Caries, Dental Trauma
Conditions
Brief summary
A clinical trial with an experimental glass ceramic (shades A1, A2 and A3) to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted.
Interventions
DEVICEindirect restorative treatment with a glass ceramic
Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.
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 * 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) * Pre-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. * 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 * Symptoms of SARS (severe acute respiratory syndrome)-CoV2 (Corona Virus 2) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate of Inlays and Onlays | Baseline (7-10 days after insertion of restoration) | Inlay and onlay restorations were examined by a dentist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality Criteria (Modified FDI Criteria) | Baseline (7-10 days after insertion of restoration) | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable (e.g. surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations) |
Countries
Liechtenstein
Participant flow
Recruitment details
The recruitment period lasted from 14.09.2021-15.11.2021 in the dental clinic.
Participants by arm
| Arm | Count |
|---|---|
| Inlay/Onlay indirect restorative treatment with a glass ceramic: Inlays and onlays of glass ceramic for molars and premolars are adhesively luted. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Inlay/Onlay | — |
|---|---|---|
| Age, Customized 18-65 years old | 13 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Survival Rate of Inlays and Onlays
Inlay and onlay restorations were examined by a dentist
Time frame: Baseline (7-10 days after insertion of restoration)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inlay/Onlay | Survival Rate of Inlays and Onlays | 13 Inlays/Onlays |
Secondary
Quality Criteria (Modified FDI Criteria)
assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable (e.g. surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations)
Time frame: Baseline (7-10 days after insertion of restoration)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 1 (Surface Luster), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 1 (Surface Luster), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 2a (Surface Staining), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 2a (Surface Staining), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 2b (Margin Staining), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 2b (Margin Staining), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 3 (Color Match), FDI Score 1 | 10 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 3 (Color Match), FDI Score 2 | 3 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 3 (Color Match), FDI Score 3-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 3 (Translucency), FDI Score 1 | 12 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 3 (Translucency), FDI Score 2 | 1 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 3 (Translucency), FDI Score 3-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 5 (Fractures of material and retention), FDI Score 1 | 8 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 5 (Fractures of material and retention), FDI Score 2 | 5 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 5 (Fractures of material and retention), FDI Score 3-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 6 (Marginal adaptation), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 6 (Marginal adaptation), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 7a (Occlusal contour and wear, qualitatively), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 7a (Occlusal contour and wear, qualitatively), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 10 (Patient's view), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 10 (Patient's view), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 11 (Postoperative (hyper-)sensitivity and tooth vitality), FDI Score 1 | 12 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 11 (Postoperative (hyper-)sensitivity and tooth vitality), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 12 (Recurrence of caries (CAR), erosion, abfraction), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 12 (Recurrence of caries (CAR), erosion, abfraction), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 13 (Tooth integrity (enamel cracks, tooth fractures), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 13 (Tooth integrity (enamel cracks, tooth fractures), FDI Score 2-5 | 0 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 15 (Adjacent mucosa), FDI Score 1 | 13 inlays/onlays |
| Inlay/Onlay | Quality Criteria (Modified FDI Criteria) | FDI 15 (Adjacent mucosa), FDI Score 2-5 | 0 inlays/onlays |