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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Dental Caries

Intervention / Treatment
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* Device: SonicFill™ 2
* Device: Filtek™ Supreme


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SonicFill™ 2<br>Composite: SonicFill™ 2; Bonding Agent: Optibond XRT | Device: SonicFill™ 2<br>* 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.<br>|
| Active Comparator: Filtek™ Supreme<br>Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive | Device: Filtek™ Supreme<br>* 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.<br>|

What is the study measuring?
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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 | 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 | 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: 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 | 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: 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 | From Baseline up to 2 Years After Restoration Placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restorations, Composite