PeriodontitisPhase 4EIPRFITCPNCT04178590
Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
A Phase 4 study testing SRP + Injectable Platelet-Rich Fibrin in people with Periodontitis, run by University of Belgrade at 1 site in Serbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- SRP + Injectable Platelet-Rich Fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSerbia
- Study dates
- 2 Oct 2019to 9 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Belgrade, 11000
About this study
Official title: Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis
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.
Read the 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).
- Conditions
- Periodontitis
- Being tested
- SRP + Injectable Platelet-Rich Fibrin, SRP + placebo
- Keywords
- periodontitis, therapy, Platelet, Rich, Fibrin, Nonsurgical
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP + Injectable Platelet-Rich FibrinDrug
Also called SRP + i-PRF
Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing
SRP + placeboDrug
Also called SRP + saline
Saline application during scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Experimental | Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin Receives: Drug: SRP + Injectable Platelet-Rich Fibrin |
| SRP + placebo | Placebo comparator | Scaling and root planing in conjunction with saline Receives: Drug: SRP + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Pocket Depth-PPD
assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw
Measured: 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
Measured: 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
Measured: after 3 months
Periodontal Pocket Depth-PPD - 6
assessment of periodontal pocket depth by probing mean value of one side of the jaw
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after 6 months
Clinical Attachment Level- CAL
assessment of clinical attachment level- CAL by probing
Measured: 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
Measured: after 1 month
Clinical Attachment Level- CAL - 3m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Measured: after 3 months
Clinical Attachment Level- CAL - 6m
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: after 3 months
Plaque Index- PI - 6m
visual assessment of plaque index-PI and by probing
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after 6 months
Periodontal Pocket Microorganisms
The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after 6 months
Tumor Necrosis Factor Alpha-TNF-α
concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Measured: 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
Measured: 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.
Measured: 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.
Measured: after 6 months
Matrix Metalloproteinase 8 - MMP-8
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit
Measured: 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.
Measured: after 1 month
Matrix Metalloproteinase 8 - MMP-8 - 3m
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.
Measured: after 3 months
Matrix Metalloproteinase 8 - MMP-8 - 6m
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.
Measured: after 6 months
Alkaline Phosphatase - ALP
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit
Measured: baseline measure (before the intervention)
Alkaline Phosphatase - ALP -1m
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.
Measured: after 1 month
Alkaline Phosphatase - ALP -3m
The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.
Measured: after 3 months
Alkaline Phosphatase - ALP -6m
The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start2 Oct 2019
- Primary completion29 Jun 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- split mouth design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasa Nikolic Jakoba, University of Belgrade
- Investigators
- Mila Vuckovic, Dr., Principal investigator, Assistant Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178590
- Sponsor's protocol ID
- UBelgrade 783/2
- Acronym
- EIPRFITCP
- Status last verified
- Jul 2020
- First submitted
- 21 Nov 2019
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT04178590
- Acronym / sponsor ID
- EIPRFITCP / UBelgrade 783/2
- Conditions
- Periodontitis
- Keywords
- periodontitis, therapy, Platelet, Rich, Fibrin, Nonsurgical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- split mouth design
| Arm | Type | Receives |
|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Experimental | Drug: SRP + Injectable Platelet-Rich FibrinScaling and root planing in conjunction with Injectable Platelet-Rich Fibrin |
| SRP + placebo | Placebo comparator | Drug: SRP + placeboScaling and root planing in conjunction with saline |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A minimum of 6 teeth per quadrant;
Key exclusion criteria (6 listed)
- Periodontal therapy within last 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRP + Injectable Platelet-Rich FibrinAlso: SRP + i-PRFInjectable Platelet-Rich Fibrin application as adjunct to scaling and root planing | Drug | SRP + Injectable Platelet-Rich Fibrin |
| SRP + placeboAlso: SRP + salineSaline application during scaling and root planing | Drug | SRP + placebo |
Primary outcome
Periodontal Pocket Depth-PPD
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after 6 months
assessment of periodontal pocket depth by probing mean value of one side of the jaw
Level of Gingival Margin-LGM
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline measure (before the intervention)
assessment of clinical attachment level- CAL by probing
Clinical Attachment Level- CAL - 1m
Time frame: after 1 month
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Clinical Attachment Level- CAL - 3m
Time frame: after 3 months
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Clinical Attachment Level- CAL - 6m
Time frame: after 6 months
assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw
Bleeding on Probing-BOP
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after 1 month
The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit
Tumor Necrosis Factor Alpha-TNF-α - 3m
Time frame: 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
Time frame: after 6 months
The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months.
Matrix Metalloproteinase 8 - MMP-8
Time frame: baseline measure (before the intervention)
The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit
Matrix Metalloproteinase 8 - MMP-8 -1m
Time frame: 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
Time frame: after 3 months
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.
Matrix Metalloproteinase 8 - MMP-8 - 6m
Time frame: after 6 months
The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.
Alkaline Phosphatase - ALP
Time frame: baseline measure (before the intervention)
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit
Alkaline Phosphatase - ALP -1m
Time frame: after 1 month
The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.
Alkaline Phosphatase - ALP -3m
Time frame: after 3 months
The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.
Alkaline Phosphatase - ALP -6m
Time frame: after 6 months
The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mila Vuckovic, Dr. principal investigator
Assistant Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SRP + Injectable Platelet-Rich Fibrin in people with Periodontitis, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Pocket Depth-PPD (time frame: baseline measure (before the intervention)). The study lists 52 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.