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Due to slow recruitment.
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This is a split-mouth randomized clinical investigation conducted to evaluate clinical performances of a self-adhesive hybrid resin composite (investigational medical device Surefil) compared to a traditional composite resin, when used for direct restorations of non-carious lesions (NCCLs). The study consists of a 3-year long follow-up period.
The aim of this study is to demonstrate non-inferiority in terms of clinical performance and patient discomfort after direct restorative treatment of class V NCCL with Surefil one restorative material (Dentsply Sirona) in combination with a traditional paste composite "Venus Pearl" employed in combination with iBond universal adhesive (Kulzer Dental) during an observational period of 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restoration with Surefil one hybrid composite | Experimental | In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant. Restoration performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). |
|
| Restoration with Venus Pearl composite | Active Comparator | In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant. After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surefil one | Device | Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Restorative Quality | The restorations will be evaluated using the World Dental Federation (FDI) criteria. | At 36 months follow-up. |
| Assessment of Restorative Quality | The restorations will be evaluated using the United States Public Health Service (USPHS) criteria. | At 36 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Restorative Quality | The restorations will be evaluated using the FDI criteria. | At 6, 12 and 24 months follow-up |
| Assessment of Restorative Quality | The restorations will be evaluated using the USPHS criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Needed to Perform the Restoration | The time needed to perform the restorations will be compared between the groups. | Day 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Breschi, Prof | Clinica Odontoiatrica (DIBINEM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Odontoiatrica (DIBINEM) | Bologna | 40125 | Italy |
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Early termination.
| ID | Title | Description |
|---|---|---|
| FG000 | Restoration With Surefil One Hybrid Composite | In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant. Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). Surefil one: Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL. |
| FG001 | Restoration With Venus Pearl Composite | In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant. After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). Venus Pearl: Restorative material. Traditional paste composite employed in combination with iBond universal adhesive. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restoration With Surefil One Hybrid Composite | In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant. Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). Surefil one: Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Assessment of Restorative Quality | The restorations will be evaluated using the World Dental Federation (FDI) criteria. | Premature termination of study. | Posted | At 36 months follow-up. |
|
16 months.
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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 | Restoration With Surefil One Hybrid Composite | In a split-mouth design, subjects were randomly assigned to restoration with Surefil one hybrid composite in either the left or the right upper quadrant. Restoration will be performed with Surefil one hybrid composite applied according to manufacturer's instruction and cured for 20 seconds with a LED lamp (Smartlamp Pro). Surefil one: Restorative material (Dentsply Sirona). Used for direct restoration of class V NCCL. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AnnaKarin Lungren Dr. | Dentsply Sirona Implants and Consumables | 0046 702 666 492 | annakarin.lundgren@dentsplysirona.com |
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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 | Feb 9, 2024 | Feb 13, 2024 | Prot_SAP_000.pdf |
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Split-mouth design, i.e. each subject have both treatment arms.
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The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI.
| Venus Pearl | Device | Restorative material. Traditional paste composite employed in combination with iBond universal adhesive. |
|
| At 6, 12 and 24 months follow-up |
| Assessment of Aesthetics | The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI. | At 6, 12, 24 and 36 months follow-up |
| Level of Pain | Sensitivity index: thermal yes/no, if yes then Visual Analogue Scale (VAS) index for level of pain. Air yes/no, if yes then VAS index for level of pain. | At 6, 12, 24 and 36 months follow-up |
| BG001 | Restoration With Venus Pearl Composite | In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant. After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). Venus Pearl: Restorative material. Traditional paste composite employed in combination with iBond universal adhesive. |
| BG002 | Total | Total of all reporting groups |
| Restoration type |
|
| Participants |
| No |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | No | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
|
| Primary | Assessment of Restorative Quality | The restorations will be evaluated using the United States Public Health Service (USPHS) criteria. | Premature termination of study. | Posted | At 36 months follow-up |
|
|
| Secondary | Assessment of Restorative Quality | The restorations will be evaluated using the FDI criteria. | Not Posted | At 6, 12 and 24 months follow-up | Participants |
| Secondary | Assessment of Restorative Quality | The restorations will be evaluated using the USPHS criteria. | Not Posted | At 6, 12 and 24 months follow-up | Participants |
| Secondary | Assessment of Aesthetics | The aesthetic integration of the restoration will be evaluated by two experienced and blinded operators following the aesthetic criteria of the FDI. | Not Posted | At 6, 12, 24 and 36 months follow-up | Participants |
| Secondary | Level of Pain | Sensitivity index: thermal yes/no, if yes then Visual Analogue Scale (VAS) index for level of pain. Air yes/no, if yes then VAS index for level of pain. | Not Posted | At 6, 12, 24 and 36 months follow-up | Participants |
| Other Pre-specified | Time Needed to Perform the Restoration | The time needed to perform the restorations will be compared between the groups. | Not Posted | Day 0 | Participants |
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Restoration With Venus Pearl Composite | In a split-mouth design, subjects were randomly assigned to restoration with Venus Pearl composite in either the left or the right upper quadrant. After the application of the adhesive system (iBond universal), the Venus Pearl composite will be layered on the cavity and cured for 20 seconds with a LED lamp Smartlamp Pro). Venus Pearl: Restorative material. Traditional paste composite employed in combination with iBond universal adhesive. | 0 | 16 | 0 | 16 | 0 | 16 |
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