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| Name | Class |
|---|---|
| KaVo Kerr | INDUSTRY |
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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 "Filtekâ„¢ 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 "SonicFillâ„¢ 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 (SonicFillâ„¢ 2) and comparing it to Filtekâ„¢ 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, SonicFillâ„¢ 2, by comparing it to Filtekâ„¢ Supreme in the following categories:
Esthetic Properties
Functional Properties
Biological Properties
The hypothesis to be tested is that the sonic-activated, bulk fill composite, SonicFillâ„¢ 2, will have comparable results to the traditional incremental technique composite, Filtekâ„¢ Supreme, in overall clinical acceptability and in all compared categories
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SonicFillâ„¢ 2 | Experimental | Composite: SonicFillâ„¢ 2; Bonding Agent: Optibond XRT |
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| Filtekâ„¢ Supreme | Active Comparator | Composite: Filtekâ„¢ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbondâ„¢ Universal Adhesive |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SonicFillâ„¢ 2 | Device | The intervention in arm 1 is SonicFillâ„¢ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | The following properties will be evaluated using the Hickel Grading Criteria:
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable | From Baseline up to 2 Years After Restoration Placement |
| Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | The following properties will be evaluated using the Hickel Grading Criteria:
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable | From Baseline up to 2 Years After Restoration Placement |
| Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | The following properties will be evaluated using the Hickel Grading Criteria:
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable | From Baseline up to 2 Years After Restoration Placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Kugel, DMD, MS, PhD | TUSDM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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Unit = Teeth. 51 participants were randomized in this study, and a total of 102 teeth were studied. Therefore 51 participants and 102 units.
| ID | Title | Description |
|---|---|---|
| FG000 | SonicFillâ„¢ 2 | Composite: SonicFillâ„¢ 2; Bonding Agent: Optibond XRT SonicFillâ„¢ 2: The intervention in arm 1 is SonicFillâ„¢ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer. |
| FG001 | Filtekâ„¢ Supreme | Composite: Filtekâ„¢ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbondâ„¢ Universal Adhesive Filtekâ„¢ Supreme: The intervention in arm 2 is Filtekâ„¢ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Each participants contributed 2 randomly selected teeth for each study group therefore 1 participant contributing 2 study teeth in each case. Therefore total number of participants is 45 and total number of units is 90.
| ID | Title | Description |
|---|---|---|
| BG000 | SonicFillâ„¢ 2 | Composite: SonicFillâ„¢ 2; Bonding Agent: Optibond XRT SonicFillâ„¢ 2: The intervention in arm 1 is SonicFillâ„¢ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer. |
| BG001 | Filtekâ„¢ Supreme |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category | The following properties will be evaluated using the Hickel Grading Criteria:
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable | 45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFillâ„¢ 2 (1 restoration replaced) and 27 teeth with Filtekâ„¢ Supreme (2 restorations replaced). | Posted | Count of Units | Teeth | No | From Baseline up to 2 Years After Restoration Placement | Teeth | Teeth |
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Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SonicFillâ„¢ 2 | Composite: SonicFillâ„¢ 2; Bonding Agent: Optibond XRT SonicFillâ„¢ 2: The intervention in arm 1 is SonicFillâ„¢ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture of restorations | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Gerard Kugel | Tufts University School of Dental Medicine | (617) 636-0870 | Gerard.Kugel@tufts.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2018 | May 5, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2017 | May 5, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Filtekâ„¢ Supreme | Device | The intervention in arm 2 is Filtekâ„¢ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class. |
|
Composite: Filtekâ„¢ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbondâ„¢ Universal Adhesive Filtekâ„¢ Supreme: The intervention in arm 2 is Filtekâ„¢ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class. |
| BG002 | Total | Total of all reporting groups |
| teeth |
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| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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Composite: SonicFillâ„¢ 2; Bonding Agent: Optibond XRT
SonicFillâ„¢ 2: The intervention in arm 1 is SonicFillâ„¢ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
| OG001 | Filtekâ„¢ Supreme | Composite: Filtekâ„¢ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbondâ„¢ Universal Adhesive Filtekâ„¢ Supreme: The intervention in arm 2 is Filtekâ„¢ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class. |
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| Primary | Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category | The following properties will be evaluated using the Hickel Grading Criteria:
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable | 45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFillâ„¢ 2 (1 restoration replaced) and 27 teeth with Filtekâ„¢ Supreme (2 restorations replaced). | Posted | Count of Units | Teeth | No | From Baseline up to 2 Years After Restoration Placement | Teeth | Teeth |
|
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| Primary | Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category | The following properties will be evaluated using the Hickel Grading Criteria:
Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable | 45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFillâ„¢ 2 (1 restoration replaced) and 27 teeth with Filtekâ„¢ Supreme (2 restorations replaced). | Posted | Count of Units | Teeth | No | From Baseline up to 2 Years After Restoration Placement | Teeth | Teeth |
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| 0 |
| 51 |
| 0 |
| 51 |
| 14 |
| 45 |
| EG001 | Filtekâ„¢ Supreme | Composite: Filtekâ„¢ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbondâ„¢ Universal Adhesive Filtekâ„¢ Supreme: The intervention in arm 2 is Filtekâ„¢ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class. | 0 | 51 | 0 | 51 | 15 | 45 |
| Soft tissue irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Post operative sensitivity/Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pulp exposure risk, healing of non- study site, Alterantion of study site due to non-study site tx | General disorders | Non-systematic Assessment |
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| Fracture of Material and Retention at end of study : Number of teeth rated 2 |
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| Fracture of Material and Retention at end of study : Number of teeth rated 3 |
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| Fracture of Material and Retention at end of study : Number of teeth rated 4 |
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| Fracture of Material and Retention at end of study : Number of teeth rated 5 |
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| Marginal Adaptation at end of study : Number of teeth rated 1 |
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| Marginal Adaptation at end of study : Number of teeth rated 2 |
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| Marginal Adaptation at end of study : Number of teeth rated 3 |
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| Marginal Adaptation at end of study : Number of teeth rated 4 |
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| Marginal Adaptation at end of study : Number of teeth rated 5 |
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| Radiographic Examination at end of study : Number of teeth rated 1 |
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| Radiographic Examination at end of study : Number of teeth rated 2 |
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| Radiographic Examination at end of study : Number of teeth rated 3 |
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| Radiographic Examination at end of study : Number of teeth rated 4 |
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| Radiographic Examination at end of study : Number of teeth rated 5 |
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| Patient's View at end of study : Number of teeth rated 1 |
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| Patient's View at end of study : Number of teeth rated 2 |
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| Patient's View at end of study : Number of teeth rated 3 |
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| Patient's View at end of study : Number of teeth rated 4 |
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| Patient's View at end of study : Number of teeth rated 5 |
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| Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 2 |
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| Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 3 |
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| Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 4 |
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| Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 5 |
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| Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 1 |
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| Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 2 |
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| Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 3 |
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| Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 4 |
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| Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 5 |
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| Tooth Integrity at end of study : Number of teeth rated 1 |
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| Tooth Integrity at end of study : Number of teeth rated 2 |
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| Tooth Integrity at end of study : Number of teeth rated 3 |
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| Tooth Integrity at end of study : Number of teeth rated 4 |
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| Tooth Integrity at end of study : Number of teeth rated 5 |
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| Adjacent Mucosa at end of study : Number of teeth rated 1 |
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| Adjacent Mucosa at end of study : Number of teeth rated 2 |
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| Adjacent Mucosa at end of study : Number of teeth rated 3 |
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| Adjacent Mucosa at end of study : Number of teeth rated 4 |
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| Adjacent Mucosa at end of study : Number of teeth rated 5 |
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