Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients

NCT06297577 | Not Yet Recruiting

• 1 other identifier: MASH2024
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are: will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.

Conditions

Intrabony Periodontal Defect

Keywords

Albumin Platelet Rich Fibrin (Alb-PRF); Minimally Invasive Surgical Technique (MIST); Stage 3 periodontitis; Intrabony defect

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL)

  CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.

  CAL will be measured at base line, 6, and 9 months postoperative

Secondary Outcomes (5)

• Probing Depth (PD)

  CAL will be measured at base line, 6, and 9 months postoperative

• Radiographic Linear Defect Depth (RLDD)

  Radiographic defect fill will be measured at base line, 6, and 9 months postoperative

• Recession Depth (RD)

  RD will be measured at base line, 6, and 9 months postoperative

• Post-operative Pain

  During first week postoperative

• Radiographic defect fill (RDF)

  Radiographic defect fill will be measured at base line, 6, and 9 months postoperative

Study Arms (2)

Albumin Platelet Rich Fibrin (Alb-PRF)

EXPERIMENTAL

For the production of Alb-PRF membrane, two 10 ml vacuum plastic tubes will be centrifuged at 700 g for 8 minutes. After centrifugation, the upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet-poor plasma (PPP) will be collected in a syringe and then will be heated in a heat block device at 75°C for 10 minutes to create denatured albumin (albumin gel). After heating, the albumin gel will be cooled to room temperature for approximately 10 minutes. An injectable albumin gel was then prepared. The liquid platelet-rich layer (liquid-PRF), including the buffy coat layer with accumulated platelets, leukocytes and growth factors, will be collected in a separate syringe and will be reserved at room temperature (20°C). The albumin gel and liquid PRF will be then thoroughly mixed by utilizing a female-female luer lock connector

Procedure: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)

Minimally Invasive Surgical Technique (MIST)

ACTIVE COMPARATOR

Surgical approach will be the Minimally Invasive Surgical Technique (MIST) approach according to; simplified or modified papilla-preservation flap design upon the papilla width. Defects will be thoroughly debrided using Gracey curettes and ultrasonic scalers. Then, a single internal mattress suture using 5-0 polypropylene sutures will be placed at the defect-associated inter-dental area.

Procedure: Minimally invasive surgical technique (MIST)

Interventions

Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST) PROCEDURE

Albumin-PRF will be placed into intrabony defect

Albumin Platelet Rich Fibrin (Alb-PRF)

Minimally invasive surgical technique (MIST) PROCEDURE

MIST will be the surgical access for treatment of Intrabony defect

Minimally Invasive Surgical Technique (MIST)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area.
• Vital teeth.
• No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
• No periodontal therapy carried out in the past 6 months.
• Ability to sign an informed consent form.
• Patients age ≥18 years old.
• Patients who are cooperative, motivated, and hygiene conscious.
• Systemically free according to Cornell Medical Index.

You may not qualify if:

• Patient undergoing orthodontic treatment.
• Pregnant females or breast feeding.
• Smokers.
• Teeth mobility greater than grade I.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (6)

• Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20.

  PMID: 31959025 RESULT

• Miron RJ, Chai J, Fujioka-Kobayashi M, Sculean A, Zhang Y. Evaluation of 24 protocols for the production of platelet-rich fibrin. BMC Oral Health. 2020 Nov 7;20(1):310. doi: 10.1186/s12903-020-01299-w.

  PMID: 33160335 RESULT

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 RESULT

• Pavlovic V, Ciric M, Jovanovic V, Trandafilovic M, Stojanovic P. Platelet-rich fibrin: Basics of biological actions and protocol modifications. Open Med (Wars). 2021 Mar 22;16(1):446-454. doi: 10.1515/med-2021-0259. eCollection 2021.

  PMID: 33778163 RESULT

• Alshoiby MM, Fawzy El-Sayed KM, Elbattawy W, Hosny MM. Injectable platelet-rich fibrin with demineralized freeze-dried bone allograft compared to demineralized freeze-dried bone allograft in intrabony defects of patients with stage-III periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jul;27(7):3457-3467. doi: 10.1007/s00784-023-04954-y. Epub 2023 Mar 31.

  PMID: 37002441 RESULT

• Gheno E, Mourao CFAB, Mello-Machado RC, Stellet Lourenco E, Miron RJ, Catarino KFF, Alves AT, Alves GG, Calasans-Maia MD. In vivo evaluation of the biocompatibility and biodegradation of a new denatured plasma membrane combined with liquid PRF (Alb-PRF). Platelets. 2021 May 19;32(4):542-554. doi: 10.1080/09537104.2020.1775188. Epub 2020 Jun 12.

  PMID: 32531175 RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Manal Hosny, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mashaal Mohammed, Master

CONTACT

00201094483995; mashaal.abdullah@dentistry.cu.edu.eg

Manal Hosny, Professor

CONTACT

manhosny@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the type of intervention, only the outcome assessor and the statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 7, 2024
• Study Start: August 30, 2024
• Primary Completion: August 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share