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

Periodontal Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576468
• Other study ID #: FDAS-RecIM011735
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Procedure:
• Open flap debridement
Surgical intevention
• perforated membrane
surgical intervention
• leucocyte - platelet rich fibrin
surgical intervention

Locations

Country	Name	City	State
Egypt	Faculty of dentistry Ain shams University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical attachement level gain	measured using University of North Carolina Periodontal probe change from baseline at 6 month	6 month
Secondary	radiographic bone fill	measured using standardized periapical radiograph change from baseline at 6 month	6 month