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NCT03153969 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of a New Giomer Restorative System in Class V Restorations
A NA study, sponsored by Tufts University.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
NCT03153969: Completed NA study, sponsored by Tufts University.
NCT03153969 is a NA study that has completed, run by Tufts University. The registered enrollment target is 49 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03153969, a NA study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions. 3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this study (Group 1). This is a light-activated, flowable restorative composite. Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is the second composite that will be used in this study (Group 2) Giomer is a collective term for dental materials that will release ions, such as fluoride. Results from previous studies show that the released ions may have beneficial effects on the tooth, including strengthening the tooth. In each participant, one tooth with a class V lesion will be randomized to group 1, and a second tooth with a class V lesion will be randomized to group 2. The restorations will be observed over 18 months to determine clinical acceptability.
Primary Outcome
Clinical assessments (Esthetic properties: surface luster, surface staining, marginal staining, color match, anatomical form, Functional properties: marginal adaptation, fracture of material and retention, radiographic examination, patient's view, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa) will be performed by two trained examiners other than the operating clinician using modified Hickel criteria at baseline and follow-up
Interventions
- DEVICE SHOFU Beautifil II LS
- DEVICE 3M/ESPE Filtek Supreme
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2022-11-15 |
| Phase | NA |
What the finished NCT03153969 record still lists
NCT03153969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which SHOFU Beautifil II LS is the first listed.
NCT03153969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03153969 about?
NCT03153969 is a clinical study titled "Clinical Evaluation of a New Giomer Restorative System in Class V Restorations". The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions. 3M ESPE FiltekTM Supreme is one of the composite resin materials that will ...
What is the current status of trial NCT03153969?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2017-08-28. Estimated completion is 2022-11-15.
What interventions are being tested in trial NCT03153969?
The interventions under investigation include: SHOFU Beautifil II LS (DEVICE), 3M/ESPE Filtek Supreme (DEVICE).
Who is sponsoring clinical trial NCT03153969?
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 NCT03153969's enrollment target sits among peer trials
49 1379th of 2000 higher than 620 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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