Peri Implant Soft Tissue Healing in Single Implant Restoration Using the Guided Bone Regeneration Technique Ore a Connective Tissue Graft
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- change from baseline in the clinical characteristics of the peri implant mucosa
研究概览
简要总结
The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance the stability of peri implant soft tissue, when compared to the grafting technique ( bilaminar technique), performed in association with implant placement .
详细描述
With respect to the soft tissue management many surgical approaches have been described in order to increase soft tissue volume and keratinized tissue height at implant site: roll flaps, connective tissue graft , epithelial connective tissue graft. In recent years, soft tissue substitutes , such as acellular dermal matrix or collagen matrix have been proposed to increase the dimensions of peri implant soft tissues; however, further studies have demonstrated that the allograft materials were less effective and less predictable than autogenous soft tissue grafts, in terms of increasing attached keratinized tissue , due to the considerable shrinkage and inconsistent quality of the attached tissue gained ; consequently soft tissue graft from the palate are currently considered the gold standard for augmenting peri implant soft. Some clinical studies proposed the association of contour augmentation by guided bone regeneration (GBR) with implant placement. The aim of these procedures is to restore the missing volume and to establish a facial bone wall of sufficient height and thickness to serve as a support for peri implant soft tissues; in these terms, GBR could be considered important to increase the stability of peri implant soft tissue , preventing the marginal soft tissue shrinkage and the following exposition of implant . This could be a valid approach to stabilize coronal peri implant soft tissue and at the same time less traumatic than grafting procedures.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •one missing tooth in the anterior maxilla
- •facial keratinized mucosa thickness of at least 2mm
排除标准
- •heavy smokers
- •systemic diseases
研究组 & 干预措施
Bio-Oss®, Bio-Gide®
augmentation procedure with Bio-Oss® and Bio-Gide®
干预措施: augmentation procedure with Bio-Oss® and Bio-Gide® (Device)
connective tissue graft
augmentation procedure with connective tissue graft
干预措施: augmentation procedure with connective tissue graft (Procedure)
结局指标
主要结局
change from baseline in the clinical characteristics of the peri implant mucosa
时间窗: one month and one year after the placement of the definitive crowns
Buccal mucosa thickness was assessed with a calibrated endodontic file, 2 mm apical to the bone crest
次要结局
- Change from baseline in probing pocket depth recorded at both mesial and distal tooth , adjacent to the implant site, by means of a periodontal probe(one month and one year after the placement of the definitive crowns)
- change from baseline in height of keratinised tissue recorded at both mesial and distal tooth , adjacent to the implant site , by means of a periodontal probe(one month and one year after the placement of the definitive crowns)
研究者
nicola baldini
oral surgeon
University of Firenze and Siena, Napoli, Italy
