Caries, Dental, Class I Dental Restorations, Class II Dental Restorations, Insufficient Dental Restoration
Conditions
Brief summary
The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.
Interventions
DEVICEPlacement of indirect dental restoration
The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-65 years * Informed consent signed and understood by the subject * Indication for indirect restorations (inlay, onlay) in molar or premolar * The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth. * visual analogue scale (VAS)<4 (0=no pain, 10=maximum conceivable pain) * 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
* Insufficient isolation * 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 * Tooth with irreversible pulpitis * Indication for direct pulp capping * Bleaching of teeth within the last 14 days * Usage of peroxide-based disinfectants within the last 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hypersensitivity | 1 month | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fracture Rate | 5 years | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) |
| Marginal Quality | 5 years | will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome) |
Countries
Liechtenstein
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| New dual-cure adhesive The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations. | 45 |
| New dual-cure adhesive The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Placement of indirect dental restoration: The newly developed dual-cure adhesive will be used for the placement of indirect restorations. | 47 |
| Total | 92 |
Baseline characteristics
| Characteristic | New dual-cure adhesive |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 3 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Postoperative Hypersensitivity
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Time frame: 1 month
Population: One patient was not able to visit 1-month recall (no-show)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| New dual-cure adhesive | Postoperative Hypersensitivity | FDI Score 1 | 46 Restorations |
| New dual-cure adhesive | Postoperative Hypersensitivity | FDI Score 2-5 | 0 Restorations |
Secondary
Fracture Rate
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Time frame: 5 years
Secondary
Marginal Quality
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Time frame: 5 years