of the restoration is measured 24 hours after the restoration
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Method of measurement
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Spectrophotometry
3
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Description
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lightness value (L)
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Timepoint
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The color of tooth is measured before the intervention and the color of the restoration is measured 24 hours after the restoration
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Method of measurement
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Spectrophotometry
4
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Description
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Patient satisfaction level
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Timepoint
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24 hours after restoration
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Method of measurement
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Evaluation of patients' satisfaction with color matching of the restoration and tooth is done using a 5-point Likert scale.
5
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Description
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Dentist satisfaction level
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Timepoint
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24 hours after restoration
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Method of measurement
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The visual evaluation of the color matching of the restoration and the tooth is done by two trained observers based on the Likert scale.
Intervention groups
1
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Description
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The use of Charisma Diamond ONE single shade composite from kulzer company in class 5 restorations
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Vice-Chancellor's Office for Research of Mashhad university of medical science
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All data can be published after being unidentifiable and kept confidential.
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When the data will become available and for how long
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After publishing the results in the form of an article
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To whom data/document is available
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All researchers in the relevant fields
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Under which criteria data/document could be used
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Based on the law of the Ministry of Health in connection with clinical trial studies
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From where data/document is obtainable
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Vice-Chancellor's Office for Research of Mashhad university of medical science
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What processes are involved for a request to access data/document
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After the approval of the relevant official, the data will be provided to the researcher
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Comments
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