Trial Outcomes & Findings for Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis (NCT NCT04178590)

NCT ID: NCT04178590

Last Updated: 2020-07-13

Results Overview

assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: baseline measure (before the intervention)
• Results posted on: 2020-07-13

Participant Flow

October 2019 Department of Periodontology and Oral Medicine School of Dental Medicine University of Belgrade

Periodontitis patients with systemic and/or other oral disease or ongoing drug therapy are excluded.

Unit of analysis: periodontal pockets

Participant milestones

Measure	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
Overall Study STARTED	32 64
Overall Study COMPLETED	30 60
Overall Study NOT COMPLETED	2 4

Reasons for withdrawal

Measure	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
Overall Study Pregnancy	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

unit was periodontal pocket - one side of the jaw (left or right), not whole patient

Baseline characteristics by cohort

Measure	All Study Participants n=64 periodontal pocket 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
Age, Categorical <=18 years	0 Participants n=32 Participants • unit was periodontal pocket - one side of the jaw (left or right), not whole patient
Age, Categorical Between 18 and 65 years	32 Participants n=32 Participants • unit was periodontal pocket - one side of the jaw (left or right), not whole patient
Age, Categorical >=65 years	0 Participants n=32 Participants • unit was periodontal pocket - one side of the jaw (left or right), not whole patient
Sex: Female, Male Female	18 Participants n=32 Participants • unit was periodontal pocket - one side of the jaw (left or right), not whole patient
Sex: Female, Male Male	14 Participants n=32 Participants • unit was periodontal pocket - one side of the jaw (left or right), not whole patient
Region of Enrollment Serbia	32 participants n=32 Participants • unit was periodontal pocket - one side of the jaw (left or right), not whole patient
mean value of periodontal pockets on one side of the jaw	32 periodontal pocket STANDARD_DEVIATION 0 • n=64 periodontal pocket

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Depth-PPD	3.735 mm Standard Deviation 0.863	3.696 mm Standard Deviation 0.851

PRIMARY outcome

Timeframe: after 1 month

assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Depth-PPD - 1m	2.398 mm Standard Deviation 0.792	2.876 mm Standard Deviation 0.804

PRIMARY outcome

Timeframe: after 3 months

assessment of periodontal pocket depth by probing, mean value of periodontal pockets on one side of the jaw

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Depth-PPD - 3m	1.990 mm Standard Deviation 0.640	2.567 mm Standard Deviation 0.701

PRIMARY outcome

Timeframe: after 6 months

assessment of periodontal pocket depth by probing mean value of one side of the jaw

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Depth-PPD - 6	1.778 mm Standard Deviation 0.542	2.409 mm Standard Deviation 0.640

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Level of Gingival Margin-LGM	1.737 mm Standard Deviation 0.567	1.787 mm Standard Deviation 0.589

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Level of Gingival Margin-LGM - 1m	0.948 mm Standard Deviation 0.573	1.150 mm Standard Deviation 0.462

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Level of Gingival Margin-LGM - 3m	0.782 mm Standard Deviation 0.580	0.877 mm Standard Deviation 0.533

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Level of Gingival Margin-LGM - 6m	0.808 mm Standard Deviation 0.518	0.794 mm Standard Deviation 0.457

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

assessment of clinical attachment level- CAL by probing

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Clinical Attachment Level- CAL	2.009 mm Standard Deviation 0.724	2.018 mm Standard Deviation 0.715

PRIMARY outcome

Timeframe: after 1 month

assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Clinical Attachment Level- CAL - 1m	1.453 mm Standard Deviation 0.643	1.755 mm Standard Deviation 0.654

PRIMARY outcome

Timeframe: after 3 months

assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Clinical Attachment Level- CAL - 3m	1.237 mm Standard Deviation 0.610	1.619 mm Standard Deviation 0.618

PRIMARY outcome

Timeframe: after 6 months

assessment of clinical attachment level- CAL by probing, mean value of one side of the jaw

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Clinical Attachment Level- CAL - 6m	1.226 mm Standard Deviation 0.580	1.585 mm Standard Deviation 0.619

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Bleeding on Probing-BOP	1.418 score on a scale Standard Deviation 0.714	1.345 score on a scale Standard Deviation 0.711

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Bleeding on Probing-BOP - 1m	0.649 score on a scale Standard Deviation 0.454	1.005 score on a scale Standard Deviation 0.562

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Bleeding on Probing-BOP 3m	0.298 score on a scale Standard Deviation 0.280	0.601 score on a scale Standard Deviation 0.392

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Bleeding on Probing-BOP - 6m	0.098 score on a scale Standard Deviation 0.090	0.257 score on a scale Standard Deviation 0.167

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Plaque Index- PI	1.231 score on a scale Standard Deviation 0.559	1.241 score on a scale Standard Deviation 0.565

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Plaque Index- PI -1m	0.255 score on a scale Standard Deviation 0.202	0.250 score on a scale Standard Deviation 0.185

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Plaque Index- PI -3m	0.236 score on a scale Standard Deviation 0.254	0.212 score on a scale Standard Deviation 0.182

PRIMARY outcome

Timeframe: after 6 months

visual assessment of plaque index-PI and by probing

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Plaque Index- PI - 6m	0.199 score on a scale Standard Deviation 0.185	0.203 score on a scale Standard Deviation 0.184

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) at baseline

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) Presence of microorganism	24 GCF- periodontal pocket	24 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) Absence of mimcroorganism	6 GCF- periodontal pocket	6 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 1 month

Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 1 month

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m Presence of microorganism	5 GCF- periodontal pocket	18 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) -1m Absence of mimcroorganism	25 GCF- periodontal pocket	12 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 3 months

Number of periodontal pockets with presence/absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) after 3 months

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m Presence of microorganism	8 GCF- periodontal pocket	16 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 3m Absence of mimcroorganism	22 GCF- periodontal pocket	14 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 6 months

Number of periodontal pockets with presence/absence of Aggregatibacter actinomycetemcomitans in gingival crevicular fluid (GCF) after 6 months

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m Presence of microorganism	17 GCF- periodontal pocket	19 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Aggregatibacter Actinomycetemcomitans (Aa) in Gingival Crevicular Fluid (GCF) - 6m Absence of mimcroorganism	13 GCF- periodontal pocket	11 GCF- periodontal pocket

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) at baseline

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) Presence of microorganism	30 GCF- periodontal pocket	30 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) Absence of mimcroorganism	0 GCF- periodontal pocket	0 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 1 month

Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid (GCF) after 1 month

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m Presence of microorganism	12 GCF- periodontal pocket	28 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 1m Absence of mimcroorganism	18 GCF- periodontal pocket	2 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 3 months

Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 3 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m Presence of microorganism	21 GCF- periodontal pocket	27 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 3m Absence of mimcroorganism	9 GCF- periodontal pocket	3 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 6 months

Number of periodontal pockets with presence/absence of Porphyromonas gingivalis - Pg in gingival crevicular fluid after 6 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m Absence of mimcroorganism	2 GCF- periodontal pocket	1 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Porphyromonas Gingivalis (Pg) in Gingival Crevicular Fluid (GCF) - 6m Presence of microorganism	28 GCF- periodontal pocket	29 GCF- periodontal pocket

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) at baseline

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) Presence of microorganism	27 GCF- periodontal pocket	27 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) Absence of mimcroorganism	3 GCF- periodontal pocket	3 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 1 month

Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 1 month.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m Presence of microorganism	12 GCF- periodontal pocket	23 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -1m Absence of mimcroorganism	18 GCF- periodontal pocket	7 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 3 months

Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 3 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m Presence of microorganism	17 GCF- periodontal pocket	20 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) - 3m Absence of mimcroorganism	13 GCF- periodontal pocket	10 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 6 months

Number of periodontal pockets with presence/absence of Prevotella intermedia-Pi in gingival crevicular fluid (GCF) after 6 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m Presence of microorganism	22 GCF- periodontal pocket	24 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Prevotella Intermedia (Pi) in Gingival Crevicular Fluid (GCF) -6m Absence of mimcroorganism	8 GCF- periodontal pocket	6 GCF- periodontal pocket

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) at baseline

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) Presence of microorganism	24 GCF- periodontal pocket	24 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) Absence of mimcroorganism	6 GCF- periodontal pocket	6 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 1 month

Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 1 month.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m Absence of mimcroorganism	23 GCF- periodontal pocket	7 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 1m Presence of microorganism	7 GCF- periodontal pocket	23 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 3 months

Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 3 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m Presence of microorganism	11 GCF- periodontal pocket	24 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 3m Absence of mimcroorganism	19 GCF- periodontal pocket	6 GCF- periodontal pocket

PRIMARY outcome

Timeframe: after 6 months

Number of periodontal pockets with presence/absence of Tannerella forsythia-Tf in gingival crevicular fluid (GCF) after 6 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m Presence of microorganism	17 GCF- periodontal pocket	24 GCF- periodontal pocket
Number of Periodontal Pockets With Presence/Absence of Tannerella Forsythia (Tf) in Gingival Crevicular Fluid (GCF) - 6m Absence of mimcroorganism	13 GCF- periodontal pocket	6 GCF- periodontal pocket

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Microorganisms	2408369.00 copy number Standard Deviation 3488796.726	2372881.00 copy number Standard Deviation 3483340.472

PRIMARY outcome

Timeframe: after 1 month

The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 1 month.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Microorganisms -1m	27708.86 copy number Standard Deviation 60036.838	323142 copy number Standard Deviation 458640

PRIMARY outcome

Timeframe: after 3 months

The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 3 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Microorganisms - 3m	825098.93 copy number Standard Deviation 4246296.647	226048.10 copy number Standard Deviation 680604

PRIMARY outcome

Timeframe: after 6 months

The concentration of periodontal pocket microorganisms determined in gingival crevicular fluid (GCF) by qPCR-real time after 6 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Periodontal Pocket Microorganisms - 6m	71493.73 copy number Standard Deviation 95627.954	336812.27 copy number Standard Deviation 1057691

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Tumor Necrosis Factor Alpha-TNF-α	0.925 pg/µl Standard Deviation 0.109	0.918 pg/µl Standard Deviation 0.105

PRIMARY outcome

Timeframe: after 1 month

The concentration of Tumor necrosis factor alpha-TNF-α in GCF using ELISA Kit

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Tumor Necrosis Factor Alpha-TNF-α -1m	0.382 pg/µl Standard Deviation 0.040	0.782 pg/µl Standard Deviation 0.092

PRIMARY outcome

Timeframe: after 3 months

The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 3 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Tumor Necrosis Factor Alpha-TNF-α - 3m	0.259 pg/µl Standard Deviation 0.040	0.587 pg/µl Standard Deviation 0.104

PRIMARY outcome

Timeframe: after 6 months

The concentration of Tumor necrosis factor alpha-TNF-α using ELISA Kit after 6 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Tumor Necrosis Factor Alpha-TNF-α -6m	0.238 pg/µl Standard Deviation 0.034	0.456 pg/µl Standard Deviation 0.072

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Matrix Metalloproteinase 8 - MMP-8	11.315 pg/ml Standard Deviation 1.741	11.336 pg/ml Standard Deviation 1.720

PRIMARY outcome

Timeframe: after 1 month

The concentration of Matrix metalloproteinase 8 - MMP-8 in GCF using ELISA Kit after 1 month.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Matrix Metalloproteinase 8 - MMP-8 -1m	7.906 pg/ml Standard Deviation 1.356	9.964 pg/ml Standard Deviation 1.488

PRIMARY outcome

Timeframe: after 3 months

The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 3 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Matrix Metalloproteinase 8 - MMP-8 - 3m	6.010 pg/ml Standard Deviation 1.357	9.061 pg/ml Standard Deviation 1.364

PRIMARY outcome

Timeframe: after 6 months

The concentration of Matrix metalloproteinase 8 - MMP-8 using ELISA Kit after 6 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Matrix Metalloproteinase 8 - MMP-8 - 6m	4.681 pg/ml Standard Deviation 1.465	8.642 pg/ml Standard Deviation 1.303

PRIMARY outcome

Timeframe: baseline measure (before the intervention)

The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Alkaline Phosphatase - ALP	280.496 pg/ml Standard Deviation 95.941	280.852 pg/ml Standard Deviation 96.263

PRIMARY outcome

Timeframe: after 1 month

The concentration of Alkaline phosphatase - ALP in GCF using ELISA Kit after 1 month.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Alkaline Phosphatase - ALP -1m	116.936 pg/ml Standard Deviation 37.529	199.666 pg/ml Standard Deviation 76.413

PRIMARY outcome

Timeframe: after 3 months

The concentration of Alkaline phosphatase - ALP using ELISA Kitafter 3 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Alkaline Phosphatase - ALP -3m	145.716 pg/ml Standard Deviation 49.959	216.835 pg/ml Standard Deviation 79.486

PRIMARY outcome

Timeframe: after 6 months

The concentration of Alkaline phosphatase - ALP using ELISA Kit after 6 months.

Outcome measures

Measure	SRP + Injectable Platelet-Rich Fibrin n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with Injectable Platelet-Rich Fibrin	SRP + Placebo n=30 GCF- periodontal pocket The side of the mouth which will be treated with scaling and root planing in conjunction with saline
Alkaline Phosphatase - ALP -6m	237.554 pg/ml Standard Deviation 79.872	268.905 pg/ml Standard Deviation 90.331

Adverse Events

SRP + Injectable Platelet-Rich Fibrin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SRP + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mila Vuckovic

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

Phone: +381637060694

Email: jovanovic.dr.mila@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place