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Completed

NCT Number: NCT04576468

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Ain shams University

Cairo, 1156, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Flap debridement

Procedure

Surgical intevention

Other names: OFD

perforated membrane

Procedure

surgical intervention

Other names: perforated guided tissue membrane, regenerative surgery

leucocyte - platelet rich fibrin

Procedure

surgical intervention

Other names: L-PRF, regenerative surgery

Primary outcomes

  1. clinical attachement level gain

    Time frame: 6 month

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

Secondary outcomes

  1. radiographic bone fill

    Time frame: 6 month

    measured using standardized periapical radiograph change from baseline at 6 month

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Future University in Egypt

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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