IMMEDIATE IMPLANTOLOGY: EFFECTS OF BONE GRAFTING ON MANDIBULAR BONE MICROSTRUCTURE USING FRACTAL ANALYSIS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE
研究概览
简要总结
This prospective, randomized, controlled, split-mouth clinical trial aims to evaluate the effect of bone grafting on mandibular bone microstructure following immediate implant placement using fractal analysis of panoramic radiographs. Forty systemically healthy adults requiring bilateral immediate implant placement in the mandibular anterior region will be enrolled. In each participant, one implant site will receive a bone graft (Gen-Os), while the contralateral site will serve as the non-grafted control. Panoramic radiographs obtained during routine postoperative follow-up at 1 and 3 months will be analyzed using ImageJ software to calculate fractal dimension values. The primary outcome is the comparison of fractal dimension values between grafted and non-grafted implant sites. The results are expected to provide evidence regarding the effect of bone grafting on early bone healing and microstructural changes following immediate implant placement.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 40 years. Requiring bilateral immediate implant placement in the mandibular anterior region.
- •Indication for tooth extraction in the mandibular anterior region. Systemically healthy (ASA I). Adequate bone volume for immediate implant placement. Willing and able to attend the scheduled follow-up visits. Routine panoramic radiographs suitable for fractal analysis. Provided written informed consent.
排除标准
- •Age younger than 18 years or older than 40 years. Systemic diseases affecting bone metabolism. Uncontrolled diabetes mellitus, osteoporosis, or other metabolic bone disorders.
- •Current use of bisphosphonates, corticosteroids, immunosuppressive drugs, or other medications affecting bone healing.
- •Pregnancy or breastfeeding. Active infection at the implant site. Heavy smoking or tobacco use. Previous radiotherapy to the head and neck region. Inadequate bone volume preventing immediate implant placement. Inability to attend follow-up visits. Refusal or inability to provide written informed consent.
研究组 & 干预措施
BONE GRAFT GROUP
IMMEDIATE IMPLANT SITES RECEIVING GEN-OS BONE GRAFT MATERIAL FOLLOWING TOOTH EXTRACTION. BONE HEALING WILL BE EVALUATED USING FRACTAL ANALYSIS OF ROUTINE PANORAMIC RADIOGRAPHS OBTAINED AT 1 AND 3 MONTHS.
干预措施: BONE GRAFTING (Procedure)
NO BONE GRAFT GROUP
IMMEDIATE IMPLANT SITES WITHOUT BONE GRAFTING FOLLOWING TOOTH EXTRACTION. BONE HEALING WILL BE EVALUATED USING FRACTAL ANALYSIS OF ROUTINE PANORAMIC RADIOGRAPHS OBTAINED AT 1 AND 3 MONTHS.
干预措施: NO BONE GRAFT (Other)
结局指标
主要结局
FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE
时间窗: 1 month after immediate implant placement and 3 months after immediate implant placement
Fractal dimension values of the peri-implant bone will be measured on digital panoramic radiographs using ImageJ software. Fractal dimension is a unitless numerical parameter used to assess trabecular bone microstructure. Higher values indicate greater trabecular complexity.
次要结局
- CHANGE IN FRACTAL DIMENSION VALUE MEASURED USING IMAGEJ SOFTWARE(1 month and 3 months after immediate implant placement)
研究者
sema kaya
ASSISTANT PROFESSOR, DEPARTMENT OF ORAL AND MAXILLOFACIAL RADIOLOGY
Yuzuncu Yil University