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

November 15, 2023 updated by: Leyla Kerimova, Baskent University

Evaluation of 2-year Clinical Performance of Two Different Single Color Universal Composite Resin Restorative Materials: A Double-blind Prospective Randomized Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ruhsan Müdüroğlu Adıgüzel, DDS
  • Phone Number: +905067042949
  • Email: ruhsanm@gmail.com

Study Locations

  • Turkey
      • Ankara, Turkey, 06490
        • Recruiting
        • Başkent University
        • Contact:
        • Contact:
          • Ruhsan Müdüroğlu Adıgüzel, DDS
          • Phone Number: +905067042949
          • Email: ruhsanm@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • At least 3 teeth with cervical abrasion
  • Volunteerily enrolling

Exclusion Criteria:

  • No bruxism
  • No carious formation in worn teeth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OMNICHROMA one shade composite
a one-shade composite resin as experimental group
Procedure: Restoration with-tooth colored material
Restoration of abrasions with different composite resin materials
Active Comparator: Zen Chroma one shade composite
a one-shade composite resin as experimental group
Procedure: Restoration with-tooth colored material
Restoration of abrasions with different composite resin materials
Active Comparator: Filtek Z250 multi shade composite
a multi-shade composite resin as control group
Procedure: Restoration with-tooth colored material
Restoration of abrasions with different composite resin materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance according to the modified United States Public Health Service criteria
Time Frame: 6,12,18, 24 and 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of restorations according to the World Dental Organization criteria
Time Frame: 6,12,18, 24 and 36 months
Retention, marginal discoloration, marginal adaptation, secondary caries and postoperative sensitivity will be scored as 1) clinically excellent, 2) clinicallay good, 3) clinically sufficient, 4) clinically unsatisfactory and 5) clinically poor
6,12,18, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Study Director: Kıvanç Yamanel, PHD, Başkent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 4, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-KA22/25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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