The Added Benefit of L-PRF to Autogenous Bone Graft in the Treatment of Degree II Furcation Involvements in Mandibular Molars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Horizontal Clinical Attachment Gain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •systemic diseases;
- •medications affecting periodontal status during the previous 6 months;
- •pregnant or lactating;
- •periodontal therapy in the 2 previous years;
- •periapical endodontic lesions;
- •dental mobility.
结局指标
主要结局
Horizontal Clinical Attachment Gain
时间窗: 6 months
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.
次要结局
- Vertical Bone Level(6 months)
- Vertical Clinical Attachment Gain(6 months)
- Pocket Probing Depth(6 months)
- Gingival recession(6 months)
研究者
Michele Paolantonio
full time professor
G. d'Annunzio University