Periodontal Regeneration With Platelet-rich Fibrin (Prf) and Autogenous Bone Graft (Abg) Versus Enamel Matrix Derivative (Emd) and Abg in the Treatment of Intrabony Periodontal Defects a Longitudinal Randomized Control Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Periodontal attachment gain
研究概览
简要总结
Currently, the most positive documented outcomes of periodontal regenerative therapy (PRT) in intrabony defects (IBDs) have been achieved with a combination of bone grafts ( BGs) and a regeneration material like membranes in guided tissue regeneration ( GTR) or enamel matrix derivative (EMD) in Induced Periodontal Regeneration ( IPR) technique. Among the graft materials only autogenous bone grafts ( ABGs).and demineralized freeze-dried bone allografts (DFDBA), are considered regenerative materials.
Polypeptide growth factors revealed a potential application in PRT periodontal because are the biological mediators during wound healing and regeneration and autologous platelet concentrates ( PC) constitute a safe and convenient approach to deliver them.
Among PC, platelet-rich fibrin ( PRF) belongs to a group of second-generation blood autologous products prepared by peripheral blood centrifugation without any nonclotting agent, so to obtain a dense three-dimensional clot architecture that concentrates platelets, fibrin, leukocytes, cytokines, and sustain cellular migration. This clot is then compressed to obtain elastic and very strong membranes that can be used directly as membranes or as a filling agent, after chopping, alone or in combination with BGs.
Several studies demonstrate that PRF is effective in promoting bone regeneration (BR) when used alone or in combination with BG during oral/ periodontal surgery.
To date, there are very few published clinical controlled trials that compare the results of PRF + BGs to the outcomes of PRF / BG alone in the treatment of IBDs and no study about PRF + ABG in the same defects. Only one case report tested the use of PRF + ABG mixed with bovine hydroxyapatite in the treatment of insufficient alveolar ridge width in aesthetic area. The aim of the present study is to verify if the combined use of PRF + ABG in the management of IBDs may be a treatment modality clinically "not inferior" to that with EMD + ABG.
详细描述
Experimental Design. This is a prospective, randomized and controlled clinical trial designed to evaluate the clinical and radiographic outcomes 12 months after two treatment modalities of IBDs: PRF + ABG into defects in the test subjects( TS); EMD + ABG in the control subjects ( CS). The patients enrolled exhibit unfavourable IBDs and all experimental sites will be accessed with a simplified papilla preservation flap ( SPPF) procedure. The filling material (ABG) is common to both treatments: therefore, the investigation will focus on the addictive effect of PRF used in place of EMD. EMD is chosen as the active control ( AC) as it is currently considered as the biological "gold standard" agent for the treatment of IBDs.
A non-inferiority trial ( NIT) is designed to prove that using PRF instead of EMD could achieve a similar result, reducing the treatment's cost and allowing the clinicians to use autogenous material only.
An AC (comparator) is present, but the investigators do not include a third experimental arm, a group of IBDs treated using Open Flap Debridement ( OFD) alone, as it is widely accepted in NITs.
The estimate of the AC effect vs. placebo is assumed from a recent meta-analysis, by the Lower Bound of a 95% Confidence Interval ( CI) of the mean of EMD + ABG, while an OFD estimate from the corresponding 95% CI Lower Bound is adopted by Venezia (2004). The difference between estimates is set as the added benefit of the AC and as a ground for the assay sensitivity.
Study Population. 44 patients affected by moderate-to-severe chronic periodontitis, will be selected for the study. Each patient will participate in the study with a single experimental site. The participants will receive verbal and written information and they 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, revised in Tokyo in 2004. Four months before the surgical treatment, all 44 patients will undergo SRP by ultrasonic instruments and hand curettes and motivational instructions on oral home care.
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 65 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) 25 and a full-mouth bleeding score (FMBS) 26 < 20% at the time of surgery
- •to have at least 20 teeth,; at least 1 tooth exhibiting vertical bone loss detected by radiographic examination (alveolar crest level [ ACL] - bottom of the defect [ BD] distance = Bone defect depth [ BDD]) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after phase I non- surgical therapy [ scaling and root planing ( SRP)].
排除标准
- •no systemic diseases
- •no medications affecting periodontal status during the previous 6 months
- •not pregnant or lactating; non-smoker
- •and no periodontal therapy in the 2 previous years, no inadequate endodontic treatment, no dental mobility,
研究组 & 干预措施
EMD treated patients
Periodontal surgery with Enamel Matrix Derivative is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers EMD will be applied to the entire root surfaces ; then, ABG will be applied alternatively with EMD into the IBD according to the "sandwich" technique until the IBD will be completely filled. Finally the flap will be repositionated and sutures completed by interrupted sutures.
干预措施: Periodontal surgery with Enamel Matrix Derivative (Procedure)
PRF treated patients
Periodontal surgery with Platelet Rich Fibrin is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous corticocancellous BG material will be collected using bone scrapers , the PRF membrane cut into small pieces and mixed with the ABG will be placed within the IBDs until they will be completely filled. Then the other two PRF membranes in each patient will be adapted over the grafted defect Finally horizontal mattress and interrupted sutures will be carried out.
干预措施: Periodontal surgery with Platlet Rich fibrin (Procedure)
结局指标
主要结局
Periodontal attachment gain
时间窗: 1 year
Reduction of the distance between the cementum-enamel junction and the depth of the probable site
次要结局
- Bone gain(1 year)
研究者
Michele Paolantonio
professor and chairman
G. d'Annunzio University