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

NCT03032705 | Completed Results FDA Device

• 1 other identifier: 12311
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Restorations; Composite

Outcome Measures

Primary Outcomes (3)

• 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: 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

  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

  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

Study Arms (2)

SonicFill™ 2

EXPERIMENTAL

Composite: SonicFill™ 2; Bonding Agent: Optibond XRT

Device: SonicFill™ 2

Filtek™ Supreme

ACTIVE COMPARATOR

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

Device: Filtek™ Supreme

Interventions

SonicFill™ 2 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.

SonicFill™ 2

Filtek™ Supreme 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.

Filtek™ Supreme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead
• KaVo Kerr: collaborator

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr Gerard Kugel
• Organization: Tufts University School of Dental Medicine

Gerard.Kugel@tufts.edu

(617) 636-0870

Study Officials

• Gerard Kugel, DMD, MS, PhD

  TUSDM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 26, 2017
• Study Start: June 19, 2017
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: December 13, 2021
• Results First Posted: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)