N/A
N=102
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03032705 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category — 25; 25; 2; 2 Teeth
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SonicFill™ 2 (Device); Filtek™ Supreme (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category |
25; 25; 2; 2; 0; 0 | — |
| PRIMARY Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category |
27; 26; 0; 1; 1; 0 | — |
| PRIMARY Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category |
27; 27; 1; 0; 0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03032705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.