MedTrace Logo

Clinical Evaluation of a New Giomer Restorative System in Class V Restorations

NCT03153969 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-11-16

No results posted yet for this study

Summary

The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions.

3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this study (Group 1). This is a light-activated, flowable restorative composite.

Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is the second composite that will be used in this study (Group 2) Giomer is a collective term for dental materials that will release ions, such as fluoride. Results from previous studies show that the released ions may have beneficial effects on the tooth, including strengthening the tooth.

In each participant, one tooth with a class V lesion will be randomized to group 1, and a second tooth with a class V lesion will be randomized to group 2. The restorations will be observed over 18 months to determine clinical acceptability.

Conditions

  • Non-carious Cervical Lesions

Interventions

DEVICE

SHOFU Beautifil II LS

Placed under manufacturer's instructions

DEVICE

3M/ESPE Filtek Supreme

Placed under manufacturer's instructions

Sponsors & Collaborators

  • Shofu Inc.

    collaborator INDUSTRY

  • Tufts University

    lead OTHER

Principal Investigators

  • Gerard Kugel, DMD, MS, PhD · Tufts University School of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2022-09-30
Completion
2022-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03153969 on ClinicalTrials.gov