Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Discoloration, Tooth
• Intervention / Treatment: Diagnostic test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)

Detailed Description

The color matching of both groups will be evaluated visually using modified USPH criteria

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sarah ahmed, master; Phone Number: 01015139628; Email: sarah.mohamed@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Exclusion Criteria:

• tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single shade universal resin composite (omnichroma) with blocker; (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.	Diagnostic test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker); (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.
Active Comparator: single shade universal resin composite(GC solare sculpt) with chameleon effect; 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.	Diagnostic test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker); (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: sarah ahmed, master, Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): September 5, 2022
• Primary Completion (Anticipated): October 5, 2022
• Study Completion (Anticipated): April 7, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration
• Other Study ID Numbers: OPR 14/3/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No