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

December 7, 2025 updated by: Wong Hong Zhang, Mahsa University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Jenjarum, Selangor, Malaysia, 42610
        • Recruiting
        • Faculty of Dentistry, MAHSA University
        • Contact:
        • Principal Investigator:
          • Hong Zhang Wong, DDS (MAHSA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control half of mouth
Normal saline irrigation after root debridement
Procedure: Normal saline irrigation
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
Experimental: Experimental half of mouth
Liquid S-PRF irrigation after root debridement
Drug: Platelet rich fibrin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal probing depth
Time Frame: Baseline immediately before treatment and 3-months post-operative
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
Time Frame: Baseline immediately before treatment and 3-months post-operative
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
Time Frame: Baseline immediately before treatment and 3-months post-operative
Record of scored, assessed bleeding after periodontal probing
Baseline immediately before treatment and 3-months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full mouth plaque score
Time Frame: Baseline immediately before treatment and monthly up to 3-months post-operative
Record of assessed plaque presence in percentage of all sites and total score using Plaque Index System
Baseline immediately before treatment and monthly up to 3-months post-operative
Full mouth bleeding score
Time Frame: Baseline immediately before treatment and monthly up to 3-months post-operative
Record of assessed bleeding on probing in percentage of all sites and total score using modified Sulcular Bleeding Index
Baseline immediately before treatment and monthly up to 3-months post-operative
Gingival margin level & relative clinical attachment level
Time Frame: Baseline immediately before treatment and 3-months post-operative
Measurement of 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahsa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC/MAR/2024/EC16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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