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

Intrabony Periodontal Defect Clinical Trial

Official title:

Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intrabony Defect in Stage-III Periodontitis Patients A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297577
• Other study ID #: MASH2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Mashaal Mohammed, Master
• Phone: 00201094483995
• Email: mashaal.abdullah[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 30, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrabony Periodontal Defect
• Periodontitis

Intervention

Procedure:
• Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)
Albumin-PRF will be placed into intrabony defect
• Platelet Rich Fibrin (PRF) combined with minimally invasive surgical technique (MIST)
PRF will be placed into intrabony defect

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (6)

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 ra — View 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( — View 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). — View 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. — View 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, N — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 12 months postoperative
Secondary	Probing Depth (PD)	PD will be measured from the gingival margin 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 12 months postoperative
Secondary	Radiographic Linear Defect Depth (RLDD)	Individually customized bite blocks will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. Periapical radiograph PSP sensor size two and standardized exposure setting of 60 kVp, 8 mA, 0.7 mm, and 0.10 s will be used. RLDD will be measured as the depth of the intrabony defect from the alveolar crest (AC) to the defect base (DB)	Radiographic defect fill will be measured at base line, 6, and 12 months postoperative
Secondary	Recession Depth (RD)	RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth.	RD will be measured at base line, 6, and 12 months postoperative
Secondary	Post-operative Pain	The visual analogue scale (VAS) score (0-10)	During first week postoperative
Secondary	Radiographic defect fill (RDF)	Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values	Radiographic defect fill will be measured at base line, 6, and 12 months postoperative