Defective Tooth Restorations, Dental Caries
Conditions
Keywords
caries, restoration
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAdhese 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
DEVICEAdhese 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
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-65 years * Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries * The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth. * Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information) * 2-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity * Max. 2 restorations per participant in different quadrants. * Vital tooth * Healthy periodontium, no active periodontitis * Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point. * Sufficient language skills
Exclusion criteria
* Sufficient isolation not possible, dry working field cannot be guaranteed * Participants with a proven allergy to one of the ingredients of the materials used * Participants with proven allergy to local anaesthetics * High caries activity/ poor oral hygiene * Participants with severe systemic diseases * Pregnancy * Nonvital tooth or tooth with irreversible pulpitis * Indication for direct pulp capping * Symptoms of SARS-CoV2 infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | Baseline (7-10 days) | 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 |
| FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Baseline | 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 |
| FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Baseline | 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 |
| FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Baseline | 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 |
| FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Baseline | 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 |
Countries
Liechtenstein
Participant flow
Recruitment details
The recruitment period took place between 14.09.2020-30.06.2021 in the clinic.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Adhese Universal DC | Adhese Universal | Total |
|---|---|---|---|
| Age, Customized 18-65 years | 40 Participants | 40 Participants | 80 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 27 Participants | 25 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 3 / 40 | 4 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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
Time frame: Baseline (7-10 days)
Population: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 1 | 39 Inlays/Onlays |
| Adhese Universal DC | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 2 | 0 Inlays/Onlays |
| Adhese Universal DC | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 3-5 | 0 Inlays/Onlays |
| Adhese Universal | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 1 | 38 Inlays/Onlays |
| Adhese Universal | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 2 | 1 Inlays/Onlays |
| Adhese Universal | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 3-5 | 0 Inlays/Onlays |
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
Time frame: 12 months
Population: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 1 | 37 Inlays/Onlays |
| Adhese Universal DC | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 2 | 0 Inlays/Onlays |
| Adhese Universal DC | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 3-5 | 0 Inlays/Onlays |
| Adhese Universal | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 1 | 36 Inlays/Onlays |
| Adhese Universal | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 2 | 0 Inlays/Onlays |
| Adhese Universal | FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 11 (Postoperative hypersensitivity), FDI Score 3-5 | 0 Inlays/Onlays |
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
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 1 | 40 restored teeth |
| Adhese Universal DC | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 2-5 | 0 restored teeth |
| Adhese Universal | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 1 | 40 restored teeth |
| Adhese Universal | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 2-5 | 0 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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 1 | 40 restored Teeth |
| Adhese Universal DC | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 2-5 | 0 restored Teeth |
| Adhese Universal | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 1 | 40 restored Teeth |
| Adhese Universal | FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | FDI 13 (Tooth Integrity), FDI Score 2-5 | 0 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
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention,FDI Score 1 | 37 Inlays/Onlays |
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention,FDI Score 2-4 | 0 Inlays/Onlays |
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention,FDI Score 5 | 3 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention,FDI Score 1 | 36 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention,FDI Score 2-4 | 0 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention,FDI Score 5 | 4 Inlays/Onlays |
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 2 | 0 Inlays/Onlays |
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 4 | 0 Inlays/Onlays |
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 3 | 0 Inlays/Onlays |
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 5 | 1 Inlays/Onlays |
| Adhese Universal DC | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 1 | 39 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 5 | 1 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 1 | 38 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 2 | 0 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 3 | 1 Inlays/Onlays |
| Adhese Universal | FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5 | Fracture of material and retention, FDI Score 4 | 0 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
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 1 | 37 Inlays/Onlays |
| Adhese Universal DC | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 2-5 | 0 Inlays/Onlays |
| Adhese Universal | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 1 | 36 Inlays/Onlays |
| Adhese Universal | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 2-5 | 0 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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 1 | 37 Inlays/Onlays |
| Adhese Universal DC | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 2 | 2 Inlays/Onlays |
| Adhese Universal DC | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 3-5 | 0 Inlays/Onlays |
| Adhese Universal | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 1 | 37 Inlays/Onlays |
| Adhese Universal | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 2 | 2 Inlays/Onlays |
| Adhese Universal | FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5 | Marginal Quality, FDI Score 3-5 | 0 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
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 1 | 40 restored teeth |
| Adhese Universal DC | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 2-5 | 0 restored teeth |
| Adhese Universal | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 1 | 40 restored teeth |
| Adhese Universal | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 2-5 | 0 restored teeth |
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adhese Universal DC | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 1 | 40 restored teeth |
| Adhese Universal DC | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 2-5 | 0 restored teeth |
| Adhese Universal | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 1 | 40 restored teeth |
| Adhese Universal | Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5 | Vitality, FDI Score 2-5 | 0 restored teeth |