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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: SRP + Injectable Platelet-Rich Fibrin
* Drug: SRP + placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: split mouth design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRP + Injectable Platelet-Rich Fibrin<br>Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin | Drug: SRP + Injectable Platelet-Rich Fibrin<br>* Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing<br>* Other names: SRP + i-PRF;|
| Placebo Comparator: SRP + placebo<br>Scaling and root planing in conjunction with saline | Drug: SRP + placebo<br>* Saline application during scaling and root planing<br>* Other names: SRP + saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal Pocket Depth-PPD | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw | baseline measure (before the intervention) | 
| Periodontal Pocket Depth-PPD - 1m | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw | after 1 month | 
| Periodontal Pocket Depth-PPD - 3m | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw | after 3 months | 
| Periodontal Pocket Depth-PPD - 6 | assessment of periodontal pocket depth by probing mean value of one side of the jaw | after 6 months | 
| 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 | baseline measure (before the intervention) | 
| 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 | after 1 month | 
| 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 | after 3 months | 
| 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 | after 6 months | 
| Clinical Attachment Level- CAL | assessment of clinical attachment level- CAL by probing | baseline measure (before the intervention) | 
| Clinical Attachment Level- CAL - 1m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | after 1 month | 
| Clinical Attachment Level- CAL - 3m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | after 3 months | 
| Clinical Attachment Level- CAL - 6m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | after 6 months | 
| 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). | baseline measure (before the intervention) | 
| 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). | after 1 month | 
| 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). | after 3 months | 
| 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). | after 6 months | 
| 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 | baseline measure (before the intervention) | 
| 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 | after 1 month | 
| 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 | after 3 months | 
| Plaque Index- PI - 6m | visual assessment of plaque index-PI and by probing | after 6 months | 
| 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 | baseline measure (before the intervention) | 
| 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 | after 1 month | 
| 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 | after 3 months | 
| 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 | after 6 months | 
| 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 | baseline measure (before the intervention) | 
| 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 | after 1 month | 
| 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. | after 3 months | 
| 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. | after 6 months | 
| 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 | baseline measure (before the intervention) | 
| 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. | after 1 month | 
| 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. | after 3 months | 
| 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. | after 6 months | 
| 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 | baseline measure (before the intervention) | 
| 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. | after 1 month | 
| 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. | after 3 months | 
| 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. | after 6 months | 
| Periodontal Pocket Microorganisms | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time. | baseline measure (before the intervention) | 
| Periodontal Pocket Microorganisms -1m | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month. | after 1 month | 
| Periodontal Pocket Microorganisms - 3m | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months. | after 3 months | 
| Periodontal Pocket Microorganisms - 6m | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months. | after 6 months | 
| Tumor Necrosis Factor Alpha-TNF-α | concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit | baseline measure (before the intervention) | 
| Tumor Necrosis Factor Alpha-TNF-α -1m | The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit | after 1 month | 
| Tumor Necrosis Factor Alpha-TNF-α - 3m | The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months. | after 3 months | 
| Tumor Necrosis Factor Alpha-TNF-α -6m | The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months. | after 6 months | 
| Matrix Metalloproteinase 8 - MMP-8 | The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit | baseline measure (before the intervention) | 
| Matrix Metalloproteinase 8 - MMP-8 -1m | The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month. | after 1 month | 
| Matrix Metalloproteinase 8 - MMP-8 - 3m | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months. | after 3 months | 
| Matrix Metalloproteinase 8 - MMP-8 - 6m | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months. | after 6 months | 
| Alkaline Phosphatase - ALP | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit | baseline measure (before the intervention) | 
| Alkaline Phosphatase - ALP -1m | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month. | after 1 month | 
| Alkaline Phosphatase - ALP -3m | The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months. | after 3 months | 
| Alkaline Phosphatase - ALP -6m | The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months. | after 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, therapy, Platelet, Rich, Fibrin, Nonsurgical