Periodontal Regeneration in Non-contained Intrabony Defects Using Autologous Micrografts From the Palatal Mucosa: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Clinical attachment level change
研究概览
简要总结
Some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. The primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic scaffold for periodontal regeneration of intrabony defects in terms of clinical attachment level gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill) compared to a scaffold alone. Moreover, this study aims to compare early wound healing and patient-reported outcome measures between the two groups.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients selected for the study should fulfil the following inclusion criteria:
- •Affected from stage III-IV periodontitis.
- •Completed non-surgical periodontal therapy.
- •FMPS <15% at 3-month re-evaluation.
- •FMBS <15% at 3-month re-evaluation.
- •At least one site with an interproximal intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, extending to the lingual/palatal side as assessed by preoperative bone sounding.
- •Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion), requiring flap elevation on both buccal and oral side for its accessibility.
- •Signed informed consent.
排除标准
- •Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- •Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulatory drugs (e.g., cyclosporine), and high-dose oral contraceptives.
- •Current smokers (self-reported), users of chewing tobacco, and drug/alcohol abusers.
- •Pregnant or nursing women.
- •Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
- •Very large and wide defects that required the use of membrane.
结局指标
主要结局
Clinical attachment level change
时间窗: 12 months
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
次要结局
- Radiographic bone level change(12 months)
- Probing pocket depth change(12 months)
- Patient reported outcome measures(2 weeks)
研究者
Mario Aimetti
Associate Professor
University of Turin, Italy