Color Adjusting Resin Composite in Anterior Tooth Restorations: Clinical and Subjective Evaluations
NCT ID: NCT06884787
Last Updated: 2025-03-19
Study Results
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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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-03-10
2026-08-01
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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)
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
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)
Single shade nanohybrid composite
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
Single shade nanohybrid composite
Teeth will be restored with One-shade Resin Based Composite (Omnichroma, Tokuyama Dental, Tokio, Japan)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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King Abdullah University Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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20250094
Identifier Type: -
Identifier Source: org_study_id
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