Abstract:
Background: We have recently proposed an alternative strategy of free gingival graft (FGG) and connective tissue graft (CTG) using micronized-gingival connective tissues (MGCTs). The advantage of this strategy is that MGCTs from a small piece of maxillary tuberosity can regenerate the keratinized tissue band. However, safety and efficacy have not yet been established in patients. This clinical study was a pilot case series, and the objective was to assess the safety and the preliminary efficacy of MGCTs on peri-implant mucosa regeneration. Methods: This was a pilot interventional, single-center, first-in-human (FIH), open (no masking), uncontrolled, and single-assignment study. A total of 4 patients who needed peri-implant soft tissues reconstruction around dental implants received transplantation of atelocollagen-matrix with MGCTs micronized by the tissue disruptor technique. The duration of intervention was 4 weeks after surgery. Results: This first clinical study demonstrated that using MGCTs did not cause any irreversible adverse events, and it showed the preliminary efficacy for peri-implant soft tissues reconstruction in dental implant therapy. Conclusions: Though further studies are needed on an appropriate scale, as an alternative strategy of FGG or CTG, MGCTs might be promising for peri-implant mucosa reconstruction without requiring a high level of skills and morbidity to harvest graft tissues.
摘要:
背景:我们最近提出了一种使用微粉化牙龈结缔组织(MGCT)的游离牙龈移植物(FGG)和结缔组织移植物(CTG)的替代策略。该策略的优点是来自一小块上颌结节的MGCT可以再生角化组织带。然而,患者的安全性和有效性尚未确定.这项临床研究是一系列试点病例,目的是评估MGCTs对种植体周围粘膜再生的安全性和初步疗效。方法:这是一个试点介入,单中心,人类第一(FIH),打开(无掩蔽),不受控制,和单一作业学习。共有4例需要在牙种植体周围进行种植体周围软组织重建的患者接受了通过组织破坏器技术微粉化MGCTs的去端胶原-基质移植。干预时间为手术后4周。结果:第一项临床研究表明,使用MGCTs不会引起任何不可逆的不良事件,显示了种植体周围软组织重建在牙种植治疗中的初步疗效。结论:尽管需要在适当的规模上进行进一步的研究,作为FGG或CTG的替代策略,MGCT可能有希望用于植入物周围粘膜重建,而不需要高水平的技能和发病率来收获移植组织。