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

Not Applicable

Not yet recruiting

• Conditions: Intrabony Periodontal Defect
• Interventions: Procedure: Minimally invasive surgical technique (MIST); Procedure: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)

• Registration Number: NCT06297577
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Start: 2024-08-30
• Primary Completion: 2025-08-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimally Invasive Surgical Technique (MIST)	Minimally invasive surgical technique (MIST)	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.
Albumin Platelet Rich Fibrin (Alb-PRF)	Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)	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

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	CAL will be measured at base line, 6, and 9 months postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Probing Depth (PD)	CAL will be measured at base line, 6, and 9 months postoperative	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.
Radiographic Linear Defect Depth (RLDD)	Radiographic defect fill will be measured at base line, 6, and 9 months postoperative	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)
Recession Depth (RD)	RD will be measured at base line, 6, and 9 months postoperative	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.
Post-operative Pain	During first week postoperative	The visual analogue scale (VAS) score (0-10)
Radiographic defect fill (RDF)	Radiographic defect fill will be measured at base line, 6, and 9 months postoperative	Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values