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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05315518

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Discoloration, Tooth	Diagnostic Test: single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker)	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 5, 2022

Anticipated Primary Completion Date :

Oct 5, 2022

Anticipated Study Completion Date :

Apr 7, 2023

Arms and Interventions

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.

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)

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)

Outcome Measures

Primary Outcome Measures

shade matching [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: sarah ahmed, master, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

sarah ali mohamed ahmed, Master's degree student-faculty of dentistry, Cairo University

ClinicalTrials.gov Identifier:

NCT05315518

Other Study ID Numbers:

OPR 14/3/2022

First Posted:

Apr 7, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth Discoloration

Study Results

No Results Posted as of Jul 19, 2022