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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Intrabony Periodontal Defect

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06297577

MASH2024

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Albumin Platelet Rich Fibrin (Alb-PRF)

Experimental group

Description:

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

Treatment:

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

Minimally Invasive Surgical Technique (MIST)

Active Comparator group

Description:

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.

Treatment:

Procedure: Minimally invasive surgical technique (MIST)