NCT03756493

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

Completed NA Last updated 14 September 2021

What this trial tests

NA trial testing Periodontal Surgery with OFD+ABG+L-PRF in Periodontal Attachment Loss in 54 participants. Completed in 4 May 2020.

Timeline

5 December 2018

Primary endpoint
4 May 2020

4 May 2020

Quick facts

Lead sponsor	G. d'Annunzio University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	54
Start date	5 December 2018
Primary completion	4 May 2020
Estimated completion	4 May 2020
Sites	1 location across Italy

Drugs / interventions tested

• Periodontal Surgery with OFD+ABG+L-PRF
• Periodontal Surgery with OFD+ABG
• Periodontal Surgery OFD

Conditions studied

• Periodontal Attachment Loss — all drugs for Periodontal Attachment Loss →
• Periodontal Bone Loss — all drugs for Periodontal Bone Loss →

Sponsor

G. d'Annunzio University

Who can join

Adults 18 to 70, any sex, with Periodontal Attachment Loss or Periodontal Bone Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.