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

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

Overview

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.

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.

Interventions

• 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
• 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

Primary outcome measures

• Periodontal probing depth [Time frame: Baseline immediately before treatment and 3-months post-operative]
• Clinical attachment level [Time frame: Baseline immediately before treatment and 3-months post-operative]
• Number of bleeding sites [Time frame: Baseline immediately before treatment and 3-months post-operative]

Secondary outcome measures (3)

• Full mouth plaque score [Time frame: 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]
• Gingival margin level & relative clinical attachment level [Time frame: Baseline immediately before treatment and 3-months post-operative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Single blind

Primary purpose

Treatment

Study locations

Malaysia · 1 center

• Faculty of Dentistry, MAHSA University — Jenjarum

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. do PMID 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. PMID 34076375

Identifiers

NCT: NCT07293962 · RMC/MAR/2024/EC16

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗