The Effect of Coenzyme Q10/Collagen Hydrogel on Bone Regeneration in Extraction Socket Prior to Implant Placement in Type II Diabetic Patients: A Randomized Controlled Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethical Approval and Registration
2.2. Sample Size Calculation
2.3. Study Participants
2.4. Inclusion and Exclusion Criteria
2.5. Randomization and Allocation Concealment
2.6. Preparation of the CoQ10/Collagen Thermoresponsive Hydrogel
2.7. Evaluation of Gelation Behaviour
2.8. In-Vitro Release of CoQ10
2.9. Swelling Ratio (SR)
2.10. Pre-Surgical Procedures
2.11. Extraction of Teeth
2.12. Post-Operative Care
2.13. Pain and Post-Extraction Complication Assessment
2.14. Cone Beam Computed Tomography (CBCT) Acquisition
2.15. Radiographic Evaluation
2.16. Presurgical Planning for Implant Site
2.17. Bone Collection during Implant Surgery
2.18. Implant Placement Surgery
2.19. Measurement of Implant Stability
2.20. RNA Isolation and Pooled RNA Quantification
2.21. Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) of Osteogenic Genes
2.22. Histological Examination
2.23. Histomorphometric Analysis
2.24. Primary and Secondary Outcomes
2.25. Statistical Analysis
3. Results
3.1. Evaluation of Gelation Behavior
3.2. In-Vitro Release of CoQ10
3.3. Swelling Ratio
4. Clinical Outcomes
4.1. Assessment of Post-Extraction Socket Healing and Pain
4.2. Implant Stability
4.3. Radiographic Outcomes
4.3.1. Bone Density
4.3.2. Bone Linear Outcomes
4.3.3. Bone Volume of the Extraction Socket
4.4. Gene Expression Analysis
4.5. Histological Analysis
4.6. Histomorphometric Outcomes
5. Discussion
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
Mankowski Pain Scale | ||
---|---|---|
0 | Pain Free | No medication needed. |
1 | Very minor annoyance—occasional minor twinges. | No medication needed. |
2 | Minor annoyance—occasional strong twinges. | No medication needed. |
3 | Annoying enough to be distracting. | Mild painkillers are effective. (Aspirin, Ibuprofen.) |
4 | Can be ignored if you are really involved in your work, but still distracting. | Mild painkillers relieve pain for 3–4 h. |
5 | Can’t be ignored for more than 30 min. | Mild painkillers reduce pain for 3–4 h. |
6 | Can’t be ignored for any length of time, but you can still go to work and participate in social activities. | Stronger painkillers (Codeine, Vicodin) reduce pain for 3–4 h. |
7 | Makes it difficult to concentrate, interferes with sleep You can still function with effort. | Stronger painkillers are only partially effective. Strongest painkillers relieve pain (Oxycontin, Morphine) |
8 | Physical activity severely limited. You can read and converse with effort. Nausea and dizziness set in as factors of pain. | Stronger painkillers are minimally effective. Strongest painkillers reduce pain for 3–4 h. |
9 | Unable to speak. Crying out or moaning uncontrollably—near delirium. | Strongest painkillers are only partially effective. |
10 | Unconscious. Pain makes you pass out. | Strongest painkillers are only partially effective. |
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Variable | Control | Collagen | CoQ10 | p-Value |
---|---|---|---|---|
At Insertion | ||||
Mean ± SD | 61.83 ± 4.91 | 56.60 ± 7.58 | 61.13 ± 8.29 | 0.168 |
95% CI | 49.64, 74.02 | 47.19, 66.01 | 47.93, 74,32 | |
Median (IQR) | 59.00 | 55.00 | 57.50 | |
At three Months | 52.2 ± 0.74 | 53.8 ± 2.17 | 56.6 ± 2.39 | |
Mean ± SD | 52.17 ± 5.97 | 53.80 ± 6.75 | 56.63 ± 7.75 | 0.304 |
95% CI | 37.35, 66.98 | 45.42, 62.18 | 44.30, 68.95 | |
Median | 49.50 | 50.25 | 53.63 |
Variable | Control | Collagen | CoQ10 | p-Value |
---|---|---|---|---|
Bone Density (Mean Grey Value) | ||||
Mean ± SD | 6.33 ± 1.17 | 6.52 ± 1.91 | 18.93 ± 7.28 | 0.003 * |
95% CI | 5.10, 7.56 | 4.52, 8.52 | 11.28, 26.57 | |
Median (IQR) | 5.84 (2.24) | 6.56 (3.32) | 17.23 (13.26) | |
Percentage of Bone formation in the extraction socket | ||||
Mean ± SD | 7.52 ± 1.58 | 7.73 ± 2.38 | 22.38 ± 7.85 | 0.003 * |
95% CI | 5.86, 9.17 | 5.24, 10.23 | 14.14, 30.61 | |
Median (IQR) | 7.20 (3.08) | 7.51 (4.33) | 19.3 (13.15) | |
Difference in height of buccal plate of bone (mm) | ||||
Mean ± SD | 2.54 ± 0.13 | 1.99 ± 0.90 | 0.92 ± 0.69 | 0.011 * |
95% CI | 2.17, 2.92 | 1.04, 2.94 | 0.19, 1.65 | |
Median (IQR) | 2.62 (0.63) | 1.86 (1.67) | 0.82 (1.27) | |
Difference in height of lingual plate of bone (mm) | ||||
Mean ± SD | 1.24 ± 0.21 | 1.41 ± 0.51 | 1.09 ± 0.38 | 0.493 |
95% CI | 1.03, 1.46 | 0.88, 1.95 | 0.69, 1.49 | |
Median (IQR) | 1.30 (0.42) | 1.39 (0.97) | 1.00 (0.78) | |
Difference in width of socket at 1 mm from alveolar crest(mm) | ||||
Mean ± SD | 1.36 ± 0.52 | 1.31 ± 0.58 | 1.07 ± 0.58 | 0.700 |
95% CI | 0.82, 1.91 | 0.70, 1.92 | 0.46, 1.68 | |
Median (IQR) | 1.36 (1.05) | 1.30 (0.81) | 1.07 (1.02) | |
Difference in width of socket at 3 mm from alveolar crest (mm) | ||||
Mean ± SD | 1.22 ± 0.28 | 1.14 ± 0.73 | 0.93 ± 0.44 | 0.644 |
95% CI | 0.93, 1.51 | 0.37, 1.91 | 0.48, 1.39 | |
Median (IQR) | 1.20 (0.49) | 0.98 (1.48) | 0.87 (0.92) | |
Difference in width of socket at 5 mm from alveolar crest (mm) | ||||
Mean ± SD | 0.87 ± 0.35 | 0.73 ± 0.81 | 0.47 ± 0.29 | 0.262 |
95% CI | 0.50, 1.24 | 0.12, 1.58 | 0.17, 0.77 | |
Median (IQR) | 0.86 (0.73) | 0.43 (1.15) | 0.40 (0.40) | |
Volume of the extraction socket immediate after extraction | ||||
Mean ± SD | 79.36 ± 46.42 | 106.76 ± 63.90 | 115.69 ± 66.28 | 0.548 |
95% CI | 30.64, 128.07 | 39.71, 173.82 | 46.14, 185.25 | |
Median (IQR) | 72.43 (58.88) | 93.73 (125.96) | 99.67 (133.82) | |
Volume of the extraction socket at three months | ||||
Mean ± SD | 43.03 ± 20.16 | 69.53 ± 37.33 | 54.47 ± 25.39 | 0.348 |
95% CI | 21.88, 64.19 | 30.36, 108.70 | 27.82, 81.12 | |
Median (IQR) | 37.22 (37.70) | 68.13 (58.10) | 48.70 (38.26) |
Variable | Control | Collagen | CoQ10 | p-Value |
---|---|---|---|---|
Percentage of bone formed | ||||
Mean ± SD | 34.56 ± 8.34 | 46.00 ± 9.70 | 68.93 ± 9.38 | 0.001 * |
95% CI | 26.84, 42.27 | 37.02, 54.97 | 60.26, 77.60 | |
Median (IQR) | 33.47 (9.36) | 48.98 (12.10) | 65.11 (11.89) | |
Percentage of fibrous tissue formed | ||||
Mean ± SD | 34.89 ± 3.07 | 27.24 ± 6.86 | 12.96 ± 1.21 | 0.009 * |
95% CI | 30.01, 39.78 | 20.89, 33.59 | 11.03, 14.88 | |
Median (IQR) | 33.83 (5.0) | 24.73 (13.0) | 13.05 (2.0) |
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Ghanem, M.; Heikal, L.; Abdel Fattah, H.; El Ashwah, A.; Fliefel, R. The Effect of Coenzyme Q10/Collagen Hydrogel on Bone Regeneration in Extraction Socket Prior to Implant Placement in Type II Diabetic Patients: A Randomized Controlled Clinical Trial. J. Clin. Med. 2022, 11, 3059. https://doi.org/10.3390/jcm11113059
Ghanem M, Heikal L, Abdel Fattah H, El Ashwah A, Fliefel R. The Effect of Coenzyme Q10/Collagen Hydrogel on Bone Regeneration in Extraction Socket Prior to Implant Placement in Type II Diabetic Patients: A Randomized Controlled Clinical Trial. Journal of Clinical Medicine. 2022; 11(11):3059. https://doi.org/10.3390/jcm11113059
Chicago/Turabian StyleGhanem, Mostafa, Lamia Heikal, Hagar Abdel Fattah, Adham El Ashwah, and Riham Fliefel. 2022. "The Effect of Coenzyme Q10/Collagen Hydrogel on Bone Regeneration in Extraction Socket Prior to Implant Placement in Type II Diabetic Patients: A Randomized Controlled Clinical Trial" Journal of Clinical Medicine 11, no. 11: 3059. https://doi.org/10.3390/jcm11113059
APA StyleGhanem, M., Heikal, L., Abdel Fattah, H., El Ashwah, A., & Fliefel, R. (2022). The Effect of Coenzyme Q10/Collagen Hydrogel on Bone Regeneration in Extraction Socket Prior to Implant Placement in Type II Diabetic Patients: A Randomized Controlled Clinical Trial. Journal of Clinical Medicine, 11(11), 3059. https://doi.org/10.3390/jcm11113059