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临床试验/NCT07272694
NCT07272694
已完成
不适用

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

Vladimir Biocanin1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年3月13日最近更新:

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

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

发起方
Vladimir Biocanin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vladimir Biocanin

Principal Investigator

Faculty of Stomatology in Pancevo

研究点 (1)

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