NCT06884787

Color Adjusting Resin Composite in Anterior Tooth Restorations: Clinical and Subjective Evaluations

Clinical and Subjective Evaluations of a Universal-Shade, Color Adjusting Resin Composite in Anterior Tooth Restorations: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: King Abdullah University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The ability of single-shade composite restorations to blend with adjacent tooth structure shades is called chameleon effect. This effect is enhanced using specially designed spherical particles in the composite material which will help diffuse light in a way that mimics the natural color and translucency of teeth making the restoration nearly imperceptible to the naked eye. The hypotheses of the investigation are as follow: * Single-shade RBC exhibits similar shade matching and optical behavior to conventional RBC across all anterior restorations. * Patient satisfaction regarding color blending between the restoration and tooth structure is comparable regardless of the type of material used. * Dentist satisfaction regarding color blending is similar for both single-shade RBC and conventional RBC materials.

Detailed description

Optimal shade matching in restorative dentistry is crucial for achieving aesthetic success, particularly in anterior restorations. This study aims to evaluate the shade-matching efficacy of single-shade resin-based composites (RBCs) in comparison to conventional multi-shade composite, using spectrophotometric analysis as an objective measurement tool. Additionally, the study assesses patient and clinician satisfactions with the color adaptability of single-shade composites across various restoration types, including Class V, III, IV, and diastema closures. A sample of 240 teeth will be selected based on strict inclusion criteria and divided into two groups: a test group receiving single-shade RBCs and a control group receiving multi-shade composite. Each patient will receive at least one restoration from each treatment group, ensuring balanced comparison within subjects. Satisfaction levels regarding color adaptability and aesthetic integration will be evaluated using a Visual Analogue Scale (VAS) one-week post-treatment. The double-blind design will be employed as it maintains blinding for both patients and evaluating clinicians regarding the materials used in each restoration.

Conditions

• Composite Resins

Interventions

Type	Name	Description
DRUG	Conventional nanohybrid multishade composite	Teeth will be restored with conventional multi shade nanohybrid Resin Based Composite (RBC) filtek Z350Xt,3M ESPE, San Paul, MN, USA
DRUG	Single shade nanohybrid composite	Teeth will be restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan)

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

1 site across 1 country: Jordan