Comparison of Flapless Immediate Implant Placement With Titanium Mesh Versus Immediate Implants Placement With Collagen Membrane in Type II Socket: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Buccal bone thickness
研究概览
简要总结
Statement of the problem: Immediate implant placement is faced with several problems. One of the most important issues is dealing with defects in the buccal plate of bone in the esthetic zone.
Aim: The aim of this study is to assess the buccal bone thickness after augmentation with titanium mesh and xenograft upon flapless immediate implant placement.
详细描述
Statement of the problem: Immediate implant placement is faced with several problems. One of the most important issues is dealing with defects in the buccal plate of bone in the esthetic zone.
Aim: The aim of this study is to assess the buccal bone thickness after augmentation with titanium mesh and xenograft upon flapless immediate implant placement.
Materials and Methods
This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the anterior region and buccal bone deficiency requiring implant placement. They will be randomly allocated to two equal groups. Group A (test group, n=10) will receive immediate implants (grafting with xenograft covered by titanium mesh covered by collagen membrane), while group B (test group, n=10) will receive immediate implants (grafting with xenograft covered by collagen membrane). The parameters ( buccal bone thickness & soft tissue thickness will be assessed at 6 & 12 months. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
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)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have at least one remaining root or badly decayed tooth in anterior maxilla.
- •Systemically free patients (American Society of Anesthesiologists I; ASA I)
- •Patients aged from 21 to 50 years old
- •Buccal bone partial deficiency (extraction socket type II)
- •Good oral hygiene
- •Accepts the follow-up period (cooperative patients)
- •Patient accepts to provides an informed consent
排除标准
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits such as bruxism
- •Pregnant and lactating females
研究组 & 干预措施
immediate implant with collagen membrane
immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and collagen membrane
干预措施: collagen membrane (Procedure)
immediate implant with titanium mesh
immediate implant placement will be done and augmentation of the buccal bone will be done with xenograft and titanium mesh
干预措施: titanium mesh (Procedure)
结局指标
主要结局
Buccal bone thickness
时间窗: at baseline, 6 and 12 months
assessment of the Buccal bone thickness in mm using CBCT
次要结局
- Soft tissue thickness(at baseline 6 and 12 months)
- Keratinized tissue width(at baseline, 6 and 12 months)