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NCT Number: NCT06884787

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

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.

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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 Albashaireh, PhD

CONTACT

[email protected]

0791015505

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Conventional nanohybrid multishade composite

Drug

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)

Single shade nanohybrid composite

Drug

Teeth will be restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan)

Other names: RBC with color adjustment potential (CAP)

Primary outcomes

  1. 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:

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

  2. 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.

  3. 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.

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

Important dates

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