Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pink Esthetic Score (PES)
研究概览
简要总结
This randomized controlled study is aimed to evaluate the esthetic, clinical, and radiographic outcomes following the placement of immediate single-tooth implant with hard and soft tissue augmentation.
Subjects will randomly assigned to one of two groups:
- Group A (control group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation only.
- Group B (study group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation and connective tissue graft (CTG).
The main questions it aims to answer is:
Is there is a significant difference in the esthetic outcome between bone augmentation alone and bone augmentation combined with connective tissue graft after immediate dental implant in the esthetic zone?
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a non-restorable tooth or a remaining root without signs of acute infection in the maxillary esthetic zone.
- •The failing tooth is an incisor, canine or first bicuspid in the maxilla bounded by natural sound teeth.
- •Sufficient bone (>4 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥35 N cm).
- •Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
排除标准
- •Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
- •Teeth with current acute periapical infection.
- •Dehiscence of the labial (facial) bone plate after extraction.
- •Signs of uncontrolled periodontal disease.
- •Heavy smokers and vulnerable groups (pregnant females and decision-impaired individuals).
- •History of head and neck radiation therapy.
研究组 & 干预措施
Hard tissue augmentation with connective tissue graft
Hard tissue augmentation (bone grafting) with additional connective tissue graft (CTG) performed at the same time following immediate dental implant in the esthetic zone
干预措施: Immediate dental implant in the esthetic zone (Procedure)
Hard tissue augmentation
Hard tissue augmentation (bone grafting) following immediate dental implant in the esthetic zone.
干预措施: Immediate dental implant in the esthetic zone (Procedure)
结局指标
主要结局
Pink Esthetic Score (PES)
时间窗: Pink esthetic score (PES) will be assessed at 6 months postoperatively.
Seven variables to be scored: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process, soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter to obtain a final score of 14.
次要结局
- Patient satisfaction questionnaire(6 months postoperatively)
- Implant survival rate(6 months postoperatively)
- Rate of complications(From the intervention to 6 month postoperatively)
- Hard tissue assessment (facial bone thickness)(6 months postoperatively)
研究者
Khalid Walid Khalid
Principal Investigator
University of Baghdad