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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Filtek™ Supreme; Device: SonicFill™ 2

• Registration Number: NCT03032705
• Lead Sponsor: Tufts University

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

Study Timeline

• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Study Start: 2017-06-19
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Results First Submitted: 2021-05-20
• Results First Submitted QC: 2021-10-14
• Status Verified: 2021-11
• Results First Posted: 2021-11-12
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filtek™ Supreme	Filtek™ Supreme	Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
SonicFill™ 2	SonicFill™ 2	Composite: SonicFill™ 2; Bonding Agent: Optibond XRT

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States