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

NCT05315518 | Unknown

• 1 other identifier: OPR 14/3/2022
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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

Conditions

Discoloration, Tooth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

single shade universal resin composite (omnichroma) with blocker

EXPERIMENTAL

(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)

single shade universal resin composite(GC solare sculpt) with chameleon effect

ACTIVE COMPARATOR

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)

Interventions

single-shade universal resin composite (omnichroma) with blocker( omnichroma blocker) DIAGNOSTIC_TEST

(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.

single shade universal resin composite (omnichroma) with blocker; single shade universal resin composite(GC solare sculpt) with chameleon effect

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• sarah ahmed, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sarah ahmed, master

CONTACT

01015139628; sarah.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree student-faculty of dentistry

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 7, 2022
• Study Start: September 5, 2022
• Primary Completion: October 5, 2022
• Study Completion: April 7, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The restorations will be evaluated at T1= after 1 week T2= 3months T3= 6 months T4= 12 months
• 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