The Use of Leucocyte Platelet Rich Fibrin (L- PRF) Covered Perforated Guided Tissue Membrane for Treatment of Periodontal Intrabony Defects

The Use of Leucocyte Platelet Rich Fibrin (L- PRF) Covered Perforated Guided Tissue Membrane for Treatment of Periodontal Intrabony Defects (Randomized Clinical Trial)

This study is the first to investigate the effect of leucocyte platelet rich fibrin (L-PRF) combined with perforated membrane in order to treat infrabony defects and assess their combined effect in clinical attachment level gain and filling of base of the defect (BD). The main hypothesis was that if the L-PRF act as a chemoattracttant for a higher number of periosteal derived periodontal cells (PDPCs) and gingival mesenchymal stem cells (GMSCs) encouraging their passage through the membrane perforations.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Open flap debridement; Procedure: perforated membrane; Procedure: leucocyte - platelet rich fibrin

Detailed Description

A randomized (controlled) clinical trial which included forty sites with intrabony interproximal defects (2- or 3-wall) premolar/molar teeth assessed for clinical parameters. The four treatment modalities were randomly allocated by a predetermined computer generated randomization list (www.randomizer.org) into four equal groups; Group I (control group) open flap debridement (OFD): included intrabony defects treated by open flap debridement (OFD).Group II perforated membrane (PM): included intrabony defects treated by perforated membranes.Group III Leucocyte-platelet rich fibrin (L-PRF): included intrabony defects treated by leukocytes platelet rich fibrin (L-PRF). Group IV Leucocyte-platelet rich fibrin + perforated membrane (L-PRF + PM): included intrabony defects treated by Leucocyte platelet rich fibrin & perforated membranes.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1156
    • Faculty of Dentistry Ain Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both genders aged from 18- 60 years.
• Patients free from any systemic diseases that may contra-indicate periodontal surgery (Ahmed Y. Gamal et al., 2014).
• Two- or three-wall intrabony defects in premolar/molar teeth without furcation involvement, that are measured from the alveolar crest to the defect bottom in diagnostic periapical radiographs of ≥ 3 mm (Reynolds et al., 2015).
• Probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm at the site of intrabony defects 4 week after the phase one therapy (Ahmed Y. Gamal et al., 2014).
• Free from any periapical pathosis.
• Patients willing and able to return for multiple follow up visits and perform oral hygiene instructions.
• Absence of occlusal interference, mobility and open interproximal contact.
• Good fulfillment to plaque control instructions following initial therapy.

Exclusion Criteria:

• Smokers.
• Pregnant and breast feeding females.
• Periodontal surgical treatment in the previous 12 months at the involved sites. (A. Y. Gamal et al., 2016)
• Persistence of gingival inflammation after phase I therapy.
• Vulnerable groups as handicapped, mentally disabled, prisoners and orphans.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: open flap debridement; envelope full thickness flap reflection, removal of granulation tissue then suturing with simple loop sutures.	Procedure: Open flap debridement; Surgical intevention; Other Names: OFD
Experimental: perforated membrane (PM); envelope full thickness flap reflection, removal of granulation tissue placing resorbable membrane after perforating it over the vertical defect then suturing with simple loop sutures.	Procedure: Open flap debridement; Surgical intevention; Other Names: OFD; Procedure: perforated membrane; surgical intervention; Other Names: regenerative surgery; perforated guided tissue membrane
Experimental: leucocyte platelet rich fibrin (L-PRF); envelope full thickness flap reflection, removal of granulation tissue after withdrawal of blood and placing it in intraspin centrifuge , placing the resulting L-PRF in the defect then suturing with simple loop sutures.	Procedure: Open flap debridement; Surgical intevention; Other Names: OFD; Procedure: leucocyte - platelet rich fibrin; surgical intervention; Other Names: regenerative surgery; L-PRF
Experimental: L-PRF + PM; envelope full thickness flap reflection, removal of granulation tissue after withdrawal of blood and placing it in intraspin centrifuge , placing the resulting L-PRF covered by resorbable membrane after perforating it in the defect then suturing with simple loop sutures.	Procedure: Open flap debridement; Surgical intevention; Other Names: OFD; Procedure: perforated membrane; surgical intervention; Other Names: regenerative surgery; perforated guided tissue membrane; Procedure: leucocyte - platelet rich fibrin; surgical intervention; Other Names: regenerative surgery; L-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical attachement level gain	measured using University of North Carolina Periodontal probe change from baseline at 6 month	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic bone fill	measured using standardized periapical radiograph change from baseline at 6 month	6 month

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Future University in Egypt
• Investigators: Study Director: Ahmed Y Gamal, Professor, Faculty of Dentistry - Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: L-PRF; perforated membrane; guided tissue regeneration; vertical defects; Intrabony defects
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: FDAS-RecIM011735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No