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

NCT ID: NCT06125132

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-11-01

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.

Detailed Description

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.

OMNICHROMA (Tokuyama Dental) is the first universal composite resin restorative material that is claimed to aesthetically match every tooth color from A1 to D4 in a single shade. The manufacturer declares that OMNICHROMA, with its equally sized supra-nano spherical filler (260 nm spherical silicon dioxide-Zzirconium dioxide), adapts to each of the 16 VITA classic colors thanks to Smart Chromatic Technology.

Zenchroma (President Dental) is a hybrid composite material containing an ultra-thin, radiopaque glass filler. The manufacturer declares that the filling color perfectly adapts to the tooth structure with its chameleon effect.

As we know, there is no study investigating the clinical performance of these two universal composites. 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 USPHS and FDI criteria.

In this study, two different null hypotheses were established. The first null hypothesis of this study is; It is concluded that there is no difference between 2 different single color universal composite resin materials (OMNICHROMA and Zenchroma) in terms of clinical performance in restorations of non-carious cervical lesions. The second null hypothesis of the study is that universal composite resin materials are not different from the control group, multicolored composite resin (Filtek Z250, 3M), in terms of clinical performance in restorations of non-carious cervical lesions.

Conditions

Tooth Discoloration; Tooth Wear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OMNICHROMA one shade composite

a one-shade composite resin as experimental group

Group Type: ACTIVE_COMPARATOR

Restoration with-tooth colored material

Intervention Type: PROCEDURE

Restoration of abrasions with different composite resin materials

Zen Chroma one shade composite

a one-shade composite resin as experimental group

Group Type: ACTIVE_COMPARATOR

Restoration with-tooth colored material

Intervention Type: PROCEDURE

Restoration of abrasions with different composite resin materials

Filtek Z250 multi shade composite

a multi-shade composite resin as control group

Group Type: ACTIVE_COMPARATOR

Restoration with-tooth colored material

Intervention Type: PROCEDURE

Restoration of abrasions with different composite resin materials

Interventions

Restoration with-tooth colored material

Restoration of abrasions with different composite resin materials

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• At least 3 teeth with cervical abrasion
• Volunteerily enrolling

Exclusion Criteria

• No bruxism
• No carious formation in worn teeth

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Leyla Kerimova

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kıvanç Yamanel, PHD

Role: STUDY_DIRECTOR

Baskent University

Locations

Baskent University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32989879 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33283966 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32844567 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33883353 (View on PubMed)

Related Links

http://www.presidentdental.com

Zen Chroma Universal Composite

Other Identifiers

D-KA22/25

Identifier Type: -

Identifier Source: org_study_id