Clinical and Technical Validation of Novel Bite Force Measuring Device for Functional Analysis after Mandibular Reconstruction
Abstract
:1. Introduction
2. Materials and Methods
2.1. Bite Force Measuring Sensor
2.2. Validation Measurements
- “Pure”: no silicone layer (Figure 4A);
- “2-soft”: 2.0 mm silicone layer (S1, A-silicone, bisico, Bielefeld, Germany) on both sides of the device with a final hardness of approximately 72 Shore A (Figure 4B);
- “7-soft”: 7.0 mm silicone layer (S1, A-silicone, bisico, Bielefeld, Germany) on both sides of the device with a final hardness of approximately 72 Shore A (Figure 4C);
- “2-hard”: 2.0 mm silicone layer (Regidur® i, A-silicone, bisico, Bielefeld, Germany) on both sides of the device with a final hardness of approximately 90 Shore A (Figure 4D).
2.3. Study Design
2.4. Clinical Methodology
2.5. Statistical Analysis
3. Results
3.1. Validation Measurements
3.2. Clinical Application
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Set Load (N) | Pure (Linear) | Pure (Cyclic) | 2-Soft (Linear) | 2-Soft (Cyclic) | 7-Soft (Linear) | 7-Soft (Cyclic) | 2-Hard (Linear) | 2-Hard (Cyclic) | 2-Soft (Old) (Cyclic) |
---|---|---|---|---|---|---|---|---|---|
Measured load by force device (absolute values (N)) | |||||||||
50 | 47.5 | 49.0 | 47.0 | 49.0 | 49.0 | 48.0 | 50.0 | 49.0 | 47.0 |
100 | 97.0 | 97.0 | 97.0 | 97.5 | 100 | 95.5 | 100 | 96.5 | 94.0 |
150 | 147.5 | 145.0 | 148.0 | 146.0 | 149.5 | 146.5 | 150 | 144.0 | 144.0 |
200 | 198.5 | 194.5 | 198.5 | 196.5 | 200.5 | 195.5 | 200 | 193.0 | 194.5 |
250 | 249.5 | 244.0 | 249.0 | 247.0 | 252.0 | 247.5 | 247.5 | 241.0 | 243.5 |
300 | 300.5 | 290.0 | 300.0 | 293.5 | 302.0 | 297.5 | 295.0 | 285.5 | 294.5 |
350 | 351.0 | 337.0 | 350.0 | 342.5 | 353.5 | 348.5 | 342.5 | 332.0 | 343.0 |
400 | 401.0 | 381.5 | 400.0 | 388.5 | 404.5 | 399.5 | 389.5 | 375.5 | 393.0 |
450 | 450.5 | 427.0 | 451.5 | 436.5 | 454.5 | 447.0 | 434.0 | 421.0 | 441.5 |
500 | 501.0 | 469.5 | 501.0 | 482.0 | 504.0 | 496.5 | 479.5 | 463.0 | 486.5 |
550 | 545.5 | 514.0 | 549.0 | 529.5 | 553.5 | 543.5 | 523.0 | 506.5 | 533.0 |
600 | 591.5 | 555.5 | 595.5 | 572.5 | 603.5 | 592.5 | 563.5 | 546.5 | 575.5 |
Relative deviations from set load (%) | |||||||||
50 | 5.00 | 2.00 | 6.00 | 2.00 | 2.00 | 4.00 | 0.00 | 2.00 | 6.00 |
100 | 3.00 | 3.00 | 3.00 | 2.50 | 0.00 | 4.50 | 0.00 | 3.50 | 6.00 |
150 | 1.67 | 3.33 | 1.33 | 2.67 | 0.33 | 2.33 | 0.00 | 4.00 | 4.00 |
200 | 0.75 | 2.75 | 0.75 | 1.75 | 0.25 | 2.25 | 0.00 | 3.50 | 2.75 |
250 | 0.20 | 2.40 | 0.40 | 1.20 | 0.80 | 1.00 | 1.00 | 3.60 | 2.60 |
300 | 0.17 | 3.33 | 0.00 | 2.17 | 0.67 | 0.83 | 1.67 | 4.83 | 1.83 |
350 | 0.29 | 3.71 | 0.00 | 2.14 | 1.00 | 0.43 | 2.14 | 5.14 | 2.00 |
400 | 0.25 | 4.63 | 0.00 | 2.88 | 1.13 | 0.12 | 2.63 | 6.13 | 1.75 |
450 | 0.11 | 5.11 | 0.33 | 3.00 | 1.00 | 0.67 | 3.56 | 6.44 | 1.89 |
500 | 0.20 | 6.10 | 0.20 | 3.60 | 0.80 | 0.70 | 4.10 | 7.40 | 2.70 |
550 | 0.82 | 6.55 | 0.18 | 3.73 | 0.64 | 1.18 | 4.91 | 7.91 | 3.09 |
600 | 1.42 | 7.42 | 0.75 | 4.58 | 0.58 | 1.25 | 6.08 | 8.92 | 4.08 |
Mean 600 | 1.16 | 4.19 | 1.08 | 2.68 | 0.77 | 1.61 | 2.17 | 5.28 | 3.22 |
Patient | Edentulous? | Bite Force (N) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Preoperative | Postoperative | Difference Postop.max − Preop.max | ||||||||
1 | 2 | 3 | Maximum | 1 | 2 | 3 | Maximum | |||
1 | No | 39.5 | 45.0 | 43.5 | 45.0 | 44.5 | 37.0 | 40.0 | 44.5 | −0.5 |
2 | No | 380.0 | 387.5 | 411.0 | 411.0 | 271.5 | 281.0 | 282.5 | 282.5 | −128.5 |
3 | No | 292.0 | 335.5 | 315.0 | 335.5 | 162.5 | 164.5 | 180.0 | 180.0 | −155.5 |
4 | Yes | 113.0 | 109.5 | 120.0 | 120.0 | 57.0 | 59.5 | 59.5 | 59.5 | −60.5 |
5 | Yes | 40.0 | 46.5 | 48.5 | 48.5 | 38.5 | 38.0 | 41.0 | 38.5 | −7.5 |
6 | No | 62.0 | 101.0 | 127.5 | 127.5 | 90.5 | 111.0 | 131.5 | 131.5 | 4.0 |
7 | No | 336.0 | 323.5 | 352.5 | 352.5 | 258.5 | 226.5 | 237.5 | 258.5 | −94.0 |
8 | No | 173.0 | 249.0 | 248.5 | 249.0 | 60.0 | 60.5 | 71.5 | 71.5 | −177.5 |
9 | No | 506.0 | 554.5 | 673.5 | 673.5 | 53.0 | 47.5 | 115.0 | 115.0 | −558.5 |
10 | No | 285.0 | 339.0 | 366.5 | 366.5 | 43.5 | 104.0 | 130.5 | 130.5 | −236.0 |
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Steffen, C.; Duda, K.; Wulsten, D.; Voss, J.O.; Koerdt, S.; Nahles, S.; Heiland, M.; Checa, S.; Rendenbach, C. Clinical and Technical Validation of Novel Bite Force Measuring Device for Functional Analysis after Mandibular Reconstruction. Diagnostics 2023, 13, 586. https://doi.org/10.3390/diagnostics13040586
Steffen C, Duda K, Wulsten D, Voss JO, Koerdt S, Nahles S, Heiland M, Checa S, Rendenbach C. Clinical and Technical Validation of Novel Bite Force Measuring Device for Functional Analysis after Mandibular Reconstruction. Diagnostics. 2023; 13(4):586. https://doi.org/10.3390/diagnostics13040586
Chicago/Turabian StyleSteffen, Claudius, Katharina Duda, Dag Wulsten, Jan O. Voss, Steffen Koerdt, Susanne Nahles, Max Heiland, Sara Checa, and Carsten Rendenbach. 2023. "Clinical and Technical Validation of Novel Bite Force Measuring Device for Functional Analysis after Mandibular Reconstruction" Diagnostics 13, no. 4: 586. https://doi.org/10.3390/diagnostics13040586