Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | June 19, 2017 |
| End Date: | April 2020 |
| Contact: | Gerard Kugel |
| Email: | dentalresearchadministration@tufts.edu |
| Phone: | 617-636-3865 |
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.
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
- Aproximal anatomical form - contact point
- Radiographic 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
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
- Aproximal anatomical form - contact point
- Radiographic 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.
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