CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
SonicFill™ 2 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03032705
NCT03032705N/ACompleted

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

Tufts University·interventional·Posted Jan 26, 2017·Updated Dec 13, 2021

In Brief

A clinical study evaluating SonicFill™ 2 and Filtek™ Supreme for Dental Caries. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
CollaboratorsKaVo Kerr

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 26, 2017
Enrollment StartJun 19, 2017
Primary CompletionFeb 5, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.4 years ago

Interventions

SonicFill™ 2device

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.

Filtek™ Supremedevice

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.