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

Not Applicable

Recruiting

• Conditions: Composite Resins
• Interventions: Drug: Conventional nanohybrid multishade composite; Drug: Single shade nanohybrid composite

• Registration Number: NCT06884787
• Lead Sponsor: King Abdullah University Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-10
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-05-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (Conventional RBC)	Conventional nanohybrid multishade composite	Group 1 (n=120) teeth will be restored using conventional multi shade nanohybrid RBC (filtek Z350Xt,3M ESPE, San Paul, MN, USA)
Test group (RBC with CAP)	Single shade nanohybrid composite	Group 2 (n=120) teeth will be restored using Omnichroma (single shade) composite with color adjustment postential (CAP). (Omnichroma, Tokuyama Dental, Tokio, Japan)

Primary Outcome Measures

Name	Time	Method
Objective or dentists satisfaction	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.
Color measurements using digital spectrophotometer VITA Easyshade V.	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.
Subjective or Patient satisfaction	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.

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan