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Periodontitis Stage IIPhase 2NCT07293962

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

A Phase 2 study testing Normal saline irrigation and Platelet rich fibrin in people with Periodontitis Stage II and Periodontitis Stage III, run by Mahsa University at 1 site in Malaysia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Normal saline irrigation and Platelet rich fibrin
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteMalaysia
Study dates
1 Apr 2024to Mar 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Malaysia1 site, 1 recruiting

  • Faculty of Dentistry, MAHSA University

    Jenjarum, Selangor, 42610

    Postgraduate Clinic Registration Counter, +60351022329, dean_dentistry@mahsa.edu.my

    Hong Zhang Wong, DDS (MAHSA)

    Recruiting

Other trials in Malaysia

About this study

Official title: Liquid S-Platelet Rich Fibrin as a Potential Adjunct in Conservative Closed Periodontal Debridement for Periodontitis Stages II-IV: A Randomized, Split-mouth, 3-month Clinical Trial

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.

Read the detailed description

Introduction: We appreciate your participation in the present study. This study is to investigate the effect of a processed blood product in healing after treatment for severe gum disease.

What is the purpose of this study? This study will test the efficacy of a biomaterial made by processing blood drawn from the participant's own arm that may improve healing once inserted into diseased gum pockets. For comparison, the other material used will be saline, which together with scaling \& root debridement forms the basic standard of care protocol for the treatment of periodontitis.

What are the procedures to be followed? Clinical examination will be done on all the participants to screen and check for the suitability to be included as a participant for the project. Panoramic X-ray radiograph(s) will be taken to see the bone height underneath the gums. Included participants will be given oral care instructions \& kit, and have alginate molds taken of their upper \& lower jaws for making a custom guide. The first appointment will be given for scaling \& root debridement with local numbing agent in one day. Towards the end of the treatment, 20 mℓ of blood will be collected from a vein in either arm. The blood will be processed to produce a liquid material that will be irrigated into tested gum pockets. For the other tested sites, saline irrigation will be performed instead. Then, appointment are given at monthly interval to review the results of the treatment until 3 months. Follow-up care will then be provided as necessary, outside the scope of this study.

Who should enter the study? Compliant adults with severe gum disease and having at least 20 teeth. What will be the benefits of the study?

  1. To you as a subject? The blood-derived biomaterial may improve gum healing compared to natural unassisted process. The involved procedures will be performed free-of-charge worth around RM 500-4000 as a token of appreciation for your participation. Stipend per appointment will be provided for travel expenses.
  2. To the investigator? The investigator can evaluate the clinical parameter.

What are the possible drawbacks? Blood-drawing is required.

Will there be complications? For blood drawing, the risks are not limited to but include risk of injuries, bruising, swelling, infection, and allergic reaction.

For scaling, the risks are not limited to but include risk of choking, accidental swallowing, bleeding, injury to adjacent structures, teeth sensitivity, teeth mobility, recession, swelling, fever, infection, and flare-up in between appointments.

For local numbing agent (anesthesia), the risks are not limited to but include risk of bleeding, swelling, choking, accidentally biting own lips, cheeks, \&/or tongue, difficulty swallowing \&/or breathing, injury to adjacent structures, nerve injury, inability to close eyes, inability to open mouth, and allergic reaction.

For root debridement, the risks are not limited to but include risk of bleeding, injury to adjacent structures, teeth sensitivity, teeth mobility, recession, swelling, fever, infection, and flare-up in between appointments.

Being tested
Normal saline irrigation, Platelet rich fibrin
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
Medical subject headings
Periodontitis, Chronic Periodontitis, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal saline irrigationProcedure or surgery

    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

  • Platelet rich fibrinDrug

    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

Study groups in NCT07293962
Study groupRoleWhat they receive
Control half of mouthPlacebo comparatorNormal saline irrigation after root debridement
Receives: Procedure: Normal saline irrigation
Experimental half of mouthExperimentalLiquid S-PRF irrigation after root debridement
Receives: Drug: Platelet rich fibrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Periodontal probing depth

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

    Measured: Baseline immediately before treatment and 3-months post-operative

  2. 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

    Measured: Baseline immediately before treatment and 3-months post-operative

  3. Number of bleeding sites

    Record of scored, assessed bleeding after periodontal probing

    Measured: Baseline immediately before treatment and 3-months post-operative

Secondary outcomes (3)

  1. Full mouth plaque score

    Record of assessed plaque presence in percentage of all sites and total score using Plaque Index System

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

  2. Full mouth bleeding score

    Record of assessed bleeding on probing in percentage of all sites and total score using modified Sulcular Bleeding Index

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

  3. Gingival margin level & relative clinical attachment level

    Measurement of marginal gingiva level from cementoenamel junction to gingival margin using UNC-15 probe with and without research stent

    Measured: Baseline immediately before treatment and 3-months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start1 Apr 2024
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Prospective split-mouth, single-blind, randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293962
Sponsor's protocol ID
RMC/MAR/2024/EC16
Status last verified
Dec 2025
First submitted
7 Dec 2025
Last updated
19 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32321052

  • 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.

    PubMed 31912527

  • 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.

    PubMed 34816309

  • 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.

    PubMed 36691719

  • 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.

    PubMed 34687113

  • 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.

    PubMed 38153510

  • 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.

    PubMed 37749861

  • 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.

    PubMed 34076375

  • 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.

    PubMed 28437133

  • 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.

    PubMed 29509050

  • 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.

    PubMed 29071440

  • 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.

    PubMed 28283682

  • 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.

    PubMed 34722331

  • 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.

    PubMed 31160643

  • 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.

    PubMed 27587367

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Normal saline irrigation and Platelet rich fibrin in people with Periodontitis Stage II and Periodontitis Stage III, run by Mahsa University at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periodontal probing depth (time frame: Baseline immediately before treatment and 3-months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07293962, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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