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

Primary Purpose

Periodontal Diseases

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Open flap debridement

perforated membrane

leucocyte - platelet rich fibrin

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring perforated membrane, L-PRF, guided tissue regeneration, vertical defects, Intrabony defects

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Faculty of dentistry Ain shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

open flap debridement

perforated membrane (PM)

leucocyte platelet rich fibrin (L-PRF)

L-PRF + PM

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

clinical attachement level gain

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

Secondary Outcome Measures

radiographic bone fill

measured using standardized periapical radiograph change from baseline at 6 month

Full Information

NCT ID

NCT04576468

First Posted

September 28, 2020

Last Updated

October 5, 2020

Sponsor

Ain Shams University

Collaborators

Future University in Egypt

1. Study Identification

Unique Protocol Identification Number

NCT04576468

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

Collaborators

Future University in Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

patients equally distributed into 4 groups

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

open flap debridement

Arm Type

Experimental

Arm Description

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

Arm Title

perforated membrane (PM)

Arm Type

Experimental

Arm Description

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.

Arm Title

leucocyte platelet rich fibrin (L-PRF)

Arm Type

Experimental

Arm Description

Arm Title

L-PRF + PM

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Open flap debridement

Other Intervention Name(s)

OFD

Intervention Description

Surgical intevention

Intervention Type

Procedure

Intervention Name(s)

perforated membrane

Other Intervention Name(s)

perforated guided tissue membrane, regenerative surgery

Intervention Description

surgical intervention

Intervention Type

Procedure

Intervention Name(s)

leucocyte - platelet rich fibrin

Other Intervention Name(s)

L-PRF, regenerative surgery

Intervention Description

surgical intervention

Primary Outcome Measure Information:

Title

clinical attachement level gain

Description

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

Time Frame

6 month

Secondary Outcome Measure Information:

Title

radiographic bone fill

Description

measured using standardized periapical radiograph change from baseline at 6 month

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Y Gamal, Professor

Organizational Affiliation

Faculty of dentistry - Ain shams University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of dentistry Ain shams University

City

Cairo

ZIP/Postal Code

1156

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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