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

Official title

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

Overview

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.

Interventions

• 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)

Primary outcome measures

• Color measurements using digital spectrophotometer VITA Easyshade V. [Time frame: One year]
• Subjective or Patient satisfaction [Time frame: One year]
• Objective or dentists satisfaction [Time frame: One year]

Eligibility criteria

Inclusion criteria

• Patients who are willing to come back for follow-up appointments.
• Patients who are willing to sign an informed consent form.
• Patients with well documented clinical records and have at least two anterior restorations (both Omnichroma and conventional multi-shade nanohybrid composite.)
• Patients aged 18 years or older.
• Patients with good oral hygiene
• Patients with vital teeth.
• Patients who are willing to have the restorations replaced later if necessary if there is a color mismatch after bleaching treatment.

Exclusion criteria

• Individuals with severe bruxism or periodontal disease.
• Patients with non-vital teeth restored with composite fillings.
• Patients with severe tooth discoloration.
• Patients with fluorosis or tetracycline staining.
• Heavy smokers.
• Pregnant or nursing women.
• Patients undergoing orthodontic treatment.
• Patients with enamel or dentin deformations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Jordan · 1 center

• Jordan University of Science and Technology — Irbid

Publications

• Villarroel M, Fahl N, De Sousa AM, De Oliveira OB Jr. Direct esthetic restorations based on translucency and opacity of composite resins. J Esthet Restor Dent. 2011 Apr;23(2):73-87. doi: 10.1111/j.1708-8240.2010.00392.x. Epub 2011 Feb 25. PMID 21477031
• Hafez R, Ahmed D, Yousry M, El-Badrawy W, El-Mowafy O. Effect of in-office bleaching on color and surface roughness of composite restoratives. Eur J Dent. 2010 Apr;4(2):118-27. PMID 20396441
• Forabosco E, Consolo U, Mazzitelli C, Kaleci S, Generali L, Checchi V. Effect of bleaching on the color match of single-shade resin composites. J Oral Sci. 2023 Oct 1;65(4):232-236. doi: 10.2334/josnusd.23-0159. Epub 2023 Aug 3. PMID 37532526
• AlHabdan A, AlShamrani A, AlHumaidan R, AlFehaid A, Eisa S. Color Matching of Universal Shade Resin-Based Composite with Natural Teeth and Its Stability before and after In-Office Bleaching. Int J Biomater. 2022 Oct 26;2022:8420890. doi: 10.1155/2022/8420890. eCollection 2022. PMID 36341131

Identifiers

NCT: NCT06884813 · 20250033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗