Soft Tissue Augmentation by Xenogenic Collagen Matrix Versus Sub Epithelial Connective Tissue Graft Around Early Implant Placement in Maxillary Esthetic Zone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Peri-implant soft tissue thickness
研究概览
简要总结
This study compares two methods used to improve gingival tissue around dental implants placed in (the maxillary esthetic zone). After a tooth is removed and a dental implant is placed early (usually 4-8 weeks later), additional soft tissue is sometimes needed to ensure the implant looks natural and functions well. The two techniques being studied are:
Subepithelial connective tissue graft (SCTG) - where tissue is taken from the patient's own mouth (usually the palate)
Xenogeneic collagen matrix (XCM) - a processed collagen material from animals, used as a substitute for the patient's own tissue.
The goal is to see which method is better in terms of gingival thickness, esthetic appearance, healing, and patient comfort. This research may help dentists choose the most effective and comfortable treatment for their patients.
详细描述
Dental implants in the anterior maxillary region (esthetic zone) are commonly used to replace missing teeth. When implants are placed using the early placement protocol (typically 4-8 weeks after tooth extraction), additional soft tissue volume may be required to ensure an esthetically pleasing and functionally stable result.
Soft tissue augmentation can be achieved using:
Subepithelial connective tissue grafts (SCTG): A technique that involves harvesting tissue from the patient's own palate and placing it around the implant to improve gingival thickness and contour.
Xenogeneic collagen matrix (XCM): A biocompatible, animal-derived collagen scaffold designed to substitute for autologous tissue, reducing patient morbidity and surgical time.
This study is a prospective, randomized, controlled, parallel-arm clinical trial conducted at Minia University, Faculty of Dentistry. Eligible patients missing a single tooth in the anterior maxilla with a thin gingival biotype and requiring early implant placement were recruited. A total of 20 patients were randomly assigned into two groups (10 per group):
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor responsible for evaluating soft tissue volume and esthetic results is blinded to the group allocation to reduce assessment bias. Participants and care providers are not blinded due to the nature of the surgical interventions.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Inclusion Criteria:**
- •Non-restorable or hopeless teeth from maxillary anterior to first premolar due to one or more of the following:
- •Extensive caries
- •Root fractures
- •Inability to perform functional crown lengthening due to gingival zenith line with high gingival display
- •Improper crown-to-root ratio due to bone removal leading to aesthetic or restorative failure
- •Patients aged 25-55 years
- •Both male and female patients
- •Thin tissue biotype
排除标准
- •Pregnant women
- •Presence of persistent chronic infection at the implant site
- •Patients in the growth phase with partially erupted teeth
- •Patients with parafunctional habits such as bruxism or clenching that may overload the implant
- •Patients with insufficient vertical inter-arch space in centric occlusion to accommodate restorative components
结局指标
主要结局
Peri-implant soft tissue thickness
时间窗: 12 months after implant placement
change in soft tissue thickness measured in millimeters at the buccal aspect of the implant site.
次要结局
未报告次要终点
研究者
Mohamed Omar ismail phd
PhD Candidate, Faculty of Dentistry
Minia University