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

NCT ID: NCT06884787

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Composite Resins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth study design, patients will be assigned to two different treatment protocols.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double (Participant, Outcomes Assessor) The patients who participated in the study and the assessor of the treatment outcome do not know the type of treatment procedure received.

Study Groups

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Control group (Conventional RBC)

Group 1 (n=120) teeth will be restored using conventional multi shade nanohybrid RBC (filtek Z350Xt,3M ESPE, San Paul, MN, USA)

Group Type EXPERIMENTAL

Conventional nanohybrid multishade composite

Intervention Type DRUG

Teeth will be restored with conventional multi shade nanohybrid Resin Based Composite (RBC) filtek Z350Xt,3M ESPE, San Paul, MN, USA

Test group (RBC with CAP)

Group 2 (n=120) teeth will be restored using Omnichroma (single shade) composite with color adjustment postential (CAP). (Omnichroma, Tokuyama Dental, Tokio, Japan)

Group Type EXPERIMENTAL

Single shade nanohybrid composite

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Single shade nanohybrid composite

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

Intervention Type DRUG

Other Intervention Names

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Conventional resin based composite (RBC) RBC with color adjustment potential (CAP)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdullah University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zakereyya SM Albashaireh, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

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Jordan University of Science and Technology

Irbid, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Zakereyya SM Albashaireh, Ph.D

Role: CONTACT

0791015505

Facility Contacts

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Zakereyya Albashaireh, PhD

Role: primary

0791015505

References

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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.

Reference Type BACKGROUND
PMID: 38378771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30524930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37999014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37132724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39125196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36398065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33354867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37821366 (View on PubMed)

Cruz da Silva ET, Charamba Leal CF, Miranda SB, Evangelista Santos M, Saeger Meireles S, Maciel de Andrade AK, Japiassu Resende Montes MA. Evaluation of Single-Shade Composite Resin Color Matching on Extracted Human Teeth. ScientificWorldJournal. 2023 Jun 26;2023:4376545. doi: 10.1155/2023/4376545. eCollection 2023.

Reference Type BACKGROUND
PMID: 37404241 (View on PubMed)

Rohym S, Tawfeek HEM, Kamh R. Effect of coffee on color stability and surface roughness of newly introduced single shade resin composite materials. BMC Oral Health. 2023 Apr 22;23(1):236. doi: 10.1186/s12903-023-02942-y.

Reference Type BACKGROUND
PMID: 37087507 (View on PubMed)

Zulekha, Vinay C, Uloopi KS, RojaRamya KS, Penmatsa C, Ramesh MV. Clinical performance of one shade universal composite resin and nanohybrid composite resin as full coronal esthetic restorations in primary maxillary incisors: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2022 Apr-Jun;40(2):159-164. doi: 10.4103/jisppd.jisppd_151_22.

Reference Type BACKGROUND
PMID: 35859408 (View on PubMed)

Miranda AO, Favoreto MW, Matos TP, Castro AS, Kunz P, Souza JL, Carvalho P, Reis A, Loguercio AD. Color Match of a Universal-shade Composite Resin for Restoration of Non-carious Cervical Lesions: An Equivalence Randomized Clinical Trial. Oper Dent. 2024 Jan 1;49(1):20-33. doi: 10.2341/23-021-C.

Reference Type BACKGROUND
PMID: 38057996 (View on PubMed)

Other Identifiers

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20250094

Identifier Type: -

Identifier Source: org_study_id

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