Back to resultsEffect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations
Primary Purpose
Discoloration, Tooth
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)
Sponsored by
About this trial
This is an interventional treatment trial for Discoloration, Tooth
Eligibility Criteria
Inclusion Criteria:
moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients
-
Exclusion Criteria:
- tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
single shade universal resin composite (omnichroma) with blocker
single shade universal resin composite(GC solare sculpt) with chameleon effect
Arm Description
(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.
One-shade universal resin composite (GC solare sculpt) gives very natural appearance, High gloss retention over time, time saving regarding to layering technique, wide shade matching range (chameleon effect) and delivering lifelike aesthetic restorations. These features can be offered by supra-nano spherical filler which have controlled refractive index, records excellent esthetic properties in small and medium class IV restorations.
Outcomes
Primary Outcome Measures
shade matching
the shade matching of both groups will be assessed visually by using modified USPH criteria.
score: 1- Alpha : the restoration match the shade and translucency of the adjacent tooth 2-Bravo : there is a mismatch in the shade and translucency but it is within a normal range of tooth shade 3- Charlie: the mismatch is beyond the normal range of the tooth shade and translucency
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05315518
Brief Title
Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations
Official Title
Effect of Using Shade Blocker Versus Chameleon Effect on Shade Matching of Two Single-shade Resin Composite Materials in Class IV Restorations: A One Year Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 5, 2022 (Anticipated)
Primary Completion Date
October 5, 2022 (Anticipated)
Study Completion Date
April 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class IV restorations over 1 year evaluation period
Detailed Description
The color matching of both groups will be evaluated visually using modified USPH criteria
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoloration, Tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single shade universal resin composite (omnichroma) with blocker
Arm Type
Experimental
Arm Description
(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.
Arm Title
single shade universal resin composite(GC solare sculpt) with chameleon effect
Arm Type
Active Comparator
Arm Description
One-shade universal resin composite (GC solare sculpt) gives very natural appearance, High gloss retention over time, time saving regarding to layering technique, wide shade matching range (chameleon effect) and delivering lifelike aesthetic restorations. These features can be offered by supra-nano spherical filler which have controlled refractive index, records excellent esthetic properties in small and medium class IV restorations.
Intervention Type
Diagnostic Test
Intervention Name(s)
single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)
Intervention Description
(OMNICHROMA BLOCKER) is indicated for preventing shade-matching interference in Class IV restorations, Masking dark dentition and dentin. In cases where there is a lack of tooth structure to bond to, (BLOCKER) works as a supplementary product to provide a lingual wall to the restoration, prevent shade-match obstruction and mask staining.
Primary Outcome Measure Information:
Title
shade matching
Description
the shade matching of both groups will be assessed visually by using modified USPH criteria.
score: 1- Alpha : the restoration match the shade and translucency of the adjacent tooth 2-Bravo : there is a mismatch in the shade and translucency but it is within a normal range of tooth shade 3- Charlie: the mismatch is beyond the normal range of the tooth shade and translucency
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients
-
Exclusion Criteria:
tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sarah ahmed, master
Phone
01015139628
Email
sarah.mohamed@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sarah ahmed, master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The aim of the study is to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade universal resin composite in class IV restorations over 1year evaluation period.
IPD Sharing Time Frame
The restorations will be evaluated at T1= after 1 week T2= 3months T3= 6 months T4= 12 months
IPD Sharing Access Criteria
Patients with class IV defects (due to caries lesions, trauma…etc.)
Young adult (20 : 40 years old)
Good oral hygiene
Co-operative patients approving to participate in the study
Learn more about this trial
Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations
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