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

March 14, 2024 updated by: Mashaal Mohammed Abdullah Mohammed, Cairo University

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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)
Albumin-PRF will be placed into intrabony defect
Active Comparator: Platelet Rich Fibrin (PRF)
Cubital venous blood will be drawn from the patient w into 10 ml vacuum tubes and immediately will be centrifuged at 700g for 8 minutes, then will be allowed to rest for 5 minutes in PRF dish. The PRF'clot' still in gel condition will be removed from the tube, cleaned of red blood cells and then placed in intrabony defect .
Procedure: Platelet Rich Fibrin (PRF) combined with minimally invasive surgical technique (MIST)
PRF will be placed into intrabony defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level (CAL)
Time Frame: CAL will be measured at base line, 6, and 12 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.
CAL will be measured at base line, 6, and 12 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth (PD)
Time Frame: CAL will be measured at base line, 6, and 12 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.
CAL will be measured at base line, 6, and 12 months postoperative
Radiographic Linear Defect Depth (RLDD)
Time Frame: Radiographic defect fill will be measured at base line, 6, and 12 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)
Radiographic defect fill will be measured at base line, 6, and 12 months postoperative
Recession Depth (RD)
Time Frame: RD will be measured at base line, 6, and 12 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.
RD will be measured at base line, 6, and 12 months postoperative
Post-operative Pain
Time Frame: During first week postoperative
The visual analogue scale (VAS) score (0-10)
During first week postoperative
Radiographic defect fill (RDF)
Time Frame: Radiographic defect fill will be measured at base line, 6, and 12 months postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Manal Hosny, Professor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MASH2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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