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

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Serbia
Study Type
Interventional
Intervention
SRP + Injectable Platelet-Rich Fibrin
SRP + placebo
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, therapy, Platelet, Rich, Fibrin, Nonsurgical

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SRP + Injectable Platelet-Rich Fibrin

SRP + placebo

Arm Description

Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin

Scaling and root planing in conjunction with saline

Outcomes

Primary Outcome Measures

Periodontal Pocket Depth-PPD
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Periodontal Pocket Depth-PPD - 1m
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Periodontal Pocket Depth-PPD - 3m
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Periodontal Pocket Depth-PPD - 6
assessment of periodontal pocket depth by probing mean value of one side of the jaw
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
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
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
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
Clinical Attachment Level- CAL
assessment of clinical attachment level- CAL by probing
Clinical Attachment Level- CAL - 1m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Clinical Attachment Level- CAL - 3m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Clinical Attachment Level- CAL - 6m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
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).
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).
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).
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).
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
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
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
Plaque Index- PI - 6m
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months.
Periodontal Pocket Microorganisms
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.
Periodontal Pocket Microorganisms -1m
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time 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.
Periodontal Pocket Microorganisms - 6m
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
concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Tumor Necrosis Factor Alpha-TNF-α -1m
The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Tumor Necrosis Factor Alpha-TNF-α - 3m
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit 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.
Matrix Metalloproteinase 8 - MMP-8
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit
Matrix Metalloproteinase 8 - MMP-8 -1m
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month.
Matrix Metalloproteinase 8 - MMP-8 - 3m
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.
Matrix Metalloproteinase 8 - MMP-8 - 6m
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.
Alkaline Phosphatase - ALP
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit
Alkaline Phosphatase - ALP -1m
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.
Alkaline Phosphatase - ALP -3m
The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.
Alkaline Phosphatase - ALP -6m
The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2019
Last Updated
July 9, 2020
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT04178590
Brief Title
Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
Acronym
EIPRFITCP
Official Title
Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
July 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
periodontitis, therapy, Platelet, Rich, Fibrin, Nonsurgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
split mouth design
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRP + Injectable Platelet-Rich Fibrin
Arm Type
Experimental
Arm Description
Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin
Arm Title
SRP + placebo
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing in conjunction with saline
Intervention Type
Drug
Intervention Name(s)
SRP + Injectable Platelet-Rich Fibrin
Other Intervention Name(s)
SRP + i-PRF
Intervention Description
Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing
Intervention Type
Drug
Intervention Name(s)
SRP + placebo
Other Intervention Name(s)
SRP + saline
Intervention Description
Saline application during scaling and root planing
Primary Outcome Measure Information:
Title
Periodontal Pocket Depth-PPD
Description
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)
Title
Periodontal Pocket Depth-PPD - 1m
Description
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Time Frame
after 1 month
Title
Periodontal Pocket Depth-PPD - 3m
Description
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Time Frame
after 3 months
Title
Periodontal Pocket Depth-PPD - 6
Description
assessment of periodontal pocket depth by probing mean value of one side of the jaw
Time Frame
after 6 months
Title
Level of Gingival Margin-LGM
Description
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)
Title
Level of Gingival Margin-LGM - 1m
Description
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
Title
Level of Gingival Margin-LGM - 3m
Description
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
Title
Level of Gingival Margin-LGM - 6m
Description
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
Title
Clinical Attachment Level- CAL
Description
assessment of clinical attachment level- CAL by probing
Time Frame
baseline measure (before the intervention)
Title
Clinical Attachment Level- CAL - 1m
Description
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Time Frame
after 1 month
Title
Clinical Attachment Level- CAL - 3m
Description
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Time Frame
after 3 months
Title
Clinical Attachment Level- CAL - 6m
Description
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Time Frame
after 6 months
Title
Bleeding on Probing-BOP
Description
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)
Title
Bleeding on Probing-BOP - 1m
Description
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
Title
Bleeding on Probing-BOP 3m
Description
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
Title
Bleeding on Probing-BOP - 6m
Description
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
Title
Plaque Index- PI
Description
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)
Title
Plaque Index- PI -1m
Description
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
Title
Plaque Index- PI -3m
Description
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
Title
Plaque Index- PI - 6m
Description
visual assessment of plaque index-PI and by probing
Time Frame
after 6 months
Title
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF)
Description
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) at baseline
Time Frame
baseline measure (before the intervention)
Title
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m
Description
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 1 month
Time Frame
after 1 month
Title
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m
Description
Number of periodontal pockets with presence/absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) after 3 months
Time Frame
after 3 months
Title
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m
Description
Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 6 months
Time Frame
after 6 months
Title
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF)
Description
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)
Title
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m
Description
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) after 1 month
Time Frame
after 1 month
Title
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m
Description
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 3 months.
Time Frame
after 3 months
Title
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m
Description
Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 6 months.
Time Frame
after 6 months
Title
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF)
Description
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)
Title
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m
Description
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 1 month.
Time Frame
after 1 month
Title
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m
Description
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 3 months.
Time Frame
after 3 months
Title
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m
Description
Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 6 months.
Time Frame
after 6 months
Title
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF)
Description
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)
Title
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m
Description
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 1 month.
Time Frame
after 1 month
Title
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m
Description
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 3 months.
Time Frame
after 3 months
Title
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m
Description
Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months.
Time Frame
after 6 months
Title
Periodontal Pocket Microorganisms
Description
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.
Time Frame
baseline measure (before the intervention)
Title
Periodontal Pocket Microorganisms -1m
Description
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month.
Time Frame
after 1 month
Title
Periodontal Pocket Microorganisms - 3m
Description
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months.
Time Frame
after 3 months
Title
Periodontal Pocket Microorganisms - 6m
Description
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months.
Time Frame
after 6 months
Title
Tumor Necrosis Factor Alpha-TNF-α
Description
concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Time Frame
baseline measure (before the intervention)
Title
Tumor Necrosis Factor Alpha-TNF-α -1m
Description
The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Time Frame
after 1 month
Title
Tumor Necrosis Factor Alpha-TNF-α - 3m
Description
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months.
Time Frame
after 3 months
Title
Tumor Necrosis Factor Alpha-TNF-α -6m
Description
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months.
Time Frame
after 6 months
Title
Matrix Metalloproteinase 8 - MMP-8
Description
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit
Time Frame
baseline measure (before the intervention)
Title
Matrix Metalloproteinase 8 - MMP-8 -1m
Description
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month.
Time Frame
after 1 month
Title
Matrix Metalloproteinase 8 - MMP-8 - 3m
Description
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.
Time Frame
after 3 months
Title
Matrix Metalloproteinase 8 - MMP-8 - 6m
Description
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.
Time Frame
after 6 months
Title
Alkaline Phosphatase - ALP
Description
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit
Time Frame
baseline measure (before the intervention)
Title
Alkaline Phosphatase - ALP -1m
Description
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.
Time Frame
after 1 month
Title
Alkaline Phosphatase - ALP -3m
Description
The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.
Time Frame
after 3 months
Title
Alkaline Phosphatase - ALP -6m
Description
The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.
Time Frame
after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mila Vuckovic, Dr.
Organizational Affiliation
Assistant Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

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

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