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

Mahsa University

Status and phase

Enrolling

Phase 2

Conditions

Periodontitis Stage III

Periodontitis Chronic Generalized Moderate

Periodontitis

Periodontitis Chronic Generalized Severe

Periodontitis (Stage 3)

Periodontitis Stage II

Periodontitis, Chronic

Periodontitis, Adult

Periodontitis Chronic Localized Slight

Treatments

Drug: Platelet rich fibrin

Procedure: Normal saline irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT07293962

RMC/MAR/2024/EC16

Details and patient eligibility

About

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.

Full 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?

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.

Enrollment

14 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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