Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
研究概览
简要总结
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned. The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed. In the first group, a free connective tissue graft with an epithelial collar will be used. In the second group, a free connective tissue graft without an epithelial collar will be used. In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
详细描述
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent for participation in the study;
- •Age between 18 and 45 years;
- •Bounded edentulous defects of the upper or lower jaw involving 1-2 teeth combined with soft tissue thickness deficiency around dental implants (<2 mm);
- •Teeth without periodontal pathology, with probing depth not exceeding 3 mm throughout the gingival sulcus;
- •Satisfactory level of oral hygiene;
- •Absence of systemic diseases in the stage of exacerbation or decompensation.
- •Non-inclusion criteria:
- •Patients who previously underwent connective tissue graft harvesting from the same donor site;
- •Patients with impacted third molars in the donor site area;
- •Presence of concomitant diseases in the stage of exacerbation or decompensation;
- •Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
- •Patients with a smoking history of more than 10 years.
排除标准
- •Patient refusal to continue participation in the study;
- •Pregnant or breastfeeding women;
- •Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
- •Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).