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

NCT ID: NCT04576468

Last Updated: 2020-10-08

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients equally distributed into 4 groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open flap debridement

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

Group Type EXPERIMENTAL

Open flap debridement

Intervention Type PROCEDURE

Surgical intevention

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.

Group Type EXPERIMENTAL

Open flap debridement

Intervention Type PROCEDURE

Surgical intevention

perforated membrane

Intervention Type PROCEDURE

surgical intervention

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.

Group Type EXPERIMENTAL

Open flap debridement

Intervention Type PROCEDURE

Surgical intevention

leucocyte - platelet rich fibrin

Intervention Type PROCEDURE

surgical intervention

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.

Group Type EXPERIMENTAL

Open flap debridement

Intervention Type PROCEDURE

Surgical intevention

perforated membrane

Intervention Type PROCEDURE

surgical intervention

leucocyte - platelet rich fibrin

Intervention Type PROCEDURE

surgical intervention

Interventions

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Open flap debridement

Surgical intevention

Intervention Type PROCEDURE

perforated membrane

surgical intervention

Intervention Type PROCEDURE

leucocyte - platelet rich fibrin

surgical intervention

Intervention Type PROCEDURE

Other Intervention Names

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OFD perforated guided tissue membrane regenerative surgery L-PRF regenerative surgery

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Samir

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Y Gamal, Professor

Role: STUDY_DIRECTOR

Faculty of dentistry - Ain shams University

Locations

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Faculty of dentistry Ain shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FDAS-RecIM011735

Identifier Type: -

Identifier Source: org_study_id

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