Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
Ключови думи
Резюме
Описание
Current treatments of periodontitis have limited efficacy since they fail to suppress microorganisms satisfactorily over time. The aim of present study was to investigate whether there are differences between initial treatment of chronic periodontitis (SRP) and SRP in conjunction with injectable platelet-rich fibrin (i-PRF) application.
Thirty patients with chronic periodontitis who had at least two sites with perriodontal pocket depth (PPD) ≥ 4 mm on contralateral side will be involved in the study. Using a split-mouth design, patients will be treated with SRP + I-PRF -(test group) or SRP only-(control group). Gingival crevicular fluid (GCF) and subgingival plaque will be collected with paper points (DentsplyMaillefer, Tulsa, Oklahoma, USA) at baseline and 1, 3 and 6 months after the treatment. The presence and concentrations of Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Tannerella forsythia(Tf) will be analyzed by real-time polymerase chain reaction (qPCR). Periodontal parameters, including bleeding on probing (BOP), probing pocket depth (PPD) and the clinical attachment level (CAL), will be recorded on both sides, as well as concentration of TNF-alpha (tumor necrosis factor alpha), ALP(alkaline phosphatase) and MMP-8 (matrix-metalloproteinase-8).
Дати
| Последна проверка: | 06/30/2020 |
| Първо изпратено: | 11/20/2019 |
| Очаквано записване подадено: | 11/24/2019 |
| Първо публикувано: | 11/25/2019 |
| Изпратена последна актуализация: | 07/08/2020 |
| Последна актуализация публикувана: | 07/12/2020 |
| Дата на първите подадени резултати: | 03/28/2020 |
| Дата на първите подадени резултати от QC: | 05/27/2020 |
| Дата на първите публикувани резултати: | 06/10/2020 |
| Действителна начална дата на проучването: | 10/01/2019 |
| Приблизителна дата на първично завършване: | 06/28/2020 |
| Очаквана дата на завършване на проучването: | 07/08/2020 |
Състояние или заболяване
Интервенция / лечение
Drug: SRP + Injectable Platelet-Rich Fibrin
Drug: SRP + placebo
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: SRP + Injectable Platelet-Rich Fibrin Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin | Drug: SRP + Injectable Platelet-Rich Fibrin Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing |
| Placebo Comparator: SRP + placebo Scaling and root planing in conjunction with saline | Drug: SRP + placebo Saline application during scaling and root planing |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 20 Years Да се 20 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - A minimum of 6 teeth per quadrant; - A minimum of 2 teeth in each quadrant with a probing depth (PD) ≥5 mm; - Bleeding on probing (BOP) had to be at ≥40% tooth sites; - No involvement of furcation; - Good general health. Exclusion Criteria: - Periodontal therapy within last 12 months; - Having surgical therapy; - Use of antibiotics over the last 6 months; - Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis; - Pregnancy or nursing; - Current and former smokers. |
Резултат
Първични изходни мерки
1. Periodontal Pocket Depth-PPD [baseline measure (before the intervention)]
2. Periodontal Pocket Depth-PPD - 1m [after 1 month]
3. Periodontal Pocket Depth-PPD - 3m [after 3 months]
4. Periodontal Pocket Depth-PPD - 6 [after 6 months]
5. Level of Gingival Margin-LGM [baseline measure (before the intervention)]
6. Level of Gingival Margin-LGM - 1m [after 1 month]
7. Level of Gingival Margin-LGM - 3m [after 3 months]
8. Level of Gingival Margin-LGM - 6m [after 6 months]
9. Clinical Attachment Level- CAL [baseline measure (before the intervention)]
10. Clinical Attachment Level- CAL - 1m [after 1 month]
11. Clinical Attachment Level- CAL - 3m [after 3 months]
12. Clinical Attachment Level- CAL - 6m [after 6 months]
13. Bleeding on Probing-BOP [baseline measure (before the intervention)]
14. Bleeding on Probing-BOP - 1m [after 1 month]
15. Bleeding on Probing-BOP 3m [after 3 months]
16. Bleeding on Probing-BOP - 6m [after 6 months]
17. Plaque Index- PI [baseline measure (before the intervention)]
18. Plaque Index- PI -1m [after 1 month]
19. Plaque Index- PI -3m [after 3 months]
20. Plaque Index- PI - 6m [after 6 months]
21. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) [baseline measure (before the intervention)]
22. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m [after 1 month]
23. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m [after 3 months]
24. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m [after 6 months]
25. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) [baseline measure (before the intervention)]
26. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m [after 1 month]
27. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m [after 3 months]
28. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m [after 6 months]
29. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) [baseline measure (before the intervention)]
30. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m [after 1 month]
31. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m [after 3 months]
32. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m [after 6 months]
33. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) [baseline measure (before the intervention)]
34. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m [after 1 month]
35. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m [after 3 months]
36. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m [after 6 months]
37. Periodontal Pocket Microorganisms [baseline measure (before the intervention)]
38. Periodontal Pocket Microorganisms -1m [after 1 month]
39. Periodontal Pocket Microorganisms - 3m [after 3 months]
40. Periodontal Pocket Microorganisms - 6m [after 6 months]
41. Tumor Necrosis Factor Alpha-TNF-α [baseline measure (before the intervention)]
42. Tumor Necrosis Factor Alpha-TNF-α -1m [after 1 month]
43. Tumor Necrosis Factor Alpha-TNF-α - 3m [after 3 months]
44. Tumor Necrosis Factor Alpha-TNF-α -6m [after 6 months]
45. Matrix Metalloproteinase 8 - MMP-8 [baseline measure (before the intervention)]
46. Matrix Metalloproteinase 8 - MMP-8 -1m [after 1 month]
47. Matrix Metalloproteinase 8 - MMP-8 - 3m [after 3 months]
48. Matrix Metalloproteinase 8 - MMP-8 - 6m [after 6 months]
49. Alkaline Phosphatase - ALP [baseline measure (before the intervention)]
50. Alkaline Phosphatase - ALP -1m [after 1 month]
51. Alkaline Phosphatase - ALP -3m [after 3 months]
52. Alkaline Phosphatase - ALP -6m [after 6 months]
