Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis. A Study of Peri-implant Tissue Changes and Prosthetic Complications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Marginal bone level change
研究概览
简要总结
This clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses. Ten completely edentulous patients are randomly allocated into two equal groups. The study evaluates peri-implant soft tissue health, changes in marginal bone levels,and prosthetic complications over an 12-month follow-up period.
详细描述
Completely edentulous patients receive four mandibular implants according to the All-on-4 concept, with two anterior axial implants and two posterior tilted implants placed anterior to the mental foramina. Patients are randomly allocated to receive either a CAD/CAM-milled titanium framework or a nano-carbon fiber-reinforced framework. Clinical follow-up includes assessment of modified plaque index, modified gingival index, probing depth, and bleeding index. Marginal bone level changes are assessed radiographically at 6 and 12 months after insertion of the fixed prosthesis. Prosthetic complications are also evaluated.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Completely edentulous patients requiring mandibular implant-supported rehabilitation.
- •Adequate bone quantity and quality in the mandibular interforaminal region for implant placement.
- •Adequate restorative space for an implant-supported hybrid prosthesis.
- •Healthy oral mucosa and acceptable oral hygiene.
- •Patients medically fit to undergo implant surgery.
- •Ability and willingness to attend the scheduled follow-up visits and provide informed consent.
排除标准
- •Systemic conditions or medical contraindications that could interfere with implant surgery or healing.
- •History of radiotherapy to the head and neck region.
- •Alcohol abuse.
- •Bruxism or clenching habits.
- •Any local condition that could compromise implant placement or the planned prosthetic rehabilitation.
研究组 & 干预措施
Titanium Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a CAD/CAM-milled titanium framework.
干预措施: Titanium CAD/CAM Framework (Device)
Nano-Carbon Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a Nano-carbon fiber-reinforced CAD/CAM framework.
干预措施: Nano-Carbon CAD/CAM Framework (Device)
结局指标
主要结局
Marginal bone level change
时间窗: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
Radiographic assessment of changes in peri-implant marginal bone level around the implants in the titanium and nano-carbon framework groups.
次要结局
- Modified plaque index(At prosthesis insertion (T0), 6 months (T6), and 12 months (T12))
- Modified gingival index(At prosthesis insertion (T0), 6 months (T6), and 12 months (T12))
- Probing depth(At prosthesis insertion (T0), 6 months (T6), and 12 months (T12))
- Bleeding index(At prosthesis insertion (T0), 6 months (T6), and 12 months (T12))
- prosthetic complications(up to12 months after prosthesis insertion)
研究者
Ahmed Farouk Abdelwahed Saleh
PhD candidate in prosthodontics
Mansoura University