Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Population and Setting
2.3. Sample Size Calculation
2.4. Inclusion Criteria
- Male or female, 30–60 years old.
- With diagnosis of peri-implant mucositis.
- Plaque index (PI) ≥ 40%.
- Al least one implant site with PPD ≥ 4 mm, BoP+ and suppuration.
- No uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus, and systemic lupus erythematosus).
- No pharmacological therapies, no chemo-radiotherapies.
- No smoking (>10 cigarettes/day), alcohol, and/or drug consumption.
- No pregnancy or breastfeeding.
- No allergies.
2.5. Randomized Allocation
2.6. Blinding
2.7. Patient Dataset and Periodontal Charting
2.8. Duration of the Study and Times of Follow Up
2.9. Salivary SAT-Test Assessment
- <1000 mEq/L: High Deficiency
- 1000–1500 mEq/L: Optimal Values
- 1500–2000 mEq/L: Normal Values
- 2000–2500 mEq/L: Borderline Values
- >2500 mEq/L: Possible ongoing inflammation
2.10. Description of the Bioptron Light Therapy
2.11. Professional Mechanical Debridement: Clinical Procedure
2.12. D-BioTECH Approach
2.13. Co-Intervention
2.14. Statistical Analysis
3. Results
3.1. Population Characteristics
3.2. Plaque Index
3.3. Probing Pocket Depth
3.4. Salivary Sat Test
3.5. BoP
3.6. Pain Intensity Reduction
3.7. Influence of Patients’ Characteristics
4. Discussion
Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Study Group | Control Group | |||||||
---|---|---|---|---|---|---|---|---|
Min | Max | Mean | SD | Min | Max | Mean | SD | |
Age (yrs) | 36 | 74 | 56.7 | 9.131 | 29 | 76 | 51.2 | 10.94 |
BMI (kg/m2) | 17.55 | 34.43 | 25.62 | 4.777 | 20.75 | 35 | 27.17 | 4.303 |
DMFT | 9 | 24 | 17.35 | 5.071 | 5 | 24 | 14.2 | 5.845 |
Plaque Index | ||||||||
T0 | 40% | 90% | 64% | 12% | 20% | 76% | 52% | 16% |
T1 | 10% | 60% | 34% | 14% | 15% | 50% | 33% | 9% |
T2 | 10% | 50% | 27% | 10% | 20% | 60% | 31% | 9% |
T3 | 10% | 38% | 23% | 9% | 20% | 40% | 29% | 6% |
PPD (mm) | ||||||||
T0 | 3 | 7 | 4.317 | 1.101 | 2.667 | 5.167 | 3.858 | 0.674 |
T1 | 2 | 6.833 | 3.633 | 1.148 | 2.667 | 5 | 3.542 | 0.642 |
T2 | 2 | 6 | 3.375 | 1.079 | 2.5 | 5 | 3.433 | 0.685 |
T3 | 2 | 6 | 3.275 | 1.041 | 2.333 | 5 | 3.375 | 0.658 |
SAT test (mEq/L) | ||||||||
T0 | 254 | 1325 | 674.7 | 330.1 | 271 | 1217 | 663.3 | 248.2 |
T1 | 326 | 1120 | 592.8 | 221.7 | 320 | 1235 | 694.2 | 238.2 |
T2 | 375 | 993 | 598.5 | 187.8 | 342 | 1188 | 680.5 | 211.8 |
T3 | 423 | 997 | 604.5 | 168.1 | 312 | 1201 | 705.7 | 202.7 |
Study Group | Control Group | |||
---|---|---|---|---|
Gender | F: 8 | M: 12 | F: 9 | M: 11 |
Smoking | No: 11 | Yes: 9 | No: 13 | Yes: 7 |
BoP | ||||
T0 | 20 | 20 | ||
T1 | 4 | 8 | ||
T2 | 0 | 9 | ||
T3 | 0 | 8 |
Time Interval | Study Group | Control Group | p | 95% CI | ||
---|---|---|---|---|---|---|
Mean | SD | Mean | SD | |||
[T0; T1] | −29.85 | 11.55 | −19.05 | 15.48 | 0.017 * | (−19.56, −2.036) |
[T1; T2] | −6.60 | 10.92 | −2.75 | 7.525 | 0.203 | (−9.877, 2.177) |
[T2; T3] | −4.25 | 7.926 | −2.00 | 6.959 | 0.346 | (−7.027, 2.527) |
[T0; T3] | −40.70 | 13.03 | −23.80 | 15.88 | 0.001 * | (−26.21, −7.587) |
Time Interval | Study Group | Control Group | p | 95% CI | ||
---|---|---|---|---|---|---|
Mean | SD | Mean | SD | |||
[T0; T1] | −0.683 | 0.415 | −0.317 | 0.390 | 0.006 * | (−0.624, −0.109) |
[T1; T2] | −0.258 | 0.278 | −0.108 | 0.098 | 0.032 * | (−0.286, −0.014) |
[T2; T3] | −0.100 | 0.137 | −0.058 | 0.189 | 0.431 | (−0.148, 0.064) |
[T0; T3] | −1.042 | 0.393 | −0.483 | 0.389 | <0.001 * | (−0.809, −0.308) |
Time Interval | Study Group | Control Group | p | 95% CI | ||
---|---|---|---|---|---|---|
Mean | SD | Mean | SD | |||
[T0; T1] | −81.9 | 221.1 | 30.95 | 111.5 | 0.051 | (−226.3, 0.5644) |
[T1; T2] | 5.75 | 61.24 | −13.70 | 64.96 | 0.336 | (−20.97, 59.87) |
[T2; T3] | 5.95 | 53.98 | 25.15 | 54.36 | 0.269 | (−53.88, 15.48) |
[T0; T3] | −70.2 | 259.2 | 42.4 | 132.6 | 0.095 | (−245.9, 20.67) |
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Nardi, G.M.; Mazur, M.; Papa, G.; Petruzzi, M.; Grassi, F.R.; Grassi, R. Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial. Int. J. Environ. Res. Public Health 2022, 19, 5682. https://doi.org/10.3390/ijerph19095682
Nardi GM, Mazur M, Papa G, Petruzzi M, Grassi FR, Grassi R. Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial. International Journal of Environmental Research and Public Health. 2022; 19(9):5682. https://doi.org/10.3390/ijerph19095682
Chicago/Turabian StyleNardi, Gianna Maria, Marta Mazur, Giulio Papa, Massimo Petruzzi, Felice Roberto Grassi, and Roberta Grassi. 2022. "Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial" International Journal of Environmental Research and Public Health 19, no. 9: 5682. https://doi.org/10.3390/ijerph19095682
APA StyleNardi, G. M., Mazur, M., Papa, G., Petruzzi, M., Grassi, F. R., & Grassi, R. (2022). Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial. International Journal of Environmental Research and Public Health, 19(9), 5682. https://doi.org/10.3390/ijerph19095682