Accuracy Assessment of Symphyseal Onlay Bone Grafting for 3D Maxillary Ridge Augmentation Using Tooth-supported Patient-specific Surgical Guide Versus Free Hand Technique: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Alveolar ridge width bone gain
研究概览
简要总结
This study compares the accuracy of osteotomies positions using patient specific guides for onlay bone shells harvested from the chin then the graft positioning for 3D upper anterior ridge augmentation using patient-specific tooth-supported guide versus free hand technique
详细描述
In this study the tooth-supported stereolithographic guiding template is proposed to allow accurate onlay grafting of labial and palatal mono-cortical shells simultaneously after harvesting using computer-designed patient-specific surgical osteotomy guide. This customized osteotomy guide should provide accurate harvesting of autogenous bone blocks from chin area which also provides suitable contour with the anterior ridge area. This computer assisted surgery is supposed to help in decreasing the operation time, thus decreasing the devascularization time to the bone graft. Thus, it helps for increased accuracy to increase three-dimensional bone gain and decrease morbidity of donor site while gaining the maximum available bone volume. Tooth-supported graft placement guide provides reproducible and convenient design without the need of high surgical skills as well.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Anterior maxilla with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually, combined with vertical deficiency.
- •Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- •Both genders males and females will be included
- •Normal vertical dimension with normal inter-arch space
排除标准
- •Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
- •General contraindications to implant surgery.
- •Subjected to irradiation in the head and neck area less than 1 year before implantation.
- •Untreated periodontitis.
- •Poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnant or nursing females.
- •Immunosuppressed or immunocompromised
- •Heavy smokers
- •Patients undergo medication interfere with bone healing
研究组 & 干预措施
Tooth-supported Patient-specific Surgical Guide
In this study computer-designed patient-specific surgical osteotomy guide provides accurate harvesting of autogenous bone blocks from chin area.Then, graft placement will be done using patient-specific tooth-supported guide in upper anterior deficient ridge and fixation using 2 micro screws labially and one through and through for the palatal shell.
干预措施: 3D ridge augmentation using tooth-supported patient-specific guide (Procedure)
Free hand technique
The cortical bone harvested from chin area without surgical guide, then the non-guided mono-cortical bone block grafting will be fixed on the ridge labially using 2 micro screws and one through and through for the palatal shell.
干预措施: 3D ridge augmentation using tooth-supported patient-specific guide (Procedure)
结局指标
主要结局
Alveolar ridge width bone gain
时间窗: 4 months
measures will be obtained from CT scan in millimetres
次要结局
- Alveolar ridge vertical bone gain(4 months)
研究者
Wesam Sami Hassan Ali
Resident at oral and maxillofacial surgery department
Cairo University