Clinical trial NCT06884787: Color Adjusting Resin Composite in Anterior Tooth Restorations: Clinical and Subjective Evaluations
Official title: Clinical and Subjective Evaluations of a Universal-Shade, Color Adjusting Resin Composite in Anterior Tooth Restorations: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Composite Resins
Keywords: Single-sahde composite
Color adaptability,
Objective and subjective analysis
anterior restorations
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth study design, patients will be assigned to two different treatment protocols.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Color measurements using digital spectrophotometer VITA Easyshade V.
timeFrame: 1 year
measure: Subjective or Patient satisfaction
timeFrame: 1 year
measure: Objective or dentists satisfaction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Zakereyya SM Albashaireh, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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