Color Adjusting Resin Composite in Anterior Tooth Restorations: Clinical and Subjective Evaluations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional nanohybrid multishade composite, Single shade nanohybrid composite.
- Who it may be relevant to
- Registry conditions: Composite Resins. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Subjective Evaluations of a Universal-Shade, Color Adjusting Resin Composite in Anterior Tooth Restorations: A Randomized Controlled Trial
Overview
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.
Interventions
- 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 - Drug Single shade nanohybrid composite
Teeth will be restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan)
Primary outcome measures
- Color measurements using digital spectrophotometer VITA Easyshade V. [Time frame: 1 year]
- Subjective or Patient satisfaction [Time frame: 1 year]
- Objective or dentists satisfaction [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- Jordan University of Science and Technology — Irbid
Publications
- Anwar RS, Hussein YF, Riad M. Optical behavior and marginal discoloration of a single shade resin composite with a chameleon effect: a randomized controlled clinical trial. BDJ Open. 2024 Feb 20;10(1):11. doi: 10.1038/s41405-024-00184-w. PMID 38378771
- Blum IR, Ozcan M. Reparative Dentistry: Possibilities and Limitations. Curr Oral Health Rep. 2018;5(4):264-269. doi: 10.1007/s40496-018-0191-1. Epub 2018 Sep 15. PMID 30524930
- Rashid F, Farook TH, Dudley J. Digital Shade Matching in Dentistry: A Systematic Review. Dent J (Basel). 2023 Oct 27;11(11):250. doi: 10.3390/dj11110250. PMID 37999014
- Barros MS, Silva PFD, Santana MLC, Braganca RMF, Faria-E-Silva AL. Background and surrounding colors affect the color blending of a single-shade composite. Braz Oral Res. 2023 Apr 28;37:e035. doi: 10.1590/1807-3107bor-2023.vol37.0035. eCollection 2023. PMID 37132724
- Leal CFC, Miranda SB, Alves Neto EL, Freitas K, de Sousa WV, Lins RBE, de Andrade AKM, Montes MAJR. Color Stability of Single-Shade Resin Composites in Direct Restorations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Polymers (Basel). 2024 Jul 30;16(15):2172. doi: 10.3390/polym16152172. PMID 39125196
- Ahmed MA, Jouhar R, Khurshid Z. Smart Monochromatic Composite: A Literature Review. Int J Dent. 2022 Nov 8;2022:2445394. doi: 10.1155/2022/2445394. eCollection 2022. PMID 36398065
- Korkut B, Turkmen C. Longevity of direct diastema closure and recontouring restorations with resin composites in maxillary anterior teeth: A 4-year clinical evaluation. J Esthet Restor Dent. 2021 Jun;33(4):590-604. doi: 10.1111/jerd.12697. Epub 2020 Dec 23. PMID 33354867
- Cubukcu I, Gundogdu I, Gul P. Color match analysis of single-shade and multi-shade composite resins using spectrophotometric and visual methods after bleaching. Dent Mater J. 2023 Nov 29;42(6):826-834. doi: 10.4012/dmj.2023-115. Epub 2023 Oct 12. PMID 37821366
Identifiers
NCT: NCT06884787 · 20250094