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

NCT04576468 | Completed DMC

• 1 other identifier: FDAS-RecIM011735
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases

Keywords

perforated membrane; L-PRF; guided tissue regeneration; vertical defects; Intrabony defects

Outcome Measures

Primary Outcomes (1)

• clinical attachement level gain

  measured using University of North Carolina Periodontal probe change from baseline at 6 month

  6 month

Secondary Outcomes (1)

• radiographic bone fill

  6 month

Study Arms (4)

open flap debridement

EXPERIMENTAL

envelope full thickness flap reflection, removal of granulation tissue then suturing with simple loop sutures.

Procedure: Open flap debridement

perforated membrane (PM)

EXPERIMENTAL

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; Procedure: perforated membrane

leucocyte platelet rich fibrin (L-PRF)

EXPERIMENTAL

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; Procedure: leucocyte - platelet rich fibrin

L-PRF + PM

EXPERIMENTAL

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; Procedure: perforated membrane; Procedure: leucocyte - platelet rich fibrin

Interventions

Open flap debridement PROCEDURE

Surgical intevention

Also known as: OFD

L-PRF + PM; leucocyte platelet rich fibrin (L-PRF); open flap debridement; perforated membrane (PM)

perforated membrane PROCEDURE

surgical intervention

Also known as: perforated guided tissue membrane, regenerative surgery

L-PRF + PM; perforated membrane (PM)

leucocyte - platelet rich fibrin PROCEDURE

surgical intervention

Also known as: L-PRF, regenerative surgery

L-PRF + PM; leucocyte platelet rich fibrin (L-PRF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• Future University in Egypt: collaborator

Study Sites (1)

Faculty of dentistry Ain shams University

Cairo, 1156, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Y Gamal, Professor

  Faculty of dentistry - Ain shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: patients equally distributed into 4 groups

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 6, 2020
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)