A Prospective Controlled Clinical Study Evaluating the Effect of Bone and Autologous Dentin Grafting in the Osteotomy Gap During the Split Crest Procedure With Simultaneous Implant Placement
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vladimir Biocanin
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in alveolar ridge width following split crest proceduree with or without bone or dentin grafting
概览
简要总结
This prospective controlled clinical study evaluates the effectiveness of adding bone graft or dentin graft material during the split crest (alveolar ridge splitting) procedure for horizontal ridge augmentation with simultaneous implant placement.
The study includes patients with narrow alveolar ridges requiring implant-supported rehabilitation. Participants are divided into three groups: split crest without grafting, split crest with bone graft, and split crest with dentin graft. The aim is to determine whether the addition of graft material to the osteotomy gap improves bone width, bone density, and primary implant stability compared to the split crest technique alone.
Clinical and radiographic assessments are performed using cone-beam computed tomography (CBCT) and implant stability measurements (ISQ values) before surgery, immediately after implant placement, and three months postoperatively. All patients are monitored over a one-year follow-up period to evaluate healing progression and treatment outcomes.
This study seeks to identify the most effective approach for horizontal ridge augmentation and to improve clinical decision-making in implant dentistry. The findings aim to contribute to optimizing surgical protocols, enhancing implant stability, and improving long-term functional outcomes for patients.
Participation is voluntary, and all procedures are conducted in accordance with approved ethical standards and clinical guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-65 years
- •Indication for tooth extraction in posterior mandibular region with planned implant placement
- •Presence of post-extraction alveolar bone defect requiring ridge preservation procedure
- •Good general health (ASA I or ASA II)
- •Ability to understand the study procedures and provide written informed consent
- •Willingness to comply with scheduled follow-up visits and study protocol
排除标准
- •Systemic diseases affecting bone healing (e.g. uncontrolled diabetes, osteoporosis, metabolic bone disorders)
- •History of radiotherapy in the head and neck region
- •Use of bisphosphonates or other antiresorptive medications
- •Active periodontal or periapical infection at the surgical site
- •Heavy smokers (\>10 cigarettes per day)
- •Pregnancy or breastfeeding
- •Known allergies to materials used in the study
- •Poor oral hygiene or lack of complianc
结局指标
主要结局
Change in alveolar ridge width following split crest proceduree with or without bone or dentin grafting
时间窗: Preoparative, Immediately postoperative, and 3 months after surgery
次要结局
未报告次要终点
研究者
Vladimir Biocanin
Principal Investigator
Faculty of Stomatology in Pancevo