NCT06884813

Clinical Evaluation of Color-Adjusting Composite Resin Following In-Office Dental Bleaching

Clinical Evaluation of a Single-Shade, Color-Adjusting Composite Resin Following In-Office Dental Bleaching: A Randomized Clinical 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

One challenge faced by dental professionals is that, unlike natural tooth structure, composite restorations do not lighten when exposed to bleaching agents. As a result, functional restorations may need replacement after bleaching to match the newly whitened teeth. However, replacing a composite restoration can lead to unnecessary removal of tooth structure, potentially weakening the tooth and increasing its susceptibility to further iatrogenic damage. This study will investigate the ability of Omnichroma restorations to shade-match tooth structure after bleaching. The null hypotheses will be: 1. Single-shade RBC will not exhibit similar shade and optical behavior to conventional RBC across all anterior restorations following bleaching. 2. Patient satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used. 3. Dentist satisfaction regarding color blending between the restoration and tooth structure will not differ according to the type of material used.

Detailed description

Selecting the proper shade for a restoration is of vital importance for achieving optimal aesthetic results. However, shade selection can be time-consuming, somewhat subjective, and heavily reliant on the clinician's visual judgement. This study will explore the ability of Omnichroma restorations to shade match tooth structure after bleaching. Patients visiting the JUST dental clinics who have at least two anterior restorations (one Omnichroma restoration and one multi-shade nanohybrid composite restoration) will be recruited for this study. The calculated sample size for the study is 240 teeth. The shade and the L\*a\*b\* scores will be recorded using spectrophotometer prior to bleaching and after bleaching. Two blinded, calibrated dentists will independently evaluate the resulting shade outcomes and assess the degree of color match between the restorations and the adjacent teeth after bleaching. This assessment will be categorized as either match or no match. The patient's satisfaction will also be recorded two weeks after bleaching.

Conditions

• Composite Resins

Interventions

Type	Name	Description
DRUG	Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System	Teeth restored with conventional multi shade nanohybrid Resin Based Composite (RBC) Filtek Z350Xt (3M ESPE, San Paul, MN, USA) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)
DRUG	Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System	Teeth restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan) subjected to bleaching using Opalescence Boost 40% In-Office Tooth Whitening System (Ultradent, Utah, USA)

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2025-03-19
• Last updated: 2025-03-24

Locations

1 site across 1 country: Jordan