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Added Benefit of L-PRF to Autogenous Bone Graft in the Treatment of Mandibular Degree II Furcation Defects

NCT03756493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-09-14

No results posted yet for this study

Summary

Different therapeutic approaches have been proposed for the treatment of furcation defects and the regeneration of periodontium within the furcation area is considered one of the most challenging aspect of surgical periodontal therapy.

Periodontal regeneration is a highly predictable therapeutic option for the treatment of different furcation defects, particularly class II furcation involvements in the lower molars.

In particular, the application of a combined therapeutic approach (i.e., barrier, bone re-placement graft with or without biological agents) seems to offer better results as compared with monotherapeutic treatments.

Several studies have demonstrated that platelet concentrates, such as platelet-rich plasma (PRP), platelet-derived growth factor (PDGF) and, more recently, leukocyte and platelet-rich fibrin (L-PRF) can represent new therapeutic options for bone regeneration procedures by increasing the healing potential of natural blood clot in the surgical site.

Leukocyte and Platelet-rich fibrin (L-PRF) is a second-generation platelet concentrate, developed by Choukroun et al. It is prepared without the addition of any anticoagulants and consists of a slowly polymerized complex fibrin network which incorporates leukocytes, glycan chains, structural glycoproteins and an high concentration of growth factors such as transforming growth factor β (TGF-B), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF). The three-dimensional architecture and the specific biochemical properties, which facilitate the wound healing processes, have led to a widespread use of this biomaterial in plastic surgery, maxillofacial surgery, oral and periodontal surgery.

A large clinical and histological evidence supports the concept that autogenous bone grafts (ABG) are highly effective regenerative materials in the treatment of intrabony defects. Moreover, with respect to the treatment of furcation defects, outcome data from a number of studies generally indicate positive clinical benefits with the use of bone grafts in the treatment of Class II furcations.

Therefore, on the basis of such considerations, the aim of this study was to evaluate the effectiveness of a combined regenerative treatment by L- PRF and ABG in the treatment of mandibular molars degree II furcation defects and to compare the outcomes of such a treatment with those from (OFD)+ABG and OFD alone treatments.

Conditions

  • Periodontal Attachment Loss
  • Periodontal Bone Loss

Interventions

PROCEDURE

Periodontal Surgery with OFD+ABG+L-PRF

Patients will be treated by periodontal surgical flaps with the addition of L-PRF+ Autogenous Bone Graft filling material.

PROCEDURE

Periodontal Surgery with OFD+ABG

Patients will be treated by periodontal surgical flaps with the addition of Autogenous Bone Graft filling material.

PROCEDURE

Periodontal Surgery OFD

Patients will be treated by Open Flap Debridement without use of filling material.

Sponsors & Collaborators

  • G. d'Annunzio University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2020-05-04
Completion
2020-05-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756493 on ClinicalTrials.gov