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NCT03032705 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
A NA study, sponsored by Tufts University.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT03032705: Completed NA study, sponsored by Tufts University.
NCT03032705 is a NA study that has completed, run by Tufts University. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03032705, a NA study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study 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.
Primary Outcome
The following properties will be evaluated using the Hickel Grading Criteria: 1. Surface luster 2. Staining - surface 3. Staining - margin 4. Color match and translucency 5. Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Interventions
- DEVICE SonicFill™ 2
- DEVICE Filtek™ Supreme
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-06-19 |
| Est. Completion | 2020-02-05 |
| Phase | NA |
What the finished NCT03032705 record still lists
NCT03032705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which SonicFill™ 2 is the first listed.
NCT03032705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03032705 about?
NCT03032705 is a clinical study titled "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. ...
What is the current status of trial NCT03032705?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2017-06-19. Estimated completion is 2020-02-05.
What interventions are being tested in trial NCT03032705?
The interventions under investigation include: SonicFill™ 2 (DEVICE), Filtek™ Supreme (DEVICE).
Who is sponsoring clinical trial NCT03032705?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03032705's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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