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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Experimental | Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin |
|
| SRP + placebo | Placebo Comparator | Scaling and root planing in conjunction with saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP + Injectable Platelet-Rich Fibrin | Drug | Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing |
|
| 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 |
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Inclusion Criteria:
A minimum of 6 teeth per quadrant;
Exclusion Criteria:
Periodontal therapy within last 12 months;
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| Name | Affiliation | Role |
|---|---|---|
| Mila Vuckovic, Dr. | Assistant Lecturer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade | Belgrade | 11000 | Serbia |
Periodontitis patients with systemic and/or other oral disease or ongoing drug therapy are excluded.
October 2019 Department of Periodontology and Oral Medicine School of Dental Medicine University of Belgrade
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Study participants randomly assigned to receive two different treatments in cross - over study design: Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin and Scaling and root planing in conjunction with saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
32 participants
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Study participants randomly assigned to receive two different treatments in cross- over study design : scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin and Scaling and root planing in conjunction with saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | unit was periodontal pocket - one side of the jaw (left or right), not whole patient |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Periodontal Pocket Depth-PPD | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw | Posted | Mean | Standard Deviation | mm | baseline measure (before the intervention) | periodontal pocket | periodontal pocket |
|
Adverse events were not monitored/assessed.
Adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SRP + Injectable Platelet-Rich Fibrin | Scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin SRP + Injectable Platelet-Rich Fibrin: Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mila Vuckovic | Department of Periodontology and Oral Medicine, School of Dental Medicine, University of Belgrade | +381637060694 | jovanovic.dr.mila@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 26, 2020 | May 12, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2020 | May 12, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2020 | May 12, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C043309 | proliferation regulatory factors, human urine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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split mouth design
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|
| SRP + placebo | Drug | Saline application during scaling and root planing |
|
|
| 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 |
| periodontal pocket |
|
| Count of Participants |
| Participants |
| Participants |
|
|
| Sex: Female, Male | unit was periodontal pocket - one side of the jaw (left or right), not whole patient | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | unit was periodontal pocket - one side of the jaw (left or right), not whole patient | Number | participants | Participants |
|
|
| mean value of periodontal pockets on one side of the jaw | Mean | Standard Deviation | periodontal pocket | periodontal pocket |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| periodontal pocket |
|
|
|
| Primary | Periodontal Pocket Depth-PPD - 1m | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw | Posted | Mean | Standard Deviation | mm | after 1 month | periodontal pocket | periodontal pocket |
|
|
|
|
| Primary | Periodontal Pocket Depth-PPD - 3m | assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw | Posted | Mean | Standard Deviation | mm | after 3 months | periodontal pocket | periodontal pocket |
|
|
|
|
| Primary | Periodontal Pocket Depth-PPD - 6 | assessment of periodontal pocket depth by probing mean value of one side of the jaw | Posted | Mean | Standard Deviation | mm | after 6 months | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm | baseline measure (before the intervention) | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm | after 1 month | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm | after 3 months | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm | after 6 months | periodontal pocket | periodontal pocket |
|
|
|
|
| Primary | Clinical Attachment Level- CAL | assessment of clinical attachment level- CAL by probing | Posted | Mean | Standard Deviation | mm | baseline measure (before the intervention) | periodontal pocket | periodontal pocket |
|
|
|
|
| Primary | Clinical Attachment Level- CAL - 1m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | Posted | Mean | Standard Deviation | mm | after 1 month | periodontal pocket | periodontal pocket |
|
|
|
|
| Primary | Clinical Attachment Level- CAL - 3m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | Posted | Mean | Standard Deviation | mm | after 3 months | periodontal pocket | periodontal pocket |
|
|
|
|
| Primary | Clinical Attachment Level- CAL - 6m | assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw | Posted | Mean | Standard Deviation | mm | after 6 months | periodontal pocket | periodontal pocket |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | baseline measure (before the intervention) | periodontal pocket | periodontal pocket |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | after 1 month | periodontal pocket | periodontal pocket |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | after 3 months | periodontal pocket | periodontal pocket |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | after 6 months | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | baseline measure (before the intervention) | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | after 1 month | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | after 3 months | periodontal pocket | periodontal pocket |
|
|
|
|
| Primary | Plaque Index- PI - 6m | visual assessment of plaque index-PI and by probing | Posted | Mean | Standard Deviation | score on a scale | after 6 months | periodontal pocket | periodontal pocket |
|
|
|
|
| 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 | Posted | Count of Units | GCF- periodontal pocket | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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 | Posted | Count of Units | GCF- periodontal pocket | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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 | Posted | Count of Units | GCF- periodontal pocket | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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 | Posted | Count of Units | GCF- periodontal pocket | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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 | Posted | Count of Units | GCF- periodontal pocket | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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 | Posted | Count of Units | GCF- periodontal pocket | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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. | Posted | Count of Units | GCF- periodontal pocket | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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. | Posted | Count of Units | GCF- periodontal pocket | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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 | Posted | Count of Units | GCF- periodontal pocket | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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. | Posted | Count of Units | GCF- periodontal pocket | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
|
|
| 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. | Posted | Count of Units | GCF- periodontal pocket | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
|
|
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| 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. | Posted | Count of Units | GCF- periodontal pocket | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| 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 | Posted | Count of Units | GCF- periodontal pocket | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
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| 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. | Posted | Count of Units | GCF- periodontal pocket | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
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| 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. | Posted | Count of Units | GCF- periodontal pocket | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| 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. | Posted | Count of Units | GCF- periodontal pocket | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Periodontal Pocket Microorganisms | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time. | Posted | Mean | Standard Deviation | copy number | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Periodontal Pocket Microorganisms -1m | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month. | Posted | Mean | Standard Deviation | copy number | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Periodontal Pocket Microorganisms - 3m | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months. | Posted | Mean | Standard Deviation | copy number | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Periodontal Pocket Microorganisms - 6m | The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months. | Posted | Mean | Standard Deviation | copy number | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Tumor Necrosis Factor Alpha-TNF-α | concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit | Posted | Mean | Standard Deviation | pg/µl | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Tumor Necrosis Factor Alpha-TNF-α -1m | The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit | Posted | Mean | Standard Deviation | pg/µl | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Tumor Necrosis Factor Alpha-TNF-α - 3m | The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months. | Posted | Mean | Standard Deviation | pg/µl | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Tumor Necrosis Factor Alpha-TNF-α -6m | The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months. | Posted | Mean | Standard Deviation | pg/µl | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Matrix Metalloproteinase 8 - MMP-8 | The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit | Posted | Mean | Standard Deviation | pg/ml | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Matrix Metalloproteinase 8 - MMP-8 -1m | The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month. | Posted | Mean | Standard Deviation | pg/ml | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Matrix Metalloproteinase 8 - MMP-8 - 3m | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months. | Posted | Mean | Standard Deviation | pg/ml | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Matrix Metalloproteinase 8 - MMP-8 - 6m | The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months. | Posted | Mean | Standard Deviation | pg/ml | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Alkaline Phosphatase - ALP | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit | Posted | Mean | Standard Deviation | pg/ml | baseline measure (before the intervention) | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Alkaline Phosphatase - ALP -1m | The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month. | Posted | Mean | Standard Deviation | pg/ml | after 1 month | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Alkaline Phosphatase - ALP -3m | The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months. | Posted | Mean | Standard Deviation | pg/ml | after 3 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| Primary | Alkaline Phosphatase - ALP -6m | The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months. | Posted | Mean | Standard Deviation | pg/ml | after 6 months | GCF- periodontal pocket | GCF- periodontal pocket |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SRP + Placebo | Scaling and root planing in conjunction with saline SRP + placebo: Saline as adjunct to scaling and root planing | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D017670 |
| Sodium Compounds |