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Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative

NCT03032705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-12-13

Study results available
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Summary

The purpose of this study is to compare esthetic, functional and biological properties of two restoration materials used to fill cavities. One material is called "Filtek™ Supreme" which is a traditional tooth colored resin composite that is placed in the cavity in layers and hardened with UV light. The second material is called "SonicFill™ 2," which is a bulk fill composite that uses an ultrasonic hand piece to change the material from a solid into a liquid in order to place it into the cavity. This material can be placed in the cavity in 1 layer, and is hardened using UV light. Both materials have been FDA approved as non-significant risk devices for filling cavities.

In each subject, one tooth with a cavity will be randomly selected to receive one filling material, and a second tooth with a cavity will be randomly selected to receive the second material. The fillings will be observed over a two year period to determine clinical acceptability.

Conditions

  • Dental Caries

Interventions

DEVICE

SonicFill™ 2

The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.

DEVICE

Filtek™ Supreme

The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.

Sponsors & Collaborators

  • KaVo Kerr

    collaborator INDUSTRY

  • Tufts University

    lead OTHER

Principal Investigators

  • Gerard Kugel, DMD, MS, PhD · TUSDM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2020-02-05
Completion
2020-02-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032705 on ClinicalTrials.gov