Evaluation of 2-year Clinical Performance of Two Different Single Color Universal Composite Resin Restorative Materials.

NCT06125132 | Active Not Recruiting

• 1 other identifier: D-KA22/25
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Dentists have recently preferred to use composite materials and restorative techniques that allow the use of simplified clinical protocols in order to reduce the time the patient spends in the dentist's chair and minimize technical sensitivity. Color selection in the clinic is a very sensitive process and is affected by environmental factors and operator-related variables. This has led to the development of single-color universal composite resins that aim to facilitate color selection. These materials have a universal opacity and several Vita shades and are recommended by manufacturers to be used in a single color layer that can match different tooth colors. In recent years, monochromatic universal composites have been developed that are supposed to be compatible with all Vita Classic Scale shades from A1 to D4. Manufacturers report that single-color universal composites can be applied to teeth of all colors without using the layering technique using different color composites. Therefore, the aim of this study is to compare the clinical performance of 2 different single-color universal composite resin materials (OMNICHROMA and Zenchroma) in the restoration of non-carious cervical lesions with the control group (Filtek Z250, 3M), which is a multi-color composite resin material, using modified US Public Health Service (USPHS) and World Dental Federation (FDI) criteria.

Conditions

Tooth Discoloration; Tooth Wear

Keywords

one-shade composites; single-shade composites; universal composites

Outcome Measures

Primary Outcomes (1)

• Clinical performance according to the modified United States Public Health Service criteria

  Retention, marginal discoloration, marginal adaptation, secondary caries and postoperative sensitivity will be scored as Alpha (the best), Bravo (acceptable) and Charlie (unacceptable).

  6,12,18, 24 and 36 months

Secondary Outcomes (1)

• Clinical performance of restorations according to the World Dental Organization criteria

  6,12,18, 24 and 36 months

Study Arms (3)

OMNICHROMA one shade composite

ACTIVE COMPARATOR

a one-shade composite resin as experimental group

Procedure: Restoration with-tooth colored material

Zen Chroma one shade composite

ACTIVE COMPARATOR

a one-shade composite resin as experimental group

Procedure: Restoration with-tooth colored material

Filtek Z250 multi shade composite

ACTIVE COMPARATOR

a multi-shade composite resin as control group

Procedure: Restoration with-tooth colored material

Interventions

Restoration with-tooth colored material PROCEDURE

Restoration of abrasions with different composite resin materials

Filtek Z250 multi shade composite; OMNICHROMA one shade composite; Zen Chroma one shade composite

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 3 teeth with cervical abrasion
• Volunteerily enrolling

You may not qualify if:

• No bruxism
• No carious formation in worn teeth

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (4)

• de Abreu JLB, Sampaio CS, Benalcazar Jalkh EB, Hirata R. Analysis of the color matching of universal resin composites in anterior restorations. J Esthet Restor Dent. 2021 Mar;33(2):269-276. doi: 10.1111/jerd.12659. Epub 2020 Sep 29.

  PMID: 32989879 BACKGROUND

• Durand LB, Ruiz-Lopez J, Perez BG, Ionescu AM, Carrillo-Perez F, Ghinea R, Perez MM. Color, lightness, chroma, hue, and translucency adjustment potential of resin composites using CIEDE2000 color difference formula. J Esthet Restor Dent. 2021 Sep;33(6):836-843. doi: 10.1111/jerd.12689. Epub 2020 Dec 7.

  PMID: 33283966 BACKGROUND

• Iyer RS, Babani VR, Yaman P, Dennison J. Color match using instrumental and visual methods for single, group, and multi-shade composite resins. J Esthet Restor Dent. 2021 Mar;33(2):394-400. doi: 10.1111/jerd.12621. Epub 2020 Aug 25.

  PMID: 32844567 BACKGROUND

• Kobayashi S, Nakajima M, Furusawa K, Tichy A, Hosaka K, Tagami J. Color adjustment potential of single-shade resin composite to various-shade human teeth: Effect of structural color phenomenon. Dent Mater J. 2021 Jul 31;40(4):1033-1040. doi: 10.4012/dmj.2020-364. Epub 2021 Apr 20.

  PMID: 33883353 BACKGROUND

Related Links

• Zen Chroma Universal Composite

MeSH Terms

Conditions

Tooth Discoloration; Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kıvanç Yamanel, PHD

  Baskent University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 9, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

TU (1)