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NCT Number: NCT06884813

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

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.

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Key information

Conditions

Composite Resins

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 21110, Jordan

Location status: Recruiting

Location contact

Zakereyya SM Albashaireh, PhD

CONTACT

[email protected]

0791015505

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional nanohybrid multishade composite and hydrogen peroxide 40% in-Office Tooth Whitening System

Drug

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)

Other names: Conventional resin based composite (RBC) and Hydrogen perioxide 40%

Single shade nanohybrid composite and hydrogen peroxide 40% in-Office Tooth Whitening System

Drug

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)

Other names: RBC with color adjustment potential (CAP) and Hydrogen perioxide 40%

Primary outcomes

  1. Color measurements using digital spectrophotometer VITA Easyshade V.

    Time frame: One year

    The colour measurements will be taken at first session for each tooth in specific points as follow:

    One reading from middle part of tooth Three readings at three points around the restoration and 1 mm away from its margins.

    To give a chance for tooth rehydration and final color optimization, a new reading will be obtained from the middle portion of the restoration after one week.

    The color difference (∆E00) between the tooth structure around the restoration and the restoration itself will be calculated.

    The color difference (∆E00) between the tooth and restoration will be compared between the control and test groups.

    The final ΔE00 value itself has no physical unit. It is just a numerical representation of color difference.

  2. Subjective or Patient satisfaction

    Time frame: One year

    Patient satisfaction regarding color blending between the restoration and tooth surface will be recorded after one week using visual analogue scale (VAS).

    The scale is a horizontal line with 10 digits, where 0 (on the right) represents total dissatisfaction with color blending between the tooth and restoration, and 10 (on the left) indicates complete satisfaction.

    Patients will mark their satisfaction with the color matching and blending of the restoration on the VAS.

    Measurements will be categorized as follows:

    Poor: VAS values from 0 to 5 Good: VAS values from 5.1 to 10

  3. Objective or dentists satisfaction

    Time frame: One year

    Photographs of the restored teeth will be taken under a standardized setup using a Canon 250D DSLR camera, a Sigma 105 mm macro lens, and a Meike MK-14EXT TTL macro ring flash.

    The images will be evaluated by two calibrated dentists who are blinded to the restoration material. Blending with the tooth surface will be assessed using VAS, with the assessors marking their evaluation on the scale.

    Measurements will be divided according following criteria:

    Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.

Study contacts

Contact information is provided by the study sponsor or research team.

Zakereyya SM Albashaireh, Ph.D

CONTACT

[email protected]

0791015505

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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