Periodontitis
Conditions
Keywords
periodontitis, therapy, Platelet, Rich, Fibrin, Nonsurgical
Brief 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.
Detailed description
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).
Interventions
Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing
DRUGSRP + placebo
Saline application during scaling and root planing
Sponsors
University of Belgrade
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
split mouth design
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Pocket Depth-PPD | baseline measure (before the intervention) | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw |
| Periodontal Pocket Depth-PPD - 1m | after 1 month | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw |
| Periodontal Pocket Depth-PPD - 3m | after 3 months | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw |
| Periodontal Pocket Depth-PPD - 6 | after 6 months | assessment of periodontal pocket depth by probing mean value of one side of the jaw |
| Level of Gingival Margin-LGM | 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 |
| Level of Gingival Margin-LGM - 1m | 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 |
| Level of Gingival Margin-LGM - 3m | 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 |
| Level of Gingival Margin-LGM - 6m | 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 |
| Clinical Attachment Level- CAL | baseline measure (before the intervention) | assessment of clinical attachment level- CAL by probing |
| Clinical Attachment Level- CAL - 1m | after 1 month | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw |
| Clinical Attachment Level- CAL - 3m | after 3 months | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw |
| Clinical Attachment Level- CAL - 6m | after 6 months | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw |
| Bleeding on Probing-BOP | 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). |
| Bleeding on Probing-BOP - 1m | 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). |
| Bleeding on Probing-BOP 3m | 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). |
| Bleeding on Probing-BOP - 6m | 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). |
| Plaque Index- PI | 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 |
| Plaque Index- PI -1m | 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 |
| Plaque Index- PI -3m | 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 |
| Plaque Index- PI - 6m | after 6 months | visual assessment of plaque index-PI and by probing |
| Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) | baseline measure (before the intervention) | Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) at baseline |
| Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m | after 1 month | Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 1 month |
| Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m | after 3 months | Number of periodontal pockets with presence/absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) after 3 months |
| Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m | after 6 months | Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 6 months |
| Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) | baseline measure (before the intervention) | Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) at baseline |
| Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m | after 1 month | Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) after 1 month |
| Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m | after 3 months | Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 3 months. |
| Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m | after 6 months | Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 6 months. |
| Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) | baseline measure (before the intervention) | Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) at baseline |
| Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m | after 1 month | Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 1 month. |
| Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m | after 3 months | Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 3 months. |
| Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m | after 6 months | Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 6 months. |
| Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) | baseline measure (before the intervention) | Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) at baseline |
| Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m | after 1 month | Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 1 month. |
| Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m | after 3 months | Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 3 months. |
| Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m | after 6 months | Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months. |
| Periodontal Pocket Microorganisms | baseline measure (before the intervention) | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time. |
| Periodontal Pocket Microorganisms -1m | after 1 month | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month. |
| Periodontal Pocket Microorganisms - 3m | after 3 months | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months. |
| Periodontal Pocket Microorganisms - 6m | after 6 months | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months. |
| Tumor Necrosis Factor Alpha-TNF-α | baseline measure (before the intervention) | concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit |
| Tumor Necrosis Factor Alpha-TNF-α -1m | after 1 month | The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit |
| Tumor Necrosis Factor Alpha-TNF-α - 3m | after 3 months | The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months. |
| Tumor Necrosis Factor Alpha-TNF-α -6m | after 6 months | The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months. |
| Matrix Metalloproteinase 8 - MMP-8 | baseline measure (before the intervention) | The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit |
| Matrix Metalloproteinase 8 - MMP-8 -1m | after 1 month | The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month. |
| Matrix Metalloproteinase 8 - MMP-8 - 3m | after 3 months | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months. |
| Matrix Metalloproteinase 8 - MMP-8 - 6m | after 6 months | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months. |
| Alkaline Phosphatase - ALP | baseline measure (before the intervention) | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit |
| Alkaline Phosphatase - ALP -1m | after 1 month | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month. |
| Alkaline Phosphatase - ALP -3m | after 3 months | The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months. |
| Alkaline Phosphatase - ALP -6m | after 6 months | The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months. |
Countries
Serbia
Participant flow
Recruitment details
October 2019 Department of Periodontology and Oral Medicine School of Dental Medicine University of Belgrade
Pre-assignment details
Periodontitis patients with systemic and/or other oral disease or ongoing drug therapy are excluded.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Study participants randomly assigned to receive two different treatments in cross- over study design : scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin and Scaling and root planing in conjunction with saline | 32 |
| All Study Participants Study participants randomly assigned to receive two different treatments in cross- over study design : scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin and Scaling and root planing in conjunction with saline | 64 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| mean value of periodontal pockets on one side of the jaw | 32 periodontal pocket STANDARD_DEVIATION 0 |
| Region of Enrollment Serbia | 32 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Alkaline Phosphatase - ALP
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Alkaline Phosphatase - ALP | 280.496 pg/ml | Standard Deviation 95.941 |
| SRP + Placebo | Alkaline Phosphatase - ALP | 280.852 pg/ml | Standard Deviation 96.263 |
p-value: 0.753Wilcoxon (Mann-Whitney)
Primary
Alkaline Phosphatase - ALP -1m
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Alkaline Phosphatase - ALP -1m | 116.936 pg/ml | Standard Deviation 37.529 |
| SRP + Placebo | Alkaline Phosphatase - ALP -1m | 199.666 pg/ml | Standard Deviation 76.413 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Alkaline Phosphatase - ALP -3m
The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Alkaline Phosphatase - ALP -3m | 145.716 pg/ml | Standard Deviation 49.959 |
| SRP + Placebo | Alkaline Phosphatase - ALP -3m | 216.835 pg/ml | Standard Deviation 79.486 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Alkaline Phosphatase - ALP -6m
The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Alkaline Phosphatase - ALP -6m | 237.554 pg/ml | Standard Deviation 79.872 |
| SRP + Placebo | Alkaline Phosphatase - ALP -6m | 268.905 pg/ml | Standard Deviation 90.331 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Bleeding on Probing-BOP
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).
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Bleeding on Probing-BOP | 1.418 score on a scale | Standard Deviation 0.714 |
| SRP + Placebo | Bleeding on Probing-BOP | 1.345 score on a scale | Standard Deviation 0.711 |
p-value: 0.063Wilcoxon (Mann-Whitney)
Primary
Bleeding on Probing-BOP - 1m
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).
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Bleeding on Probing-BOP - 1m | 0.649 score on a scale | Standard Deviation 0.454 |
| SRP + Placebo | Bleeding on Probing-BOP - 1m | 1.005 score on a scale | Standard Deviation 0.562 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Bleeding on Probing-BOP 3m
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).
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Bleeding on Probing-BOP 3m | 0.298 score on a scale | Standard Deviation 0.28 |
| SRP + Placebo | Bleeding on Probing-BOP 3m | 0.601 score on a scale | Standard Deviation 0.392 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Bleeding on Probing-BOP - 6m
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).
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Bleeding on Probing-BOP - 6m | 0.098 score on a scale | Standard Deviation 0.09 |
| SRP + Placebo | Bleeding on Probing-BOP - 6m | 0.257 score on a scale | Standard Deviation 0.167 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Clinical Attachment Level- CAL
assessment of clinical attachment level- CAL by probing
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Clinical Attachment Level- CAL | 2.009 mm | Standard Deviation 0.724 |
| SRP + Placebo | Clinical Attachment Level- CAL | 2.018 mm | Standard Deviation 0.715 |
p-value: 0.773Wilcoxon (Mann-Whitney)
Primary
Clinical Attachment Level- CAL - 1m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Clinical Attachment Level- CAL - 1m | 1.453 mm | Standard Deviation 0.643 |
| SRP + Placebo | Clinical Attachment Level- CAL - 1m | 1.755 mm | Standard Deviation 0.654 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Clinical Attachment Level- CAL - 3m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Clinical Attachment Level- CAL - 3m | 1.237 mm | Standard Deviation 0.61 |
| SRP + Placebo | Clinical Attachment Level- CAL - 3m | 1.619 mm | Standard Deviation 0.618 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Clinical Attachment Level- CAL - 6m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Clinical Attachment Level- CAL - 6m | 1.226 mm | Standard Deviation 0.58 |
| SRP + Placebo | Clinical Attachment Level- CAL - 6m | 1.585 mm | Standard Deviation 0.619 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Level of Gingival Margin-LGM
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
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Level of Gingival Margin-LGM | 1.737 mm | Standard Deviation 0.567 |
| SRP + Placebo | Level of Gingival Margin-LGM | 1.787 mm | Standard Deviation 0.589 |
p-value: 0.575Wilcoxon (Mann-Whitney)
Primary
Level of Gingival Margin-LGM - 1m
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
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Level of Gingival Margin-LGM - 1m | 0.948 mm | Standard Deviation 0.573 |
| SRP + Placebo | Level of Gingival Margin-LGM - 1m | 1.150 mm | Standard Deviation 0.462 |
p-value: 0.575Wilcoxon (Mann-Whitney)
Primary
Level of Gingival Margin-LGM - 3m
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
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Level of Gingival Margin-LGM - 3m | 0.782 mm | Standard Deviation 0.58 |
| SRP + Placebo | Level of Gingival Margin-LGM - 3m | 0.877 mm | Standard Deviation 0.533 |
p-value: 0.249Wilcoxon (Mann-Whitney)
Primary
Level of Gingival Margin-LGM - 6m
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
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Level of Gingival Margin-LGM - 6m | 0.808 mm | Standard Deviation 0.518 |
| SRP + Placebo | Level of Gingival Margin-LGM - 6m | 0.794 mm | Standard Deviation 0.457 |
p-value: 0.871Wilcoxon (Mann-Whitney)
Primary
Matrix Metalloproteinase 8 - MMP-8
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Matrix Metalloproteinase 8 - MMP-8 | 11.315 pg/ml | Standard Deviation 1.741 |
| SRP + Placebo | Matrix Metalloproteinase 8 - MMP-8 | 11.336 pg/ml | Standard Deviation 1.72 |
p-value: 0.671Wilcoxon (Mann-Whitney)
Primary
Matrix Metalloproteinase 8 - MMP-8 -1m
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month.
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Matrix Metalloproteinase 8 - MMP-8 -1m | 7.906 pg/ml | Standard Deviation 1.356 |
| SRP + Placebo | Matrix Metalloproteinase 8 - MMP-8 -1m | 9.964 pg/ml | Standard Deviation 1.488 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Matrix Metalloproteinase 8 - MMP-8 - 3m
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Matrix Metalloproteinase 8 - MMP-8 - 3m | 6.010 pg/ml | Standard Deviation 1.357 |
| SRP + Placebo | Matrix Metalloproteinase 8 - MMP-8 - 3m | 9.061 pg/ml | Standard Deviation 1.364 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Matrix Metalloproteinase 8 - MMP-8 - 6m
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Matrix Metalloproteinase 8 - MMP-8 - 6m | 4.681 pg/ml | Standard Deviation 1.465 |
| SRP + Placebo | Matrix Metalloproteinase 8 - MMP-8 - 6m | 8.642 pg/ml | Standard Deviation 1.303 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF)
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) at baseline
Time frame: baseline measure (before the intervention)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 24 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 6 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 24 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 6 GCF- periodontal pocket |
p-value: 0.999McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 1 month
Time frame: after 1 month
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m | Presence of microorganism | 5 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m | Absence of mimcroorganism | 25 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m | Presence of microorganism | 18 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m | Absence of mimcroorganism | 12 GCF- periodontal pocket |
p-value: 0McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m
Number of periodontal pockets with presence/absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) after 3 months
Time frame: after 3 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 8 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 22 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 16 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 14 GCF- periodontal pocket |
p-value: 0.008McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 6 months
Time frame: after 6 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m | Presence of microorganism | 17 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m | Absence of mimcroorganism | 13 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m | Presence of microorganism | 19 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m | Absence of mimcroorganism | 11 GCF- periodontal pocket |
p-value: 0.5McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF)
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) at baseline
Time frame: baseline measure (before the intervention)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 30 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 0 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 30 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 0 GCF- periodontal pocket |
p-value: 0.999McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) after 1 month
Time frame: after 1 month
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m | Presence of microorganism | 12 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m | Absence of mimcroorganism | 18 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m | Presence of microorganism | 28 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m | Absence of mimcroorganism | 2 GCF- periodontal pocket |
p-value: 0McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 3 months.
Time frame: after 3 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 21 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 9 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 27 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 3 GCF- periodontal pocket |
p-value: 0.4McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 6 months.
Time frame: after 6 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m | Presence of microorganism | 28 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m | Absence of mimcroorganism | 2 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m | Presence of microorganism | 29 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m | Absence of mimcroorganism | 1 GCF- periodontal pocket |
p-value: 0.999McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF)
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) at baseline
Time frame: baseline measure (before the intervention)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 27 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 3 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 27 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 3 GCF- periodontal pocket |
p-value: 0.999McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 1 month.
Time frame: after 1 month
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m | Presence of microorganism | 12 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m | Absence of mimcroorganism | 18 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m | Presence of microorganism | 23 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m | Absence of mimcroorganism | 7 GCF- periodontal pocket |
p-value: 0.001McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 3 months.
Time frame: after 3 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 17 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 13 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 20 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 10 GCF- periodontal pocket |
p-value: 0.453McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 6 months.
Time frame: after 6 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m | Presence of microorganism | 22 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m | Absence of mimcroorganism | 8 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m | Presence of microorganism | 24 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m | Absence of mimcroorganism | 6 GCF- periodontal pocket |
p-value: 0.625McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF)
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) at baseline
Time frame: baseline measure (before the intervention)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 24 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 6 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) | Presence of microorganism | 24 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) | Absence of mimcroorganism | 6 GCF- periodontal pocket |
p-value: 0.999McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 1 month.
Time frame: after 1 month
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m | Presence of microorganism | 7 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m | Absence of mimcroorganism | 23 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m | Presence of microorganism | 23 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m | Absence of mimcroorganism | 7 GCF- periodontal pocket |
p-value: 0McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 3 months.
Time frame: after 3 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 11 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 19 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m | Presence of microorganism | 24 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m | Absence of mimcroorganism | 6 GCF- periodontal pocket |
p-value: 0.001McNemar
Primary
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months.
Time frame: after 6 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m | Presence of microorganism | 17 GCF- periodontal pocket |
| SRP + Injectable Platelet-Rich Fibrin | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m | Absence of mimcroorganism | 13 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m | Presence of microorganism | 24 GCF- periodontal pocket |
| SRP + Placebo | Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m | Absence of mimcroorganism | 6 GCF- periodontal pocket |
p-value: 0.065McNemar
Primary
Periodontal Pocket Depth-PPD
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Depth-PPD | 3.735 mm | Standard Deviation 0.863 |
| SRP + Placebo | Periodontal Pocket Depth-PPD | 3.696 mm | Standard Deviation 0.851 |
p-value: 0.429Wilcoxon (Mann-Whitney)
Primary
Periodontal Pocket Depth-PPD - 1m
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Depth-PPD - 1m | 2.398 mm | Standard Deviation 0.792 |
| SRP + Placebo | Periodontal Pocket Depth-PPD - 1m | 2.876 mm | Standard Deviation 0.804 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Periodontal Pocket Depth-PPD - 3m
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Depth-PPD - 3m | 1.990 mm | Standard Deviation 0.64 |
| SRP + Placebo | Periodontal Pocket Depth-PPD - 3m | 2.567 mm | Standard Deviation 0.701 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Periodontal Pocket Depth-PPD - 6
assessment of periodontal pocket depth by probing mean value of one side of the jaw
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Depth-PPD - 6 | 1.778 mm | Standard Deviation 0.542 |
| SRP + Placebo | Periodontal Pocket Depth-PPD - 6 | 2.409 mm | Standard Deviation 0.64 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Periodontal Pocket Microorganisms
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Microorganisms | 2408369.00 copy number | Standard Deviation 3488796.726 |
| SRP + Placebo | Periodontal Pocket Microorganisms | 2372881.00 copy number | Standard Deviation 3483340.472 |
p-value: 0.821Wilcoxon (Mann-Whitney)
Primary
Periodontal Pocket Microorganisms -1m
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month.
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Microorganisms -1m | 27708.86 copy number | Standard Deviation 60036.838 |
| SRP + Placebo | Periodontal Pocket Microorganisms -1m | 323142 copy number | Standard Deviation 458640 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Periodontal Pocket Microorganisms - 3m
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months.
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Microorganisms - 3m | 825098.93 copy number | Standard Deviation 4246296.647 |
| SRP + Placebo | Periodontal Pocket Microorganisms - 3m | 226048.10 copy number | Standard Deviation 680604 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Primary
Periodontal Pocket Microorganisms - 6m
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months.
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Periodontal Pocket Microorganisms - 6m | 71493.73 copy number | Standard Deviation 95627.954 |
| SRP + Placebo | Periodontal Pocket Microorganisms - 6m | 336812.27 copy number | Standard Deviation 1057691 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Plaque Index- PI
visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Plaque Index- PI | 1.231 score on a scale | Standard Deviation 0.559 |
| SRP + Placebo | Plaque Index- PI | 1.241 score on a scale | Standard Deviation 0.565 |
p-value: 0.085Wilcoxon (Mann-Whitney)
Primary
Plaque Index- PI -1m
visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Plaque Index- PI -1m | 0.255 score on a scale | Standard Deviation 0.202 |
| SRP + Placebo | Plaque Index- PI -1m | 0.250 score on a scale | Standard Deviation 0.185 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Plaque Index- PI -3m
visual assessment of plaque index-PI and by probing Plaque Index (Silness and Löe), 0-the best outcome, 3-the worst outcome
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Plaque Index- PI -3m | 0.236 score on a scale | Standard Deviation 0.254 |
| SRP + Placebo | Plaque Index- PI -3m | 0.212 score on a scale | Standard Deviation 0.182 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Plaque Index- PI - 6m
visual assessment of plaque index-PI and by probing
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Plaque Index- PI - 6m | 0.199 score on a scale | Standard Deviation 0.185 |
| SRP + Placebo | Plaque Index- PI - 6m | 0.203 score on a scale | Standard Deviation 0.184 |
p-value: 0.895Wilcoxon (Mann-Whitney)
Primary
Tumor Necrosis Factor Alpha-TNF-α
concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Time frame: baseline measure (before the intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Tumor Necrosis Factor Alpha-TNF-α | 0.925 pg/µl | Standard Deviation 0.109 |
| SRP + Placebo | Tumor Necrosis Factor Alpha-TNF-α | 0.918 pg/µl | Standard Deviation 0.105 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Tumor Necrosis Factor Alpha-TNF-α -1m
The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Time frame: after 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Tumor Necrosis Factor Alpha-TNF-α -1m | 0.382 pg/µl | Standard Deviation 0.04 |
| SRP + Placebo | Tumor Necrosis Factor Alpha-TNF-α -1m | 0.782 pg/µl | Standard Deviation 0.092 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Tumor Necrosis Factor Alpha-TNF-α - 3m
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months.
Time frame: after 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Tumor Necrosis Factor Alpha-TNF-α - 3m | 0.259 pg/µl | Standard Deviation 0.04 |
| SRP + Placebo | Tumor Necrosis Factor Alpha-TNF-α - 3m | 0.587 pg/µl | Standard Deviation 0.104 |
p-value: 0Wilcoxon (Mann-Whitney)
Primary
Tumor Necrosis Factor Alpha-TNF-α -6m
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months.
Time frame: after 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Tumor Necrosis Factor Alpha-TNF-α -6m | 0.238 pg/µl | Standard Deviation 0.034 |
| SRP + Placebo | Tumor Necrosis Factor Alpha-TNF-α -6m | 0.456 pg/µl | Standard Deviation 0.072 |
p-value: 0Wilcoxon (Mann-Whitney)