3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV

NCT07293962 | Recruiting Phase 2

• 1 other identifier: RMC/MAR/2024/EC16
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

What is the purpose of this study? This study is to investigate the effect of a processed blood product in healing after treatment for gum disease. In addition to scaling \& root debridement (deep cleaning) that is the standard treatment for periodontitis, this study will test the effectiveness of patient's processed blood in improving healing of diseased gums. What are the procedures to be followed? First, all patients will undergo dental check-up and X-ray imaging for suitability as a participant for the project. For participants who are eligible and included into study, upper \& lower jaws models will be made, and each will be given oral care kit \& instructions. The next appointment will be given for scaling \& root debridement with local numbing agent in one day. Towards the end of the treatment, a small amount (20 mℓ) of blood will be collected and spun to produce liquid platelet-rich fibrin that is then used to flush the treated gum pockets in half of the mouth. For the treated gum pockets in the opposite half of the mouth, sterile salt water (saline) will be used instead for comparison. Then, follow-up appointments are at monthly intervals until 3 months. Who should enter the study? Symptoms of gum disease include bleeding and/or receding gums, tooth/teeth appearing longer or feeling shaky/loose/weak, formation of large amount of calculus and/or black/empty space between teeth, frequent/recurrent gum swelling/pus, and/or bad breath.

Conditions

Periodontitis Stage II; Periodontitis Stage III; Periodontitis (Stage 3); Periodontitis; Periodontitis Chronic Localized Slight; Periodontitis Chronic Generalized Moderate; Periodontitis Chronic Generalized Severe; Periodontitis, Adult; Periodontitis, Chronic

Keywords

periodontal treatment; periodontitis; platelet concentrates; platelet-rich fibrin; nonsurgical; clinical trial; periodontal; nonsurgical periodontal debridement; dental scaling; periodontal diseases; periodontal debridement; nonsurgical periodontal treatment

Outcome Measures

Primary Outcomes (3)

• Periodontal probing depth

  Measurement of periodontal pocket depth from gingival margin to base of pocket using UNC-15 probe with and without research stent

  Baseline immediately before treatment and 3-months post-operative

• Clinical attachment level

  Sum of measurement of periodontal pocket depth from gingival margin to base of pocket and marginal gingiva level from cementoenamel junction to gingival margin using UNC-15 probe with and without research stent

  Baseline immediately before treatment and 3-months post-operative

• Number of bleeding sites

  Record of scored, assessed bleeding after periodontal probing

  Baseline immediately before treatment and 3-months post-operative

Secondary Outcomes (3)

• Full mouth plaque score

  Baseline immediately before treatment and monthly up to 3-months post-operative

• Full mouth bleeding score

  Baseline immediately before treatment and monthly up to 3-months post-operative

• Gingival margin level & relative clinical attachment level

  Baseline immediately before treatment and 3-months post-operative

Study Arms (2)

Control half of mouth

PLACEBO COMPARATOR

Normal saline irrigation after root debridement

Procedure: Normal saline irrigation

Experimental half of mouth

EXPERIMENTAL

Liquid S-PRF irrigation after root debridement

Drug: Platelet rich fibrin

Interventions

Normal saline irrigation PROCEDURE

Full mouth scaling or professional mechanical plaque removal, air polishing, and root debridement wherever deep pockets are indicated, then normal saline irrigation after root debridement

Control half of mouth

Platelet rich fibrin DRUG

Full mouth scaling or professional mechanical plaque removal, air polishing, and root debridement wherever deep pockets are indicated, then liquid S-PRF irrigation after root debridement

Experimental half of mouth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have at least 20 teeth,
• American Society of Anesthesiology class I or II
• Periodontitis stages II-IV
• Bilateral sites of deep periodontal pockets ≥5 mm

You may not qualify if:

• Limited mouth opening or symptomatic temporomandibular joint disorder
• Inability to tolerate extended long periodontal treatment and/or hyperactive gag reflex
• Current or former smoker or vape user
• Pregnant and/or breastfeeding
• Having diabetes mellitus type I or II
• Having bleeding disorder or is on anticoagulants
• Underwent periodontal treatment and/or surgery in past 6 months prior
• Undergoing orthodontic therapy, or completed in past 3 months prior
• On or had anti-inflammatory drug(s) in past 3 months prior
• On or had antibiotic(s) in past 3 months prior
• Having autoimmune disorder
• On or had immunosuppressant drug(s) in past 3 months prior
• Undergoing or underwent radio- and/or chemo-therapy

Sponsors & Collaborators

• Mahsa University: lead

Study Sites (1)

Faculty of Dentistry, MAHSA University

Jenjarum, Selangor, 42610, Malaysia

RECRUITING

Related Publications (23)

• Panda S, Purkayastha A, Mohanty R, Nayak R, Satpathy A, DAS AC, Kumar M, Mohanty G, Panda S, Fabbro MD. Plasma rich in growth factors (PRGF) in non-surgical periodontal therapy: a randomized clinical trial. Braz Oral Res. 2020 Apr 17;34:e034. doi: 10.1590/1807-3107bor-2020.vol34.0034. eCollection 2020.

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• Loos BG, Needleman I. Endpoints of active periodontal therapy. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):61-71. doi: 10.1111/jcpe.13253.

  PMID: 31912527 BACKGROUND

• Miron RJ, Horrocks NA, Zhang Y, Horrocks G, Pikos MA, Sculean A. Extending the working properties of liquid platelet-rich fibrin using chemically modified PET tubes and the Bio-Cool device. Clin Oral Investig. 2022 Mar;26(3):2873-2878. doi: 10.1007/s00784-021-04268-x. Epub 2021 Nov 23.

  PMID: 34816309 BACKGROUND

• Al-Rihaymee S, Sh Mahmood M. The efficacy of non-surgical platelet-rich fibrin application on clinical periodontal parameters and periostin level in periodontitis: Clinical trial. J Cell Mol Med. 2023 Feb;27(4):529-537. doi: 10.1111/jcmm.17675. Epub 2023 Jan 23.

  PMID: 36691719 BACKGROUND

• Narendran N, Anegundi RV, Shenoy SB, Chandran T. Autologous platelet-rich fibrin as an adjunct to non-surgical periodontal therapy-A follow up clinical pilot study. Wound Repair Regen. 2022 Jan;30(1):140-145. doi: 10.1111/wrr.12979. Epub 2021 Oct 22.

  PMID: 34687113 BACKGROUND

• Torumtay Cin G, Lektemur Alpan A, Cevik O. Efficacy of injectable platelet-rich fibrin on clinical and biochemical parameters in non-surgical periodontal treatment: a split-mouth randomized controlled trial. Clin Oral Investig. 2023 Dec 28;28(1):46. doi: 10.1007/s00784-023-05447-8.

  PMID: 38153510 BACKGROUND

• Shunmuga PD, Tadepalli A, Parthasarathy H, Ponnaiyan D, Cholan PK, Ramachandran L. Clinical evaluation of the combined efficacy of injectable platelet-rich fibrin along with scaling and root planing in the non-surgical periodontal therapy of stage III and grade C periodontitis patients having type 2 diabetes mellitus: A randomized controlled trial. Clin Adv Periodontics. 2024 Sep;14(3):223-231. doi: 10.1002/cap.10266. Epub 2023 Sep 25.

  PMID: 37749861 BACKGROUND

• Albonni H, El Abdelah AAAD, Al Hamwi MOMS, Al Hamoui WB, Sawaf H. Clinical effectiveness of a topical subgingival application of injectable platelet-rich fibrin as adjunctive therapy to scaling and root planing: a double-blind, split-mouth, randomized, prospective, comparative controlled trial. Quintessence Int. 2021 Jul 20;52(8):676-685. doi: 10.3290/j.qi.b1492019.

  PMID: 34076375 BACKGROUND

• Dohan Ehrenfest DM, Pinto NR, Pereda A, Jimenez P, Corso MD, Kang BS, Nally M, Lanata N, Wang HL, Quirynen M. The impact of the centrifuge characteristics and centrifugation protocols on the cells, growth factors, and fibrin architecture of a leukocyte- and platelet-rich fibrin (L-PRF) clot and membrane. Platelets. 2018 Mar;29(2):171-184. doi: 10.1080/09537104.2017.1293812. Epub 2017 Apr 24.

  PMID: 28437133 BACKGROUND

• Kubesch A, Barbeck M, Al-Maawi S, Orlowska A, Booms PF, Sader RA, Miron RJ, Kirkpatrick CJ, Choukroun J, Ghanaati S. A low-speed centrifugation concept leads to cell accumulation and vascularization of solid platelet-rich fibrin: an experimental study in vivo. Platelets. 2019;30(3):329-340. doi: 10.1080/09537104.2018.1445835. Epub 2018 Mar 6.

  PMID: 29509050 BACKGROUND

• Wend S, Kubesch A, Orlowska A, Al-Maawi S, Zender N, Dias A, Miron RJ, Sader R, Booms P, Kirkpatrick CJ, Choukroun J, Ghanaati S. Reduction of the relative centrifugal force influences cell number and growth factor release within injectable PRF-based matrices. J Mater Sci Mater Med. 2017 Oct 25;28(12):188. doi: 10.1007/s10856-017-5992-6.

  PMID: 29071440 BACKGROUND

• Choukroun J, Ghanaati S. Reduction of relative centrifugation force within injectable platelet-rich-fibrin (PRF) concentrates advances patients' own inflammatory cells, platelets and growth factors: the first introduction to the low speed centrifugation concept. Eur J Trauma Emerg Surg. 2018 Feb;44(1):87-95. doi: 10.1007/s00068-017-0767-9. Epub 2017 Mar 10.

  PMID: 28283682 BACKGROUND

• Rodriguez Sanchez F, Verspecht T, Castro AB, Pauwels M, Andres CR, Quirynen M, Teughels W. Antimicrobial Mechanisms of Leucocyte- and Platelet Rich Fibrin Exudate Against Planktonic Porphyromonas gingivalis and Within Multi-Species Biofilm: A Pilot Study. Front Cell Infect Microbiol. 2021 Oct 13;11:722499. doi: 10.3389/fcimb.2021.722499. eCollection 2021.

  PMID: 34722331 BACKGROUND

• Castro AB, Herrero ER, Slomka V, Pinto N, Teughels W, Quirynen M. Antimicrobial capacity of Leucocyte-and Platelet Rich Fibrin against periodontal pathogens. Sci Rep. 2019 Jun 3;9(1):8188. doi: 10.1038/s41598-019-44755-6.

  PMID: 31160643 BACKGROUND

• Fujioka-Kobayashi M, Miron RJ, Hernandez M, Kandalam U, Zhang Y, Choukroun J. Optimized Platelet-Rich Fibrin With the Low-Speed Concept: Growth Factor Release, Biocompatibility, and Cellular Response. J Periodontol. 2017 Jan;88(1):112-121. doi: 10.1902/jop.2016.160443. Epub 2016 Sep 2.

  PMID: 27587367 BACKGROUND

• Miron RJ, Fujioka-Kobayashi M, Sculean A, Zhang Y. Optimization of platelet-rich fibrin. Periodontol 2000. 2024 Feb;94(1):79-91. doi: 10.1111/prd.12521. Epub 2023 Sep 8.

  PMID: 37681522 BACKGROUND

• Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.

  PMID: 24945603 BACKGROUND

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.

  PMID: 16504849 BACKGROUND

• Miron RJ, Gruber R, Farshidfar N, Sculean A, Zhang Y. Ten years of injectable platelet-rich fibrin. Periodontol 2000. 2024 Feb;94(1):92-113. doi: 10.1111/prd.12538. Epub 2023 Nov 30.

  PMID: 38037213 BACKGROUND

• Caruana A, Savina D, Macedo JP, Soares SC. From Platelet-Rich Plasma to Advanced Platelet-Rich Fibrin: Biological Achievements and Clinical Advances in Modern Surgery. Eur J Dent. 2019 May;13(2):280-286. doi: 10.1055/s-0039-1696585. Epub 2019 Sep 11.

  PMID: 31509878 BACKGROUND

• Herrera D, Sanz M, Kebschull M, Jepsen S, Sculean A, Berglundh T, Papapanou PN, Chapple I, Tonetti MS; EFP Workshop Participants and Methodological Consultant. Treatment of stage IV periodontitis: The EFP S3 level clinical practice guideline. J Clin Periodontol. 2022 Jun;49 Suppl 24:4-71. doi: 10.1111/jcpe.13639.

  PMID: 35688447 BACKGROUND

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946.

  PMID: 29926490 BACKGROUND

Related Links

• Process for A-PRF - Videos
• Description of S-PRF protocol
• Statement on ASA Physical Status Classification System (2020)

MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Prospective split-mouth, single-blind, randomized controlled trial

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: April 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

MY (1)