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

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SonicFill™ 2

Filtek™ Supreme

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Restorations, Composite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Tufts University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SonicFill™ 2

Filtek™ Supreme

Arm Description

Composite: SonicFill™ 2; Bonding Agent: Optibond XRT

Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive

Outcomes

Primary Outcome Measures

Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category

The following properties will be evaluated using the Hickel Grading Criteria: Surface luster Staining - surface Staining - margin Color match and translucency Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category

The following properties will be evaluated using the Hickel Grading Criteria: Fracture of material and retention Marginal adaptation Approximate anatomical form - contact point Radio-graphic examination (when applicable) Patient's view Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category

The following properties will be evaluated using the Hickel Grading Criteria: Postoperative (hyper-)sensitivity and tooth vitality Recurrence of caries, erosion, abfraction Tooth integrity (enamel cracks, tooth fractures) Adjacent mucosa Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable

Secondary Outcome Measures

Full Information

NCT ID

NCT03032705

First Posted

January 19, 2017

Last Updated

November 12, 2021

Sponsor

Tufts University

Collaborators

Kavo Kerr Group

1. Study Identification

Unique Protocol Identification Number

NCT03032705

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 19, 2017 (Actual)

Primary Completion Date

February 5, 2020 (Actual)

Study Completion Date

February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

Collaborators

Kavo Kerr Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

Restorations, Composite

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SonicFill™ 2

Arm Type

Experimental

Arm Description

Composite: SonicFill™ 2; Bonding Agent: Optibond XRT

Arm Title

Filtek™ Supreme

Arm Type

Active Comparator

Arm Description

Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive

Intervention Type

Device

Intervention Name(s)

SonicFill™ 2

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Filtek™ Supreme

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category

Description

Time Frame

From Baseline up to 2 Years After Restoration Placement

Title

Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category

Description

Time Frame

From Baseline up to 2 Years After Restoration Placement

Title

Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category

Description

Time Frame

From Baseline up to 2 Years After Restoration Placement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerard Kugel, DMD, MS, PhD

Organizational Affiliation

TUSDM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts University School of Dental Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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