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| Name | Class |
|---|---|
| Shofu Inc. | INDUSTRY |
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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.
This is a single-center, non-blinded, controlled, split mouth, clinical trial 18 months in duration.
The purpose of this clinical trial is to evaluate the effectiveness of a new Giomer restorative system (Shofu Beautifil LS) for use in restoring non carious Class V lesions by comparing it to 3M ESPE FiltekTM Supreme in the following categories:
Clinical Assessments (Documentation at baseline, 6months and 18months):
Sensitivity interview- assessed preoperatively (prior to anesthesia, if needed) at baseline and after restoration placement
Dentin Sclerosis Rating- assessed at baseline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHOFU Beautifil II LS | Experimental | Composite: SHOFU Beautifil II LS, Bonding Agent: SHOFU BeautiBond |
|
| 3M/ESPE Filtek Supreme | Active Comparator | Composite: 3M/ESPE Filtek Supreme, Bonding Agent: 3M/ESPE Scotchbond Universal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHOFU Beautifil II LS | Device | Placed under manufacturer's instructions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hickel Criteria | 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 visits. Differences between the two groups for Hickel criteria items will be examined with the Wilcoxon signed-rank test. | Up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Kugel, DMD, MS, PhD | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2025 | Jun 18, 2025 | 8 | ||
| Jul 14, 2025 |
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| 3M/ESPE Filtek Supreme |
| Device |
Placed under manufacturer's instructions |
|
| Jul 31, 2025 |
| 9 |
| Aug 4, 2025 | Aug 21, 2025 | 10 |
| Nov 21, 2025 | Dec 16, 2025 | 11 |
| Jan 14, 2026 | Jan 29, 2026 | 12 |
| Apr 23, 2026 | May 15, 2026 | 13 |