clinical evaluation of kerr sonicfill™ 2 vs 3m espe filtek™ supreme ultra universal restorative

Conditions: Dental Caries

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.

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

Eligibility criteria:
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.

Keywords: restorations composite