Introduction
Materials and methods
Materials
Manufacturer | Lot no | Shade | Type | Composition | Filler load wt%/vol% | |
---|---|---|---|---|---|---|
Fill-Up | Coltene Waledent AG, Altstatten, Switzerland | J38436 | Universal | Medium-viscosity micro-hybrid dual-cure bulk-fill | TMPTMA, UDMA, TEGDMA, Bis-GMA, dibenzoyl peroxide, benzoyl peroxide, zinc oxide coated | 65/49 |
QuiXfil | Dentsply, Konstanz, Germany | 0504 | Universal | High-viscosity sculptable micro-hybrid light-cure bulk-fill | UDMA, TEGDMA, di and tri-methacrylate, strontium-alumino-sodium-fluoro-phosphate-silicate glass | 86/66 |
Tetric N-Ceram Bulk Fill | Ivoclar Vivadent, AG, Schaan, Liechtenstein | Y48204 | IVA | High-viscosity sculptable nano-hybrid light-cure bulk-fill | Bis-GMA, Bis-EMA, UDMA, barium glass, ytterbium trifluoride, mixed oxide, and copolymers | 80/60 |
N-Etch Etching Gel | Ivoclar Vivadent, AG, Schaan, Liechtenstein | X27261 | N/A | Etching gel | 37% phosphoric acid | N/A |
ONE COAT 7 UNIVERSAL | Coltene Waledent AG, Altstatten, Switzerland | J32343 | N/A | Universal adhesive | HEMA, hydroxypropyl-methacrylate, MMA-modified polyacrylic acid, UDMA, amorphous silicic, 10-MDP | N/A |
One Coat 7.0 Activator | Coltene Waledent AG, Altstatten, Switzerland | J67279 | N/A | Activator (for chemical- and dual-cure materials) | Ethanol, water, activator | N/A |
Ethical considerations
Sample size calculation
Inclusion and exclusion criteria
Study design
Clinical procedures
Cavity preparation
Restorative procedures
Evaluation procedures
A. Esthetic properties | 1. Surface luster | 2. Staining a. surface b. margin | 3. Color match and translucency | 4. Esthetic anatomical form | B. Functional properties | 5. Fracture of material and retention | 6. Marginal adaptation | 7. Occlusal wear | 8. Proximal contact | 9. Radiographic examination | C. Biological properties | 10. Postoperative (hyper-)sensitivity and tooth vitality | 11. Recurrence of caries | 12. Tooth integrity (enamel cracks, tooth fractures) |
1. Clinically excellent/very good | 1.1 Luster comparable to enamel | 2a.1 No surface staining 2b.1 No marginal staining | 3.1 Good color match, no difference in shade and/or translucency | 4.1 Form is ideal | 1. Clinically excellent/very good | 5.1 No fractures/cracks | 6.1 Harmonious outline, no gaps, no white or discolored lines | 7.1 Wear corresponding to 80–120% of enamel | 8.1 Normal contact point (floss can pass) | 9.1 No pathology, harmonious transition between restoration and tooth | 1. Clinically very good | 10.1 No hypersensitivity, normal vitality | 11.1 No secondary or primary caries | 12.1 Complete integrity |
2. Clinically good (after polishing probably very good) | 1.2.1 Slightly dull, not noticeable from speaking distance 1.2.2 Some isolated pores | 2a.2 Minor surface staining, easily removable by polishing 2b.2 Minor marginal staining, easily removable by polishing | 3.2 Minor deviations in shade and/or translucency | 4.2 Form is only slightly deviated from the normal | 2. Clinically good | 5.2 Small hairline crack | 6.2.1 Marginal gap (< 150 μm), white lines 6.2.2 Small marginal fracture removable by polishing 6.2.3 Slight ditching, slight step/flashes, minor irregularities | 7.2 50–80% or 120–150% wear compared to that of corresponding enamel | 8.2. Contact slightly too strong but no disadvantage (floss can only pass with pressure) | 9.2.1 Acceptable cement excess present 9.2.2 Positive/negative step present at margin < 150 μm | 2. Clinically good (after correction maybe very good) No treatment required | 10.2 Minor hypersensitivity for a limited period of time, normal vitality | 11.2 Small and localized demineralization | 12.2.1 Small marginal enamel fracture (< 150 μm) 12.2.2 Hairline crack in enamel (< 150 μm) |
3. Clinically sufficient/satisfactory (minor shortcomings, no unacceptable effects but not adjustable without damage to the tooth) | 1.3.1 Dull surface but acceptable if covered with film of saliva 1.3.2 Multiple pores on more than one-third of the surface | 2a.3 Moderate surface staining that may also present on other teeth, not esthetically unacceptable 2b.3 Moderate marginal staining, not esthetically unacceptable | 3.3 Distinct deviation but acceptable. Does not affect esthetics: 3.3.1 more opaque 3.3.2 more translucent 3.3.3 darker 3.3.4 brighter | 4.3 Form deviates from the normal but is esthetically acceptable | 3. Clinically sufficient/satisfactory (minor shortcomings, no unacceptable effects but not adjustable without damage to the tooth) | 5.3 Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or proximal contact | 6.3.1 Gap < 250 μm not removable 6.3.2. Several small marginal fractures 6.3.3 Major irregularities, ditching or flash, steps | 7.3 < 50% or 150–300% of corresponding enamel | 8.3. Somewhat weak contact, no indication of damage to tooth, gingiva or periodontal structures; 50 μm metal blade can pass | 9. 3. 1 Marginal gap < 200 μm 9. 3. 2 Negative steps visible < 250 μm. no adverse effects noticed 9.3.3 Poor radiopacity of filling material | 3.Clinically sufficient/satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth) | 10.3.1 Moderate hypersensitivity 10.3.2 Delayed/mild sensitivity; no subjective complaints, no treatment needed | 11.3 Larger areas of demineralization (only preventive measures necessary) | 12.3.1 Marginal enamel defect < 250 μm 12.3.2 Crack < 250 μm 12.3.3 Enamel chipping 12.3.4 Multiple cracks |
4. Clinically unsatisfactory (but reparable) | 1.4.1 Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary 1.4.2 Voids | 2a.4 Unacceptable surface staining on the restoration and major intervention necessary for improvement 2b.4 Pronounced marginal staining; major intervention necessary for improvement | 3.4 Localized clinically deviation that can be corrected by repair: 3.4.1 Too opaque 3.4.2 Too translucent 3.4.3 Too dark 3.4.4 Too bright | 4.4. Form is affected and unacceptable esthetically Intervention/correction is necessary | 4. Clinically unsatisfactory/(but reparable) | 5.4.1 Material chip fractures which damage marginal quality or proximal contacts 5.4.2 Bulk fractures with partial loss (less than half of the restoration) | 6.4.1 Gap > 250 μm or dentine/base exposed 6.4.2. Severe ditching or marginal fractures 6.4.3 Larger irregularities or steps (repair necessary) | 7.4 Restoration > 300% of enamel wear or antagonist > 300% | 8.4 Too weak and possible damage due to food impaction; 100 μm metal blade can pass | 9.4.1 Marginal gap > 250 μm 9.4.2 Cement excess accessible but not removable 9.4.3 Negative steps > 250 μm and repairable | 4. Clinically unsatisfactory (repair for prophylactic reasons) | 10.4.1 Intense hypersensitivity 10.4.2 Delayed with minor subjective symptoms 10.4.3 No clinical detectable sensitivity. Intervention necessary but not replacement | 11. 4 Caries with cavitation and suspected undermining caries (localized and accessible can be repaired) | 12.4.1 Major marginal enamel defects; gap > 250 μm or dentine or base exposed 12.4.2 Large cracks > 250 μm, probe penetrates 12.4.3. Large enamel chipping or wall fracture |
5. Clinically poor (replacement necessary) | 1.5 Very rough, unacceptable plaque retentive surface | 2a.5 Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention 2b.5 Deep marginal staining, not accessible for intervention | 3.5 Unacceptable Replacement necessary | 4.5 Form is unsatisfactory and/or lost. Repair not feasible/reasonable Replacement needed | 5. Clinically poor (replacement necessary) | 5.5 (Partial or complete) loss of restoration or multiple fractures | 6.5.1 Restoration (complete or partial) is loose but in situ 6.5.2 Generalized major gaps or irregularities | 7.5 Restoration or antagonist > 500% of corresponding enamel | 8.5 Too weak and/or clear damage due to food impaction and/or pain/gingivitis | 9.5.1 Secondary caries, large gaps 9.5.2 Apical pathology 9.5.3 Fracture/loss of restoration or tooth | 5. Clinically poor (replacement necessary) | 10.5 Intense, acute pulpitis or non-vital tooth. Endodontic treatment is necessary, and restoration has to be replaced | 11.5 Deep caries or exposed dentine that is not accessible for repair of restoration | 12.5. Cusp or tooth fracture |
Evaluation methods
Occlusal wear evaluation
Statistical analysis
Results
Category | Score | Baseline (n = 40) | 6-month (n = 40) | 12-month (n = 40) | 18-month (n = 40) | 24-month (n = 40) | FU $ | QF $ | TNB $ | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FU | QF | TNB | FU | QF | TNB | FU | QF | TNB | FU | QF | TNB | FU | QF | TNB | ||||||
Esthetic properties | Surface luster | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 39 | 40 | 40 | 38 | 38 | 40 | 37 | 38 | 40 | |||
2 | - | - | - | - | - | - | 1 | - | - | 2 | 2 | - | 3 | 2 | - | p2 = 0.317 | ||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p3 = 0.157 | p3 = 0.157 | |||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.083 | p4 = 0.157 | |||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | p = 0.368 | p = 0.358 | p = 0.235 | |||||||||||||||||
Staining: (a)margin | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 38 | 38 | 39 | 38 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | 2 | 2 | 1 | 2 | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.157 | p4 = 0.317 | p3 = 0.157 | ||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.157 | ||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | p = 0.133 | p = 0.813 | ||||||||||||||||||
Staining: (b)surface | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | ||||||||||||||||||||
Color match and translucency | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 38 | 40 | 40 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | - | 2 | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.157 | ||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | p = 0.133 | |||||||||||||||||||
Esthetic anatomical form | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | ||||||||||||||||||||
Functional properties | Fracture of material and retention | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | |||
2 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | ||||||||||||||||||||
Marginal adaptation | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 39 | 40 | 39 | 37 | 38 | ||||
2 | - | - | - | - | - | - | - | - | - | - | 1 | - | 1 | 3 | 2 | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.317 | p3 = 0.317 | p4 = 0.157 | ||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.083 | ||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | p = 0.368 | p = 0.593 | ||||||||||||||||||
Occlusal wear | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 39 | 40 | 40 | 38 | 40 | 40 | ||||
2 | - | - | - | - | - | - | - | - | - | 1 | - | - | 2 | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p3 = 0.317 | ||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.157 | ||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | p = 0.368 | p = 0.133 | ||||||||||||||||||
Proximal contact | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | ||||||||||||||||||||
Radiographic examination | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | ||||||||||||||||||||
Biological properties | Post-operative sensitivity | 1 | 38 | 39 | 37 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | |||
2 | 2 | 1 | 3 | - | - | - | - | - | - | - | - | - | - | - | - | p1 = 0.157 | p1 = 0.317 | p1 = 0.083 | ||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p2 = 0.157 | p2 = 0.317 | p2 = 0.083 | ||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p3 = 0.157 | p3 = 0.317 | p3 = 0.083 | ||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.157 | p4 = 0.317 | p4 = 0.083 | ||
# | p = 0.593 | |||||||||||||||||||
Recurrent caries | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 39 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 1 | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | p4 = 0.317 | ||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# | p = 0.368 | |||||||||||||||||||
Tooth integrity | 1 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | 40 | ||||
2 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
4 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
5 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
# |