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Completed

NCT Number: NCT04178590

Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SRP + Injectable Platelet-Rich Fibrin

Drug

Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing

Other names: SRP + i-PRF

SRP + placebo

Drug

Saline application during scaling and root planing

Other names: SRP + saline

Primary outcomes

  1. Periodontal Pocket Depth-PPD

    Time frame: baseline measure (before the intervention)

    assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

  2. Periodontal Pocket Depth-PPD - 1m

    Time frame: after 1 month

    assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

  3. Periodontal Pocket Depth-PPD - 3m

    Time frame: after 3 months

    assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

  4. Periodontal Pocket Depth-PPD - 6

    Time frame: after 6 months

    assessment of periodontal pocket depth by probing mean value of one side of the jaw

  5. Level of Gingival Margin-LGM

    Time frame: baseline measure (before the intervention)

    assessment of level of gingival margin-LGM by probing, i.e.distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw

  6. Level of Gingival Margin-LGM - 1m

    Time frame: after 1 month

    assessment of level of gingival margin-LGM by probing, i.e.distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw

  7. Level of Gingival Margin-LGM - 3m

    Time frame: after 3 months

    assessment of level of gingival margin-LGM by probing, i.e. distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva); mean value of one side of the jaw

  8. Level of Gingival Margin-LGM - 6m

    Time frame: after 6 months

    assessment of level of gingival margin-LGM by probing, distance between cementoenamel junction and gingival margin (the most coronal point of the gingiva) after 6 months

  9. Clinical Attachment Level- CAL

    Time frame: baseline measure (before the intervention)

    assessment of clinical attachment level- CAL by probing

  10. Clinical Attachment Level- CAL - 1m

    Time frame: after 1 month

    assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

  11. Clinical Attachment Level- CAL - 3m

    Time frame: after 3 months

    assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

  12. Clinical Attachment Level- CAL - 6m

    Time frame: after 6 months

    assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

  13. Bleeding on Probing-BOP

    Time frame: baseline measure (before the intervention)

    assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).

  14. Bleeding on Probing-BOP - 1m

    Time frame: after 1 month

    assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).

  15. Bleeding on Probing-BOP 3m

    Time frame: after 3 months

    assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).

  16. Bleeding on Probing-BOP - 6m

    Time frame: after 6 months

    assessment of bleeding on probing Mühlemann Papillary Bleeding Index , a four-grade index based on both the extent of bleeding and the time it takes for bleeding to occur after stimulation with a periodontal probe (0-the best outcome, 4-the worst outcome).

  17. Plaque Index- PI

    Time frame: baseline measure (before the intervention)

    visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome

  18. Plaque Index- PI -1m

    Time frame: after 1 month

    visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome

  19. Plaque Index- PI -3m

    Time frame: after 3 months

    visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome

  20. Plaque Index- PI - 6m

    Time frame: after 6 months

    visual assessment of plaque index-PI and by probing

  21. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF)

    Time frame: baseline measure (before the intervention)

    Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) at baseline

  22. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m

    Time frame: after 1 month

    Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 1 month

  23. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m

    Time frame: after 3 months

    Number of periodontal pockets with presence/absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) after 3 months

  24. Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m

    Time frame: after 6 months

    Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 6 months

  25. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF)

    Time frame: baseline measure (before the intervention)

    Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) at baseline

  26. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m

    Time frame: after 1 month

    Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) after 1 month

  27. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m

    Time frame: after 3 months

    Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 3 months.

  28. Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m

    Time frame: after 6 months

    Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 6 months.

  29. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF)

    Time frame: baseline measure (before the intervention)

    Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) at baseline

  30. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m

    Time frame: after 1 month

    Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 1 month.

  31. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m

    Time frame: after 3 months

    Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 3 months.

  32. Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m

    Time frame: after 6 months

    Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 6 months.

  33. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF)

    Time frame: baseline measure (before the intervention)

    Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) at baseline

  34. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m

    Time frame: after 1 month

    Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 1 month.

  35. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m

    Time frame: after 3 months

    Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 3 months.

  36. Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m

    Time frame: after 6 months

    Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months.

  37. Periodontal Pocket Microorganisms

    Time frame: baseline measure (before the intervention)

    The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.

  38. Periodontal Pocket Microorganisms -1m

    Time frame: after 1 month

    The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month.

  39. Periodontal Pocket Microorganisms - 3m

    Time frame: after 3 months

    The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months.

  40. Periodontal Pocket Microorganisms - 6m

    Time frame: after 6 months

    The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months.

  41. Tumor Necrosis Factor Alpha-TNF-α

    Time frame: baseline measure (before the intervention)

    concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit

  42. Tumor Necrosis Factor Alpha-TNF-α -1m

    Time frame: after 1 month

    The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit

  43. Tumor Necrosis Factor Alpha-TNF-α - 3m

    Time frame: after 3 months

    The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months.

  44. Tumor Necrosis Factor Alpha-TNF-α -6m

    Time frame: after 6 months

    The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months.

  45. Matrix Metalloproteinase 8 - MMP-8

    Time frame: baseline measure (before the intervention)

    The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit

  46. Matrix Metalloproteinase 8 - MMP-8 -1m

    Time frame: after 1 month

    The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month.

  47. Matrix Metalloproteinase 8 - MMP-8 - 3m

    Time frame: after 3 months

    The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.

  48. Matrix Metalloproteinase 8 - MMP-8 - 6m

    Time frame: after 6 months

    The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.

  49. Alkaline Phosphatase - ALP

    Time frame: baseline measure (before the intervention)

    The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit

  50. Alkaline Phosphatase - ALP -1m

    Time frame: after 1 month

    The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.

  51. Alkaline Phosphatase - ALP -3m

    Time frame: after 3 months

    The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.

  52. Alkaline Phosphatase - ALP -6m

    Time frame: after 6 months

    The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis

Acronym: EIPRFITCP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2019
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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