Comperative Clinical, Microcircular, Surface Scanning, Radiological and Histological Evaluation of Two Different Flap Techniques - A Prospective Randomized Clinical Trial/
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Orovestibular ridge width
研究概览
简要总结
The aim of the present prospective randomized controlled study is to compare the clinical, radiological, micro-circulation, and histology of a novel, semi-thick, and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation.
详细描述
The aim of our study was to compare the clinical, radiological, circulatory, and histological studies of a novel, split-thickness and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation surgeries. Flap formation was performed in the test group using the novel split-thickness surgical technique, and in the control group using the full-thickness mucoperostatial surgical technique. The novel split-thickness flap technique to be studied results in a predictable, closed healing based on our preliminary results, thus ensuring the conditions for successful augmentation. We primarily want to investigate what hard and soft tissue changes result from ridge augmentation with a novel split-thickness flap technique after 6 months, compared to a surgical technique based on full thick flap formation accepted as a standard procedure in the literature. Our secondary examination methods: examination of early wound healing and micro-circulation after augmentation interventions by LSCI method; histological evaluation at prosthetically designed implant positions.
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 (Participant, Outcomes Assessor)
盲法说明
Participants are not aware of the randomly assigned flap design. Independent examiners are not aware of patient allocation during analysis of clinical and radiographic data.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least one edentulous maxillary/mandibulary premolar or molar site with horizontal bone loss
- •full- mouth plaque and bleeding scores (FMPS and FMBS) <20%
- •good patient compliance (including willingness to participate in the follow-up procedures) signed informed consent-
排除标准
- •Active infectious diseases (HBV, HCV, HIV, TB, SARS CoV-2, etc.)
- •Current chemotherapy or radiotherapy
- •Radiation treatment of the former head and neck region (not older than 2 years)
- •Untreated insulin-dependent diabetes mellitus
- •Clinically significant osteoporosis or other systemic disease affecting bone metabolism
- •Clinically significant circulatory disorders such as decompensated cardiac failure
- •Haemodynamically significant heart failure or myocardial infarction within the last 3 months
- •Clinically significant coagulation disorder
- •Current or previous systemic corticosteroid therapy (not older than 2 months)
- •Current or previous systemic bisphosphonate therapy
- •Pregnant or breastfeeding mothers
- •Drug addiction, alcoholism
研究组 & 干预措施
Split-thickness group
Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.
干预措施: Split-thickness group (Procedure)
Full-thickness group
Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.
干预措施: Full-thickness group (Procedure)
结局指标
主要结局
Orovestibular ridge width
时间窗: 6 months postoperatively
On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken parallel to a reference base to determine the orovestibular width of the surgical area.
Dimensional change of keratinized Gingiva
时间窗: 6 months postoperatively
Pre-and postoperatively a surface scan is performed using a Planmeca Emerald intraroral scanner. The superimposition of the measurements was used to evaluate the soft tissue changes associated with the treatments in 3 dimension.
次要结局
- Histomorphometrical analysis(Following reentry 6 months after augmentation)
- Gingival blood flow measurement at the early wound healing phase(Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.)