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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Periodontal Intrabony Defects With Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB_PRF)

NCT06798116

Periodontal Bone Loss Periodontitis Stage III Intra-bony Pockets

ENROLLING_BY_INVITATION NA

Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

NCT04100798

Intrabony Periodontal Defect

COMPLETED NA

Injectable Platelet Rich Fibrin With Demineralized Freeze-dried Bone Allograft in Treatment of Intraosseous Defects

NCT03900013

Intrabony Periodontal Defect

UNKNOWN NA

The Use of Adhesion Molecule Loaded Hydrogel With Minimally Invasive Surgical Technique in Treatment of Periodontal Intrabony Defect

NCT05653245

Periodontitis

COMPLETED PHASE1/PHASE2

Evaluation of Healing of Intra-bony Defects in Modified Minimal Invasive Surgical Technique

NCT03562039

Periodontal Regeneration, Clinical and Radiographic Results, Modified Minimal Invasive Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intrabony Periodontal Defect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Due to the type of intervention, only the outcome assessor and the statistician will be blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Albumin Platelet Rich Fibrin (Alb-PRF)

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Albumin-PRF will be placed into intrabony defect

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.

Group Type ACTIVE_COMPARATOR

Minimally invasive surgical technique (MIST)

Intervention Type PROCEDURE

MIST will be the surgical access for treatment of Intrabony defect

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Albumin-PRF will be placed into intrabony defect

Intervention Type PROCEDURE

Minimally invasive surgical technique (MIST)

MIST will be the surgical access for treatment of Intrabony defect

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.