Clinical trial NCT06297577: Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients
Official title: Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin (Alb-PRF) Versus Minimally Invasive Surgical Technique (MIST) in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intrabony Periodontal Defect
Keywords: Albumin Platelet Rich Fibrin (Alb-PRF)
Minimally Invasive Surgical Technique (MIST)
Stage 3 periodontitis
Intrabony defect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Vital teeth.
3. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
4. No periodontal therapy carried out in the past 6 months.
5. Ability to sign an informed consent form.
6. Patients age ≥18 years old.
7. Patients who are cooperative, motivated, and hygiene conscious.
8. Systemically free according to Cornell Medical Index.

Exclusion Criteria:

1. Patient undergoing orthodontic treatment.
2. Pregnant females or breast feeding.
3. Smokers.
4. Teeth mobility greater than grade I.

Primary outcomes:
measure: Clinical attachment level (CAL)
timeFrame: CAL will be measured at base line, 6, and 9 months postoperative
Secondary outcomes:
measure: Probing Depth (PD)
timeFrame: CAL will be measured at base line, 6, and 9 months postoperative
measure: Radiographic Linear Defect Depth (RLDD)
timeFrame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
measure: Recession Depth (RD)
timeFrame: RD will be measured at base line, 6, and 9 months postoperative
measure: Post-operative Pain
timeFrame: During first week postoperative
measure: Radiographic defect fill (RDF)
timeFrame: Radiographic defect fill will be measured at base line, 6, and 9 months postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Manal Hosny, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.