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

NCT03756493 | Completed

• 1 other identifier: 11042017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Platlet rich fibrin; Bone graft; Furcation defects

Outcome Measures

Primary Outcomes (1)

• Horizontal Clinical Attachment Gain

  The periodontal probe was inserted into the furcation area, perpendicular to a horizontal one which was placed on the buccal or lingual aspect of the involved tooth.

  6 months

Secondary Outcomes (4)

• Vertical Bone Level

  6 months

• Vertical Clinical Attachment Gain

  6 months

• Pocket Probing Depth

  6 months

• Gingival recession

  6 months

Study Arms (3)

OFD+ABG+L-PRF treated patients

EXPERIMENTAL

Periodontal surgery with Leukocyte and Platelet Rich Fibrin (L-PRF) is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous bone graft mixed with cutted L-PRF will be applied to the furcation defects; then, a L-PRF membrane is positioned above the filling material. Finally the flap will be coronally positionated and sutured by interrupted sutures.

Procedure: Periodontal Surgery with OFD+ABG+L-PRF

OFD+ABG treated patients

ACTIVE COMPARATOR

Periodontal surgery with Autogenous Bone Graft (ABG) is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. ABG will be applied to the furcation defects. Finally the flap will be coronally positioned and sutured by interrupted sutures.

Procedure: Periodontal Surgery with OFD+ABG

OFD treated patients

ACTIVE COMPARATOR

Periodontal surgery with Open Flap Debridement is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. No grafts will be applied to the furcation defects. Finally the flap will be coronally positioned and sutured by interrupted sutures.

Procedure: Periodontal Surgery OFD

Interventions

Periodontal Surgery with OFD+ABG+L-PRF PROCEDURE

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

OFD+ABG+L-PRF treated patients

Periodontal Surgery with OFD+ABG PROCEDURE

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

OFD+ABG treated patients

Periodontal Surgery OFD PROCEDURE

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

OFD treated patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a Full-Mouth Plaque Score (FMPS) and a Full-Mouth Bleeding Score (FMBS) \< 20% at the time of surgery;
• to have at least 20 teeth;
• at least 1 mandibular molar with buccal or lingual degree II furcation defects, with no mobility and with horizontal CAL (HCAL) \> 3 mm and vertical probing depth in the central-vestibular or central-lingual site \>= 5 mm after non surgical treatment.

You may not qualify if:

• systemic diseases;
• medications affecting periodontal status during the previous 6 months;
• pregnant or lactating;
• smokers;
• periodontal therapy in the 2 previous years;
• periapical endodontic lesions;
• dental mobility.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

MeSH Terms

Conditions

Periodontal Attachment Loss; Alveolar Bone Loss; Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full time professor

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: December 5, 2018
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

IT (1)