Phase 4
N=32
Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT04178590 ↗Enrolled (actual)
32
Serious AEs
—
Results posted
Jun 2020
Primary outcome: Primary: Periodontal Pocket Depth-PPD — 3.735; 3.696 mm — p=0.429
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SRP + Injectable Platelet-Rich Fibrin (Drug); SRP + placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Belgrade
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Periodontal Pocket Depth-PPD |
3.735; 3.696 | 0.429 |
| PRIMARY Periodontal Pocket Depth-PPD - 1m |
2.398; 2.876 | 0.000 sig |
| PRIMARY Periodontal Pocket Depth-PPD - 3m |
1.990; 2.567 | 0.000 sig |
| PRIMARY Periodontal Pocket Depth-PPD - 6 |
1.778; 2.409 | 0.000 sig |
| PRIMARY Level of Gingival Margin-LGM |
1.737; 1.787 | 0.575 |
| PRIMARY Level of Gingival Margin-LGM - 1m |
0.948; 1.150 | 0.575 |
| PRIMARY Level of Gingival Margin-LGM - 3m |
0.782; 0.877 | 0.249 |
| PRIMARY Level of Gingival Margin-LGM - 6m |
0.808; 0.794 | 0.871 |
| PRIMARY Clinical Attachment Level- CAL |
2.009; 2.018 | 0.773 |
| PRIMARY Clinical Attachment Level- CAL - 1m |
1.453; 1.755 | 0.000 sig |
| PRIMARY Clinical Attachment Level- CAL - 3m |
1.237; 1.619 | 0.000 sig |
| PRIMARY Clinical Attachment Level- CAL - 6m |
1.226; 1.585 | 0.000 sig |
| PRIMARY Bleeding on Probing-BOP |
1.418; 1.345 | 0.063 |
| PRIMARY Bleeding on Probing-BOP - 1m |
0.649; 1.005 | 0.000 sig |
| PRIMARY Bleeding on Probing-BOP 3m |
0.298; 0.601 | 0.000 sig |
| PRIMARY Bleeding on Probing-BOP - 6m |
0.098; 0.257 | 0.000 sig |
| PRIMARY Plaque Index- PI |
1.231; 1.241 | 0.085 |
| PRIMARY Plaque Index- PI -1m |
0.255; 0.250 | 0.000 sig |
| PRIMARY Plaque Index- PI -3m |
0.236; 0.212 | 0.000 sig |
| PRIMARY Plaque Index- PI - 6m |
0.199; 0.203 | 0.895 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) |
24; 24; 6; 6 | 0.999 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m |
5; 18; 25; 12 | 0.000 sig |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m |
8; 16; 22; 14 | 0.008 sig |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m |
17; 19; 13; 11 | 0.500 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) |
30; 30; 0; 0 | 0.999 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m |
12; 28; 18; 2 | 0.000 sig |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m |
21; 27; 9; 3 | 0.40 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m |
28; 29; 2; 1 | 0.999 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) |
27; 27; 3; 3 | 0.999 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m |
12; 23; 18; 7 | 0.001 sig |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m |
17; 20; 13; 10 | 0.453 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m |
22; 24; 8; 6 | 0.625 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) |
24; 24; 6; 6 | 0.999 |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m |
7; 23; 23; 7 | 0.000 sig |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m |
11; 24; 19; 6 | 0.001 sig |
| PRIMARY Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m |
17; 24; 13; 6 | 0.065 |
| PRIMARY Periodontal Pocket Microorganisms |
2408369.00; 2372881.00 | 0.821 |
| PRIMARY Periodontal Pocket Microorganisms -1m |
27708.86; 323142 | 0.000 sig |
| PRIMARY Periodontal Pocket Microorganisms - 3m |
825098.93; 226048.10 | 0.001 sig |
| PRIMARY Periodontal Pocket Microorganisms - 6m |
71493.73; 336812.27 | 0.000 sig |
| PRIMARY Tumor Necrosis Factor Alpha-TNF-α |
0.925; 0.918 | 0.000 sig |
| PRIMARY Tumor Necrosis Factor Alpha-TNF-α -1m |
0.382; 0.782 | 0.000 sig |
| PRIMARY Tumor Necrosis Factor Alpha-TNF-α - 3m |
0.259; 0.587 | 0.000 sig |
| PRIMARY Tumor Necrosis Factor Alpha-TNF-α -6m |
0.238; 0.456 | 0.000 sig |
| PRIMARY Matrix Metalloproteinase 8 - MMP-8 |
11.315; 11.336 | 0.671 |
| PRIMARY Matrix Metalloproteinase 8 - MMP-8 -1m |
7.906; 9.964 | 0.000 sig |
| PRIMARY Matrix Metalloproteinase 8 - MMP-8 - 3m |
6.010; 9.061 | 0.000 sig |
| PRIMARY Matrix Metalloproteinase 8 - MMP-8 - 6m |
4.681; 8.642 | 0.000 sig |
| PRIMARY Alkaline Phosphatase - ALP |
280.496; 280.852 | 0.753 |
| PRIMARY Alkaline Phosphatase - ALP -1m |
116.936; 199.666 | 0.000 sig |
| PRIMARY Alkaline Phosphatase - ALP -3m |
145.716; 216.835 | 0.000 sig |
| PRIMARY Alkaline Phosphatase - ALP -6m |
237.554; 268.905 | 0.000 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04178590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.