Assessment of Hard and Soft Tissue Changes Following Xenogeneic Collagen Membrane Versus Free Gingival Graft Simultaneous With Delayed Dental Implant Placement: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Keratinized tissue width
研究概览
简要总结
Teeth loss are usually associated with alterations of extraction sockets result in obviously absorbed alveolar ridges and are often accompanied with soft tissue atrophy such as narrow keratinized tissue and a shallow vestibule.
Lack of peri-implant keratinized tissue is a potential risk to peri-implant diseases. Although the role of width of KM in maintaining peri-implant health is a controversial topic, the majority of high-level evidence has suggested that a minimum KM width (KMW) of 2 mm around the dental implants is critical to maintain peri-implant health and the long-term survival of dental implants.
详细描述
This study will be carried out on patients attending outpatient clinic of Oral maxillofacial surgery and Periodontology Departments, Faculty of Dentistry. Modern University for Technology and Information, Cairo, Egypt.
P: Healthy patients with posterior missing teeth with deficient keratinized tissue to receive delayed dental implant placement I: Xenogeneic collagen membrane (XCM) simultaneous with delayed implant placement C: Free gingival graft (FGG) simultaneous with delayed implant placement O: Keratinized tissue width (KMW), graft shrinkage (GS), marginal bone loss (MBL) T- One year S- Randomized controlled clinical trial.
Eligible patients will be divided into equal proportions between control group and test group.
The control group "Group 1" will receive FGG simultaneous with implant placement The test group "Group 2" will receive XCM simultaneous with implant placement
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults above the age of 18 years.
- •Presence of 2mm or less of keratinized tissue width
- •Sufficient alveolar ridge width minimum of 6 mm
- •Patients with good oral hygiene as evidenced by plaque index (PI)<1 and showing cooperation or compliance with treatment.
排除标准
- •Patients diagnosed with periodontal diseases (Caton et al., 2018).
- •Acute active infection at implant sites
- •Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous bisphosphonates for treatment of osteoporosis and radiotherapy
- •Patients with parafunctional habits.
- •Smokers (≥10 cigarettes per day),
研究组 & 干预措施
Xenogeneic collagen matrix simultaneous with delayed implant placement
Tissue punch technique implants will be placed. XCM grafts (of bovine origin) will be trimmed to the required dimensions and will be fixed to the periosteum and sutured to the buccal peri-implant mucosa
干预措施: Xenogeneic collagen matrix simultaneous with delayed implant placement (Procedure)
Free gingival graft simultaneous with delayed implant placement
Tissue punch technique implants will be placed. A FGG will be harvested from the palate then the outlined graft will be placed and sutured to the recipient bed of the buccal peri-implant mucosa
干预措施: Free gingival graft simultaneous with delayed implant placement (Procedure)
结局指标
主要结局
Keratinized tissue width
时间窗: One year
mm
graft shrinkage
时间窗: One year
precentage
marginal bone loss
时间窗: One year
mm
次要结局
未报告次要终点
研究者
Parryhan Mohamed Abdelsamie
Lecturer of periodontology
MTI University