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

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?

• 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.
• 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.

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