RecruitingNot ApplicableNCT06884813

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


Sponsor

King Abdullah University Hospital

Enrollment

120 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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.

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Interventions

DRUGConventional 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)

DRUGSingle 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)


Locations(1)

Jordan University of Science and Technology

Irbid, Jordan

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NCT06884813


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