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not sufficient cases for recall to investigate performance of test product
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A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for molars and premolars will be luted with Adhese Universal DC or Adhese Universal.
This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth vitality and failure rate of placed restorations. Tooth vitality is an indicator for the health status of the dental pulp. A vitality test is performed to acquire information about the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test. Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the vitality test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adhese Universal DC | Experimental |
| |
| Adhese Universal | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhese Universal DC | Device | Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth surface |
| Measure | Description | Time Frame |
|---|---|---|
| FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline (7-10 days) |
| FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline |
| FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivoclar Vivadent | Schaan | 9494 | Liechtenstein |
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The recruitment period took place between 14.09.2020-30.06.2021 in the clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adhese Universal DC | Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface |
| FG001 | Adhese Universal | Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adhese Universal DC | Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface |
| BG001 | Adhese Universal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline | Posted | Number | Inlays/Onlays | Baseline (7-10 days) | Inlays/Onlays | Inlays/Onlays |
|
1 year
An adverse event was defined as something unfavourable that happened to the treated tooth and was reported as part of the regular recall by the investigator.
(either technical AE such as fracture of the treated tooth or restoration/tooth replacement and retention loss of the restoration/tooth replacement, or biological AE such as post-operative sensitivity and secondary caries on the treated tooth)
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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 | Adhese Universal DC | Adhese Universal DC: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth surface |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retention Loss | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Team Leader Study Management | Ivoclar Vivadent AG | +4232353780 | patrizia.elkuch-hoch@ivoclar.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 | Mar 10, 2021 | Nov 20, 2023 | Prot_SAP_000.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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| Adhese Universal | Device | Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth |
|
assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" |
| Baseline |
| FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline |
| FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline |
| Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 12 months |
| FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 12 months |
| FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 12 months |
| FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | 12 months |
Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Baseline | Posted | Number | Inlays/Onlays | 12 months | Inlays/Onlays | Inlays/Onlays |
|
|
|
| Secondary | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | restored teeth | Baseline | restored teeth | restored teeth |
|
|
|
| Secondary | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | restored Teeth | Baseline | restored Teeth | restored Teeth |
|
|
|
| Secondary | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Inlays/Onlays | Baseline | Inlays/Onlays | Inlays/Onlays |
|
|
|
| Secondary | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Inlays/Onlays | Baseline | Inlays/Onlays | Inlays/Onlays |
|
|
|
| Secondary | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | restored teeth | 12 months | restored teeth | restored teeth |
|
|
|
| Secondary | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | restored teeth | 12 months | restored teeth | restored teeth |
|
|
|
| Secondary | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Inlays/Onlays | 12 months | Inlays/Onlays | Inlays/Onlays |
|
|
|
| Secondary | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" | Posted | Number | Inlays/Onlays | 12 months | Inlays/Onlays | Inlays/Onlays |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 3 |
| 40 |
| EG001 | Adhese Universal | Adhese Universal: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth | 0 | 40 | 0 | 40 | 4 | 40 |
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| FDI 11 (Postoperative hypersensitivity), FDI Score 3-5 |
|
| Fracture of material and retention, FDI Score 3 |
|
| Fracture of material and retention, FDI Score 4 |
|
| Fracture of material and retention, FDI Score 5 |
|
| Marginal Quality, FDI Score 3-5 |
|
| Fracture of material and retention,FDI Score 5 |
|