Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03756493 |
| Other study ID # |
11042017 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 5, 2018 |
| Est. completion date |
May 4, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
G. d'Annunzio University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Experimental Design. This randomized, comparative and clinical trial will be designed to
evaluate the clinical and radiographic outcomes 6 months after three treatment modalities of
mandibular degree II furcation defects.
The patients study will exhibit buccal or lingual mandibular degree II furcation defects; all
experimental sites will be accessed with a SPPF procedure. L- PRF and autogenous bone graft
(ABG) will be applied to the debrided defects in the OFD+ABG+L-PRF group; the OFD+ABG group
will receive only ABG and the OFD group will be treated with Open Flap Debridement (OFD)
alone.
Study Population. At least fifty-four patients, aged 18 to 70 years old, affected by
moderate-to-severe chronic periodontitis, will be selected for this study and treated at the
Operating Unit of Periodontology and Oral Hygiene of the Department of Medical, Oral and
Biotechnological Sciences, "G. D'Annunzio" Chieti-Pescara University, Italy. Each patient
will participate in the study with a single experimental site.
The participants will receive verbal and written information and will sign a consent form
approved by the Ethical Committee of the G. D'Annunzio University of Chieti medical faculty.
The study protocol is in accordance with the Declaration of Helsinki of 1975, as revised in
2013.
Each defect will be assigned a defect number and will be randomly allocated to one of the
three treatment regimens. Assignment will be performed by a custom made computer-generated
table. To conceal allocation, opaque envelops will be assigned to the specific experimental
site and will be opened during surgery.
Four months before the surgical treatment, all 54 patients will undergo non-surgical
periodontal treatment consisting of supragingival and subgingival scaling and root planing
(SRP) by ultrasonic instruments and hand curets and motivational instructions on oral home
care.
Complete oral and periodontal examinations will be performed for each patient before and 4
months after the non-surgical treatment. These will include full mouth plaque score (FMPS),
full mouth bleeding score (FMBS), probing depth (PD), vertical clinical attachment level
(VCAL), horizontal clinical attachment level (HCAL), and gingival recession (GR) for six
sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/ palatal,
mid-lingual/palatal, and disto-lingual/palatal sites). The measurements will be recorded
using a University of North Carolina (UNC-15, HuFriedy, Chicago, Illinois, USA) periodontal
probe.
Clinical measurements at mid-buccal or mid-lingual experimental sites will be taken
immediately before surgical treatment (baseline) and 6 months after treatment, by the same
experienced examiner (MP), who will be masked to the treatment. The primary outcome of the
study will be HCAL gain at 6 months.
Radiographic Measurements. Preoperative and 6 months postoperative standardized radiographs
will be taken by the paralleling technique using an individual film-holder device consisting
of a bite block rigidly connected to an acrylic dental splint to achieve identical film
placement at each evaluation.
The radiographs will be digitized using an image processing device, after choosing the
standard scan settings (600 dots per inch and 256 levels of gray).
Measurements related to vertical bone level (VBL) will be performed using a dedicated
software and calculating the distance between the furcation fornix and the bottom of the
defect.
Before surgery, from each patient of all groups, to avoid unblinding, 30 ml of blood was
collected in three 10-ml sterile tubes without anticoagulant, and it was quickly
centrifuged‖‖ at 3,000 revolutions/minute for 10 minutes.The fibrin clot (L-PRF) was
collected and squeezed in the L-PRF Box to form three membranes.
Surgical Technique. All the surgeries will be performed by the same experienced clinician. In
all groups, after local anaesthesia, mucoperiosteal SPPFs will be raised. Mesial and distal
vertical releasing incisions will be performed to allow more visibility and defects
accessibility. After flap elevation, flap mobility will be tested to ensure that primary
closure of the wound could be achieved through tension-free suturing. The granulation tissue
adherent to the alveolar bone will be removed to provide full access and visibility to the
root and bone surfaces. SRP will be performed. ABG material will be collected using bone
scrapers in OFD+ABG+L-PRF group and OFD+ABG group.
In the OFD+ABG+L-PRF group , one L-PRF membrane cutted into small pieces and mixed with ABG
will be placed in the furcation defect. The other PRF membranes in each patient will be
placed over the grafted defect and will be sutured with an absorbable suture. The OFD+ABG
group defects will be grafted only with ABG and will be not covered by a L-PRF membrane. The
OFD group defect will be treated only with open flap debridement. Finally the flap will be
repositioned and horizontal mattress and interrupted sutures will be carried out.
