Clinical Outcomes and Quantitative Margin Analysis of a Universal Adhesive Using a Randomized Clinical Trial over Three Years
Abstract
:1. Introduction
- Both in clinical evaluation (primary outcome) and quantitative marginal analysis (secondary outcome), SBU has an increased performance when compared to that of OFL (adhesive evaluation, application mode, conformity of methods);
- The marginal gap generally increases with the passing of time (gap progression);
- Quantitative margin analysis identifies group differences before they become visible within clinical evaluation parameters (power of methods).
2. Materials and Methods
2.1. Study Design
2.2. Study Population
2.3. Restorative Procedure
2.4. Manufacture of the Impression
2.5. Replica Production and Mounting for SEM Imaging
2.6. Study Outcomes
2.6.1. Clinical Assessment
2.6.2. Quantitative Margin Analysis
2.7. Statistical Analysis
2.7.1. Clinical Assessment
2.7.2. Quantitative Margin Analysis
3. Results
3.1. Clinical Assessment
3.2. Quantitative Margin Analysis
3.3. Clinic and QMA
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Group | SBU-SE | SBU-SEE | SBU-ER | OFL-ER |
---|---|---|---|---|
NClinic/NQMA | 22/11 | 22/11 | 22/11 | 22/11 |
Adhesive | Scotchbond Universal (SBU) | OptiBond FL (OFL) | ||
Application mode | self-etch (SE) | selective-enamel-etch (SEE) | etch-and-rinse (ER) | etch-and-rinse (ER) |
Composite | nanocomposite Filtek™ Supreme XTE (3M) | |||
Lost restorations | 1 1 | - | - | 5 2 |
Location | ||||
maxilla | 10/4 | 10/5 | 14/7 | 10/6 |
mandible | 12/7 | 12/6 | 8/4 | 12/5 |
Lesion borderline | ||||
enamel | -/- | -/- | -/- | -/- |
dentin | 2/- | 3/1 | 2/2 | 4/2 |
mixed (enamel/dentin) | 20/11 | 19/10 | 20/9 | 18/9 |
Lesion depth | ||||
shallow (<1 mm deep) | -/- | 1/- | -/- | 2/1 |
medium (1–2 mm deep) | 22/11 | 21/11 | 21/11 | 19/10 |
deep (>2 mm) | -/- | -/- | 1/- | 1/- |
Material | Composition | Self-Etch Mode | Selective-Enamel-Etch Mode | Etch-and-Rinse Mode |
---|---|---|---|---|
Scotchbond Universal Etchant a | 35% phosphoric acid | 1. Apply etchant for 30 s on the enamel. 2. Rinse with water for 20 s and dry with water- and oil-free air | ||
Scotchbond Universal a | 10-MDP, HEMA, silane, dimethacrylate resins, Vitrebond™ copolymer, filler, ethanol, water, initiators (LOT 552577) | 1. Actively apply the adhesive to the cavity for 20 s. 2. Gently air-dry the adhesive for approximately 5 s for the solvent to evaporate. 3. Light cure for 10 s (>1000 mW/cm2) 1. | ||
OptiBond FL b | FL primer: HEMA, GPDM, MMEP, water, ethanol, photoinitiator (CQ), BHT FL adhesive: Bis-GMA, HEMA, GPDM, GDMA, photoinitiator (CQ), ODMAB, fillers, barium aluminoborosilicate (LOT 4964258) | 1. Apply etchant for 15 s (dentin 15 s, enamel 30 s). 2. Rinse thoroughly for 15 s; air dry for 3 s (do not overdry). 3. Actively apply the primer for 15 s; air dry for 5 s. 4. Apply adhesive with a light brushing motion for 15 s; air thin for 3 s; light cure for 20 s (>1000 mW/cm2) 1. | ||
Filtek Supreme XTE a | Bis-GMA, UDMA, TEGDMA, Bis-EMA, silanated silica, silanated zirconia, photoinitiators (LOT 552577) | 1. Place restorative in increments. 2. Light cure restorative in increments (body, enamel shades 2.0 mm, 20 s. dentin shades 1.5 mm, 40 s, >1000 mW/cm2) 1. |
SBU-SE | SBU-SEE | SBU-ER | OFL | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
BL | 6 m | 12 m | 24 m | 36 m | BL | 6 m | 12 m | 24 m | 36 m | BL | 6 m | 12 m | 24 m | 36 m | BL | 6 m | 12 m | 24 m | 36 m | |
Restorations assessed, n | 22 | 22 | 22 | 21 | 20 | 22 | 22 | 22 | 21 | 21 | 22 | 22 | 22 | 21 | 21 | 22 | 22 | 21 | 19 | 16 |
Reassessment rate, % | 100 | 100 | 100 | 95.5 | 90.9 | 100 | 100 | 100 | 95.5 | 95.5 | 100 | 100 | 100 | 95.5 | 95.5 | 100 | 100 | 95.5 | 86.4 | 72.7 |
Aesthetic Criteria 1 | ||||||||||||||||||||
Non-acceptable, % | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 5.9 3 | 5.9 3 |
Functional Criteria 1 | ||||||||||||||||||||
Non-acceptable, % | 0.0 | 0.0 | 0.0 | 4.8 4 | 4.8 4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 4.5 4 | 9.1 4 | 19.0 4 | 20.0 4 |
Biological Criteria 1 | ||||||||||||||||||||
Non-acceptable, % | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Cumulative Failure Rate (Total Score) 2 | ||||||||||||||||||||
Non-acceptable, % | 0.0 | 0.0 | 0.0 | 4.8 4 | 4.8 4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 4.5 4 | 9.1 4 | 23.8 5 | 23.8 5 |
Groups | Marginal Staining 1 (Score 2) | Marginal Adaptation 2 (Score 2) | Fractures/Retention 3 (Score 5) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Time | BL | 6 m | 12 m | 24 m | 36 m | BL | 6 m | 12 m | 24 m | 36 m | BL | 6 m | 12 m | 24 m | 36 m | |
SBU SE vs. SEE | % pi | 13.6/4.5 0.5 | 13.6/4.5 0.625 | 18.2/4.5 0.375 | 25/9.5 0.375 | 30/19 0.687 | 0/0 n.c. | 22.7/4.5 0.219 | 36.4/18.2 0.344 | 35/23.8 0.687 | 45/23.8 0.344 | 0/0 n.c. | 0/0 n. c. | 0/0 n. c. | 4.8/0 1.0 | 4.8/0 1.0 |
SBU SE vs.-ER | % pi | 13.6/0 0.25 | 13.6/0 0.25 | 18.2/9.1 0.625 | 25/4.8 0.125 | 30/33.3 1.0 | 0/0 n.c. | 22.7/13 0.687 | 36.4/31.2 1.0 | 35/28.6 1.0 | 45/42.9 1.0 | 0/0 n.c | 0/0 n.c. | 0/0 n.c. | 4.8/0 1.0 | 4.8/0 1.0 |
SBU-SE vs. OFL | % pi | 13.6/4.5 0.5 | 13.6 /19 1.0 | 18.2/ 25 1.0 | 25/29.4 1.0 | 30/41.2 0.687 | 0/0 n.c. | 22.7/28.6 1.0 | 36.4/35 1.0 | 35/37.5 1.0 | 45/56.3 0.453 | 0/0 n.c. | 0/4.5 1.0 | 0/9.1 0.5 | 4.8/20 0.375 | 4.8/20 0.375 |
SBU-SEE vs. ER | % pi | 4.5/0 1.0 | 4.5/0 1.0 | 4.5/9.1 1.0 | 9.5/4.8 1.0 | 19./33.3 0.375 | 0/0 n.c. | 4.5/13.6 0.625 | 18.2/31.2 0.549 | 23.8/28.6 1.0 | 23.8/42.9 0.219 | 0/0 n.c. | 0/0 n.c. | 0/0 n.c. | 0/0 n.c. | 0/0 n.c. |
SBU-SEE vs. OFL | % pi | 4.5/4.5 1.0 | 4.5/19 0.25 | 4.5/25 0.125 | 9.5/29.4 0.25 | 19/41.2 0.063 4 | 0/0 n.c. | 4.5/28.6 0.063 4 | 18.2/35 0.375 | 23.8/37.5 0.453 | 23.8/56.3 0.07 | 0/0 n.c. | 0/4.5 1.0 | 0/9.1 0.5 | 0/20 0.125 | 0/20 0.125 |
SBU-ER vs. OFL | % pi | 0/4.5 1.0 | 0/19.0 0.125 | 9.1/25 0.375 | 4.8/29.4 0.219 | 33.3/41.2 1.0 | 0/0 n.c. | 13.6/28.6 0.375 | 31.2/35 1.0 | 28.6/37.5 0.727 | 42.9/56.3 0.219 | 0/0 n.c. | 0/4.5 1.0 | 0/9.1 0.5 | 0/20 0.125 | 0/20 0.125 |
Groups | Time | CFR, % | Confidence Interval (Prevalence) | ||
---|---|---|---|---|---|
SBU-SE 3 | 24 m | 4.8 | 0.001–0.238 (0.048) | ||
36 m | 4.8 | 0.0013–0.249 (0.050) | |||
SBU-SEE 1 | 24 m | 0.0 | 0.000–0.161 (0.000) | ||
36 m | 0.0 | 0.000–0.161 (0.000) | |||
SBU-ER 2 | 24 m | 0.0 | 0.000–0.161 (0.000) | ||
36 m | 0.0 | 0.000–0.161 (0.000) | |||
OFL 1,2,3 | 24 m | 23.8 | 0.092–0.512 (0.263) | ||
36 m | 23.8 | 0.110–0.587 (0.313) |
Marginal Staining Score 2 1 | ||||||||||
BL-6 m | 6–12 m | 12–24 m | 24–36 m | BL-12 m | BL-24 m | BL-36 m | 6–24 m | 6–36 m | 12–36 m | |
SBU-SE | 1.000 | 1.000 | 0.625 | 1.000 | 1.000 | 0.687 | 0.453 | 0.625 | 0.375 | 0.375 |
SBU-SEE | 1.000 | 1.000 | 1.000 | 0.625 | 1.000 | 1.000 | 0.375 | 1.000 | 0.375 | 0.250 |
SBU-ER | n.c. | 0.500 | 1.000 | 0.031 | 0.500 | 1.000 | 0.016 | 1.000 | 0.016 | 0.125 |
OFL | 0.250 | 0.687 | 1.000 | 0.625 | 0.219 | 0.219 | 0.031 | 0.625 | 0.219 | 0.250 |
Marginal Adaptation Score 2 1 | ||||||||||
BL-6 m | 6–12 m | 12–24 m | 24–36 m | BL-12 m | BL-24 m | BL-36 m | 6–24 m | 6–36 m | 12–36 m | |
SBU-SE | 0.063 * | 0.453 | 1.000 | 0.687 | 0.008 | 0.016 | 0.004 | 0.687 | 0.289 | 0.625 |
SBU-SEE | 1.000 | 0.375 | 1.000 | 1.000 | 0.125 | 0.063 * | 0.063 * | 0.125 | 0.219 | 1.000 |
SBU-ER | 0.250 | 0.125 | 1.000 | 0.375 | 0.016 | 0.031 | 0.004 | 0.375 | 0.031 | 0.250 |
OFL | 0.031 | 0.625 | 1.000 | 0.375 | 0.016 | 0.031 | 0.004 | 0.500 | 0.063 * | 0.125 |
Fractures/Retention Score 5 2 | ||||||||||
BL-6 m | 6–12 m | 12–24 m | 24–36 m | BL-12 m | BL-24 m | BL-36 m | 6–24 m | 6–36 m | 12–36 m | |
SBU-SE | n.c. | n.c. | 1.000 | 1.000 | n.c. | 1.000 | 1.000 | 1.000 | 1.000 | 1.000 |
SBU-SEE | n.c. | |||||||||
SBU-ER | n.c. | |||||||||
OFL | 1.000 | 1.000 | 0.500 | 1.000 | 0.500 | 0.125 | 0.125 | 0.250 | 0.250 | 0.500 |
Time | SBU-SE vs. SBU-SEE | SBU-SE vs. SBU-ER | SBU-SE vs. OFL | SBU-SEE vs. SBU-ER | SBU-SEE vs. OFL | SBU-ER vs. OFL | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
gap, % | pi | % | pi | % | pi | % | pi | % | pi | % | pi | |
BL | 1.4/0.1 | 0.125 | 1.4/1.3 | 0.844 | 1.4/2.9 | 0.831 | 0.1/1.3 | 0.375 | 0.1/2.9 | 0.063 1 | 1.3/2.9 | 0.469 |
6 m | 9.2/2.4 | 0.156 | 9.2/3.5 | 0.156 | 9.2/9.7 | 0.627 | 2.4/3.5 | 0.625 | 2.4/9.7 | 0.023 | 3.5/9.7 | 0.223 |
12 m | 9.6/1.9 | 0.016 | 9.6/6.0 | 0.820 | 9.6/14.6 | 0.557 | 1.9/6.0 | 0.039 | 1.9/14.6 | 0.027 | 6.0/14.6 | 0.275 |
24 m | 12.2/3.2 | 0.016 | 12.2/7.4 | 0.055 1 | 12.2/17.1 | 0.320 | 3.2/7.4 | 0.195 | 3.2/17.1 | 0.006 | 7.4/17.1 | 0.066 1 |
36 m | 19.5/5.5 | 0.007 | 19.5/7.8 | 0.001 | 19.5/29.2 | 0.215 | 5.5/7.8 | 0.742 | 5.5/29.2 | 0.003 | 7.8/29.2 | 0.005 |
Parameter | Times | SBU-SE | SBU-SEE | SBU-ER | OFL |
---|---|---|---|---|---|
gap | BL vs. 6 m | 0.016 | 0.125 | 0.063 1 | 0.008 |
BL vs. 12 m | 0.008 | 0.063 1 | 0.016 | 0.008 | |
BL vs. 24 m | 0.008 | 0.063 1 | 0.016 | 0.004 | |
BL vs. 36 m | 0.001 | 0.031 | 0.016 | 0.002 | |
6 m vs. 12 m | 1.000 | 0.844 | 0.016 | 0.063 1 | |
6 m vs. 24 m | 0.023 | 0.438 | 0.016 | 0.004 | |
6 m vs. 36 m | 0.001 | 0.297 | 0.078 | 0.002 | |
12 m vs. 24 m | 0.008 | 0.313 | 0.297 | 0.004 | |
12 m vs. 36 m | 0.001 | 0.156 | 0.547 | 0.002 | |
24 m vs. 36 m | 0.001 | 0.094 | 0.578 | 0.002 |
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Haak, R.; Werner, M.S.; Schneider, H.; Häfer, M.; Schulz-Kornas, E. Clinical Outcomes and Quantitative Margin Analysis of a Universal Adhesive Using a Randomized Clinical Trial over Three Years. J. Clin. Med. 2022, 11, 6910. https://doi.org/10.3390/jcm11236910
Haak R, Werner MS, Schneider H, Häfer M, Schulz-Kornas E. Clinical Outcomes and Quantitative Margin Analysis of a Universal Adhesive Using a Randomized Clinical Trial over Three Years. Journal of Clinical Medicine. 2022; 11(23):6910. https://doi.org/10.3390/jcm11236910
Chicago/Turabian StyleHaak, Rainer, Melissa Sophie Werner, Hartmut Schneider, Matthias Häfer, and Ellen Schulz-Kornas. 2022. "Clinical Outcomes and Quantitative Margin Analysis of a Universal Adhesive Using a Randomized Clinical Trial over Three Years" Journal of Clinical Medicine 11, no. 23: 6910. https://doi.org/10.3390/jcm11236910