Color Adjusting Resin Composite in Anterior Tooth Restorations: Clinical and Subjective Evaluations

March 18, 2025 updated by: King Abdullah University Hospital

Clinical and Subjective Evaluations of a Universal-Shade, Color Adjusting Resin Composite in Anterior Tooth Restorations: A Randomized Controlled Trial

The ability of single-shade composite restorations to blend with adjacent tooth structure shades is called chameleon effect. This effect is enhanced using specially designed spherical particles in the composite material which will help diffuse light in a way that mimics the natural color and translucency of teeth making the restoration nearly imperceptible to the naked eye.

The hypotheses of the investigation are as follow:

  • Single-shade RBC exhibits similar shade matching and optical behavior to conventional RBC across all anterior restorations.
  • Patient satisfaction regarding color blending between the restoration and tooth structure is comparable regardless of the type of material used.
  • Dentist satisfaction regarding color blending is similar for both single-shade RBC and conventional RBC materials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Optimal shade matching in restorative dentistry is crucial for achieving aesthetic success, particularly in anterior restorations. This study aims to evaluate the shade-matching efficacy of single-shade resin-based composites (RBCs) in comparison to conventional multi-shade composite, using spectrophotometric analysis as an objective measurement tool. Additionally, the study assesses patient and clinician satisfactions with the color adaptability of single-shade composites across various restoration types, including Class V, III, IV, and diastema closures.

A sample of 240 teeth will be selected based on strict inclusion criteria and divided into two groups: a test group receiving single-shade RBCs and a control group receiving multi-shade composite. Each patient will receive at least one restoration from each treatment group, ensuring balanced comparison within subjects. Satisfaction levels regarding color adaptability and aesthetic integration will be evaluated using a Visual Analogue Scale (VAS) one-week post-treatment. The double-blind design will be employed as it maintains blinding for both patients and evaluating clinicians regarding the materials used in each restoration.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
      • Irbid, Jordan, 21110
        • Recruiting
        • Jordan University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients attending the dental clinics at JUST in Irbid or on the university campus.
  • Patients aged 18 years and older.
  • Patients with good oral hygiene.
  • Patients with a positive attitude towards dental treatment.
  • Patients require restorations on at least two anterior teeth.
  • Patients with spaces between teeth that do not require orthodontic treatment for correction.
  • Patients with healthy pulp or reversible pulpitis.
  • Patients without any periapical lesions

Exclusion Criteria:

  • Teeth with enamel or dentin deformations.
  • Teeth affected by fluorosis or tetracycline staining.
  • Teeth with severe discoloration.
  • Primary teeth.
  • Patients with gingival inflammation or periodontal disease.
  • Patients undergoing active orthodontic treatment.
  • Heavy smokers.
  • Very deep or very shallow cavities.
  • Class IV cavities where more than half of the tooth surface is lost.
  • Traumatic Class IV cavities with pulp exposure.
  • Class III cavities that do not open labially.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group (Conventional RBC)
Group 1 (n=120) teeth will be restored using conventional multi shade nanohybrid RBC (filtek Z350Xt,3M ESPE, San Paul, MN, USA)
Drug: Conventional nanohybrid multishade composite
Teeth will be restored with conventional multi shade nanohybrid Resin Based Composite (RBC) filtek Z350Xt,3M ESPE, San Paul, MN, USA
Other Names:
  • Conventional resin based composite (RBC)
Experimental: Test group (RBC with CAP)
Group 2 (n=120) teeth will be restored using Omnichroma (single shade) composite with color adjustment postential (CAP). (Omnichroma, Tokuyama Dental, Tokio, Japan)
Drug: Single shade nanohybrid composite
Teeth will be restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan)
Other Names:
  • RBC with color adjustment potential (CAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color measurements using digital spectrophotometer VITA Easyshade V.
Time Frame: 1 year

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

  1. One reading from middle part of tooth
  2. Three readings at three points around the restoration and 1 mm away from its margins.
  3. After one week and to give a chance for tooth rehydration and final color optimization a new reading will be obtained from the middle portion of the restoration.

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

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

The final ΔE00 value itself has no physical unit-it is just a numerical representation of color difference.
1 year
Subjective or Patient satisfaction
Time Frame: 1 year

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

The scale is a horizontal line having 10 digits. Digit 0 starting from the right indicates total dissatisfaction regarding color blending between tooth and restoration and digit 10 indicates complete satisfaction.

Patients will be asked to draw a line on VAS that represents their satisfaction regarding color matching and blending of the restoration.

Measurements will be divided according following criteria:

Poor: VAS values ranging from 0-5. Good :VAS values ranging from 5.1-10.
1 year
Objective or dentists satisfaction
Time Frame: 1 year

Photographs of the restored teeth will be taken under standard setup using Canon 250DSLR camera, Sigma 105 mm Macro lens and Meike MK-14EXT TTL Macro Ring Flash.

The pictures will be assessed by two calibrated dentists who did not know the restoration material being assessed. Blending with tooth surface will be done using VAS and the assessors will draw a line VAS.

Measurements will be divided according following criteria:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Investigators

  • Principal Investigator: Zakereyya SM Albashaireh, Ph.D, Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20250094 (Other Identifier: Guangdong Provincial Maternal and Child Health Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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