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

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

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.

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

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.