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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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
Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth
Ivoclar Vivadent
Schaan, Liechtenstein
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"
Time frame: 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"
Time frame: 12 months
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"
Time frame: Baseline
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"
Time frame: 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"
Time frame: 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"
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Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 12 months