Evaluation of Bone Dimensional Changes After Using Xenograft with or Without Erythropoietin Around Immediate Implants in the Esthetic Zone: a Randomized 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
- Buccal bone thickness.
研究概览
简要总结
The aim of this study is to evaluate changes in buccal bone thickness after immediate implant placement with xenograft mixed with erythropoietin in the anterior maxilla with a thin buccal bone
详细描述
PICO:
Population: Patients with non-restorable tooth in anterior maxilla with thin buccal bone (less than 1mm) Intervention: Immediate implant placement with Xenograft mixed with Erythropoietin.
Control: Immediate implant placement with Xenograft alone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria
- •Adult (≥18 years) with non-restorable maxillary teeth in the esthetic zone (upper right second premolar to upper left second premolar).
- •Intact with thin labial plate of bone (≤1mm).
- •The recipient site of the implant should be free from any pathological conditions.
- •Patients who are cooperative, motivated and hygiene conscious.
- •Appropriate crown height space to maintain favorable crown : implant ratio
排除标准
- •Systemic conditions/diseases that contraindicate surgery.
- •Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- •Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
- •Patients with periodontal disease.
- •Alcohol or drug abuse.
- •Pregnant and lactating women.
研究组 & 干预措施
Group A (Test)
Immediate implant placement with Xenograft mixed with Erythropoietin
干预措施: Erythropoietin (EPO) with xenograft (Combination Product)
Group B (Control)
Immediate implant placement with Xenograft alone
干预措施: Xenograft alone (Other)
结局指标
主要结局
Buccal bone thickness.
时间窗: 1 year follow up period
by Cone Beam Computed Tomography (CBCT) in mm
次要结局
- Full-mouth plaque score(1 year follow up period)
- Crestal bone loss(1 year follow up period)
- Soft tissue thickness.(1 year follow up period)
- The pink esthetic score (PES)(1 year follow up period)
- Success and survival criteria(1 year follow up period)
- Bleeding on probing (BOP)(1 year follow up period)
- Pain score(1, 3, and 7 days)
研究者
Kholoud Sobhy Ibrahim Farag El Deeb
assistant lecturer at future university in egypt
Cairo University