Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

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.

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  1. Individuals with severe bruxism or periodontal disease.
  2. Patients with non-vital teeth restored with composite fillings.
  3. Patients with severe tooth discoloration.
  4. Patients with fluorosis or tetracycline staining.
  5. Heavy smokers.
  6. Pregnant or nursing women.
  7. Patients undergoing orthodontic treatment.
  8. Patients with enamel or dentin deformations.

Study details
    Composite Resins

NCT06884813

King Abdullah University Hospital

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.