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

November 12, 2021 updated by: Dr. Gerard Kugel, Tufts University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, split-mouth, controlled, examiner-blinded clinical evaluation of Class II restorations using a new bulk-fill composite (SonicFill™ 2) and comparing it to Filtek™ Supreme resin composite placed in the traditional incremental technique.

The primary objective of this study is to evaluate the clinical performance of a sonic-activated, bulk fill composite, SonicFill™ 2, by comparing it to Filtek™ Supreme in the following categories:

Esthetic Properties

  • Surface luster
  • Staining - surface
  • Staining - margin
  • Color match and translucency
  • Esthetic anatomical form

Functional Properties

  • Fracture of material and retention
  • Marginal adaptation
  • Approximate anatomical form - contact point
  • Radio-graphic examination (when applicable)
  • Patient's view

Biological Properties

  • Postoperative (hyper-)sensitivity and tooth vitality
  • Recurrence of caries, erosion, abfraction
  • Tooth integrity (enamel cracks, tooth fractures)
  • Adjacent mucosa

The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFill™ 2, will have comparable results to the traditional incremental technique composite, Filtek™ Supreme, in overall clinical acceptability and in all compared categories

Study Type

Interventional

Enrollment (Actual)

51

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 Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Dental Medicine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is at least 18 years of age
  • Is willing to provide voluntary written informed consent
  • Is in good medical health and able to tolerate the dental procedures
  • Has at least 1 pair of qualifying molars or premolars that require Class II restorations.
  • Restorations must have a buccal to lingual/palatal width equal to or greater than 1/3 the distance from buccal to lingual/palatal cusp tips
  • Study teeth must be in occlusal function and must also be in contact with the neighboring tooth on at least one surface
  • Study teeth must be vital (i.e., free of clinical signs and symptoms of periapical pathology)

Exclusion Criteria:

  • Is currently taking part in an evaluation of other dental restorative materials
  • Has chronic periodontitis or rampant caries
  • Teeth exhibiting clinical signs of periapical pathology
  • Teeth with a history of self-reported preoperative pulpal problems
  • Women who are pregnant (self-reported). It is standard of care to post-pone routine dental procedures and radiographed until after pregnancy.
  • Women who are breast feeding.
  • Known allergy to resin composites or local anesthetics.
  • Abnormal oral soft tissue findings (e.g., open sores, lesions)
  • An employee of the sponsor or members of their immediate family.
  • Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)
  • Any restorative treatment of the teeth involved in the study in the last 12 months.
  • Are unwilling or unable to have dental radiographs or photographs taken of their dentition and soft tissues
  • Any other condition which is the view of the investigator may affect the ability of a patient to complete the study.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SonicFill™ 2
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
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.
Active Comparator: Filtek™ Supreme
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Time Frame: From Baseline up to 2 Years After Restoration Placement

The following properties will be evaluated using the Hickel Grading Criteria:

  1. Surface luster
  2. Staining - surface
  3. Staining - margin
  4. Color match and translucency
  5. Esthetic anatomical form

Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
From Baseline up to 2 Years After Restoration Placement
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Time Frame: From Baseline up to 2 Years After Restoration Placement

The following properties will be evaluated using the Hickel Grading Criteria:

  1. Fracture of material and retention
  2. Marginal adaptation
  3. Approximate anatomical form - contact point
  4. Radio-graphic examination (when applicable)
  5. Patient's view

Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
From Baseline up to 2 Years After Restoration Placement
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Time Frame: From Baseline up to 2 Years After Restoration Placement

The following properties will be evaluated using the Hickel Grading Criteria:

  1. Postoperative (hyper-)sensitivity and tooth vitality
  2. Recurrence of caries, erosion, abfraction
  3. Tooth integrity (enamel cracks, tooth fractures)
  4. Adjacent mucosa

Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
From Baseline up to 2 Years After Restoration Placement

Collaborators and Investigators

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

Sponsor

Tufts University

Collaborators

Kavo Kerr Group

Investigators

  • Principal Investigator: Gerard Kugel, DMD, MS, PhD, TUSDM

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)

June 19, 2017

Primary Completion (Actual)

February 5, 2020

Study Completion (Actual)

February 5, 2020

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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