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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04576468
Enrollment
40
Registered
2020-10-06
Start date
2018-06-01
Completion date
2019-12-31
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

Keywords

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

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.

Interventions

PROCEDUREOpen flap debridement

Surgical intevention

surgical intervention

PROCEDUREleucocyte - platelet rich fibrin

surgical intervention

Sponsors

Future University in Egypt
CollaboratorOTHER
Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

patients equally distributed into 4 groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical attachement level gain6 monthmeasured using University of North Carolina Periodontal probe change from baseline at 6 month

Secondary

MeasureTime frameDescription
radiographic bone fill6 monthmeasured using standardized periapical radiograph change from baseline at 6 month

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026