Periodontitis Clinical Trial
— EIPRFITCPOfficial title:
Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis
Verified date | July 2020 |
Source | University of Belgrade |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 9, 2020 |
Est. primary completion date | June 29, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Serbia | Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade |
Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | Periodontal Pocket Depth-PPD - 6 | assessment of periodontal pocket depth by probing mean value of one side of the jaw | after 6 months | |
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 | baseline measure (before the intervention) | |
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 | after 1 month | |
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 | after 3 months | |
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 | after 6 months | |
Primary | Clinical Attachment Level- CAL | assessment of clinical attachment level- CAL by probing | baseline measure (before the intervention) | |
Primary | Clinical Attachment Level- CAL - 1m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | after 1 month | |
Primary | Clinical Attachment Level- CAL - 3m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | after 3 months | |
Primary | Clinical Attachment Level- CAL - 6m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | after 6 months | |
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). | baseline measure (before the intervention) | |
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). | after 1 month | |
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). | after 3 months | |
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). | after 6 months | |
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 | baseline measure (before the intervention) | |
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 | after 1 month | |
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 | after 3 months | |
Primary | Plaque Index- PI - 6m | visual assessment of plaque index-PI and by probing | after 6 months | |
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 | baseline measure (before the intervention) | |
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 | after 1 month | |
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 | after 3 months | |
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 | after 6 months | |
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 | baseline measure (before the intervention) | |
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 | after 1 month | |
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. | after 3 months | |
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. | after 6 months | |
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 | baseline measure (before the intervention) | |
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. | after 1 month | |
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. | after 3 months | |
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. | after 6 months | |
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 | baseline measure (before the intervention) | |
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. | after 1 month | |
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. | after 3 months | |
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. | after 6 months | |
Primary | Periodontal Pocket Microorganisms | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time. | baseline measure (before the intervention) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Tumor Necrosis Factor Alpha-TNF-a | concentration of Tumor necrosis factor alpha-TNF-a in GCF using ELISA Kit | baseline measure (before the intervention) | |
Primary | Tumor Necrosis Factor Alpha-TNF-a -1m | The concentration of Tumor necrosis factor alpha-TNF-a in GCF using ELISA Kit | after 1 month | |
Primary | Tumor Necrosis Factor Alpha-TNF-a - 3m | The concentration of Tumor necrosis factor alpha-TNF-a using ELISA Kit after 3 months. | after 3 months | |
Primary | Tumor Necrosis Factor Alpha-TNF-a -6m | The concentration of Tumor necrosis factor alpha-TNF-a using ELISA Kit after 6 months. | after 6 months | |
Primary | Matrix Metalloproteinase 8 - MMP-8 | The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit | baseline measure (before the intervention) | |
Primary | 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 | |
Primary | Matrix Metalloproteinase 8 - MMP-8 - 3m | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months. | after 3 months | |
Primary | Matrix Metalloproteinase 8 - MMP-8 - 6m | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months. | after 6 months | |
Primary | Alkaline Phosphatase - ALP | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit | baseline measure (before the intervention) | |
Primary | Alkaline Phosphatase - ALP -1m | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month. | after 1 month | |
Primary | Alkaline Phosphatase - ALP -3m | The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months. | after 3 months | |
Primary | Alkaline Phosphatase - ALP -6m | The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months. | after 6 months |
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