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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Abdullah University Hospital

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Teeth with enamel or dentin deformations.

Teeth affected by fluorosis or tetracycline staining.

Teeth with severe discoloration.

Primary teeth.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Single shade nanohybrid composite

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control group (Conventional RBC)Experimental treatment 1 intervention
Group B: Test group (RBC with CAP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Color measurements using digital spectrophotometer VITA Easyshade V.

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.

Time frame
1 year
2

Subjective or Patient satisfaction

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.

Time frame
1 year
3

Objective or dentists satisfaction

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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