Caries, Defective Restorations
Conditions
Brief summary
This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).
Detailed description
The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.
Interventions
DEVICEAlcasite restorative material
Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing
DEVICEBulk fill glass hybrid restorative material
Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing
Sponsors
KU Leuven
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Split-Mouth Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject's age between 18 and 65 years old * Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars * Vital teeth * 2 restorations per patient: both cavities should have comparable size and dimensions * Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included) * Low to moderate caries rate/normal periodontal status with good home care
Exclusion criteria
* Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results) * Pulp exposure or signs of pulpal infection * No signs of pulpitis or hypersensitivity (Visual analog scale \< 3 on biting and temperature sensitivity) * History of allergy to glass ionomer, acrylate/methacrylate monomers * Pregnancy * Chronic disease with oral manifestations or primary oral pathology * Bad oral hygiene * High caries rate or periodontal problems * Absence of antagonists * Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 5 years | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 6 months to 3 years | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3) |
| Survival Rate | 6 months to 5 years | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Survival: Score equal to/above 4) |
| Quality criteria (Clinical performance) | 6 months to 5 years | assessed following FDI criteria on a scale from 1 very good to 5 unacceptable: e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations |
Countries
Belgium
Outcome results
None listed