MedDataX Logo

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

NCT ID: NCT03032705

Last Updated: 2021-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2020-02-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Restorations Composite

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SonicFill™ 2

Composite: SonicFill™ 2; Bonding Agent: Optibond XRT

Group Type EXPERIMENTAL

SonicFill™ 2

Intervention Type DEVICE

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™ Supreme

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

Group Type ACTIVE_COMPARATOR

Filtek™ Supreme

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KaVo Kerr

INDUSTRY

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Gerard Kugel

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gerard Kugel, DMD, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

TUSDM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12311

Identifier Type: -

Identifier Source: org_study_id