Evaluation of the Carrot Technique With Simultaneous Implant Placement for Horizontal Alveolar Ridge Deficiency in the Maxillary Aesthetic Zone: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Alveolar Ridge Width
研究概览
简要总结
This randomized controlled clinical trial aims to compare the effectiveness of the Carrot Technique and Guided Bone Regeneration (GBR) for the management of horizontal alveolar ridge deficiency in patients requiring implant placement in the maxillary esthetic zone. Twenty patients will be randomly allocated into two equal groups. Clinical outcomes including implant stability and soft tissue healing, as well as radiographic outcomes including alveolar ridge width, bone density, and marginal bone loss, will be evaluated using clinical examinations and cone beam computed tomography (CBCT) during a 12-month follow-up period..
详细描述
The Carrot Technique is a minimally invasive approach that utilizes an autogenous bone core harvested during implant osteotomy and repositioned to augment the deficient buccal ridge. This technique may reduce donor-site morbidity while providing sufficient horizontal bone augmentation. Guided Bone Regeneration remains one of the most widely used techniques for horizontal ridge reconstruction through the use of bone substitute materials and barrier membranes.
This randomized controlled clinical trial will compare the clinical and radiographic outcomes of the Carrot Technique and GBR in patients presenting with horizontal ridge deficiency in the maxillary esthetic zone. Twenty patients requiring single-tooth implant rehabilitation will be randomly allocated into two equal groups. Group I will receive implant placement combined with the Carrot Technique, while Group II will receive implant placement combined with Guided Bone Regeneration.
Clinical evaluations will include implant stability assessed by resonance frequency analysis, soft tissue healing using the Landry Healing Index, and peri-implant inflammation using the modified sulcus bleeding index. Radiographic evaluation will be performed using cone beam computed tomography immediately after surgery and at 6 and 12 months postoperatively to assess changes in alveolar ridge width, bone density, and marginal bone loss. The study aims to determine whether the Carrot Technique provides comparable or superior outcomes to GBR for horizontal ridge augmentation associated with 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 45 years. Missing a single tooth in the maxillary esthetic zone requiring implant placement.
- •Good oral hygiene and patient compliance. Medically free from systemic diseases that contraindicate implant surgery. Slight to moderate horizontal alveolar ridge deficiency with a minimum ridge width of 5 mm.
- •Adequate vertical bone height for implant placement. Medium to hard bone quality (D2-D3 according to Misch classification). Absence of bruxism or other parafunctional habits.
排除标准
- •Presence of local pathological lesions (e.g., cysts or tumors) at the planned surgical site.
- •Poor bone quality (D4 bone). Pregnancy. Heavy smoking. Any medical condition contraindicating implant surgery.
结局指标
主要结局
Change in Alveolar Ridge Width
时间窗: baseline and 12 Months
Horizontal alveolar ridge width measured using cone beam computed tomography (CBCT). Changes in ridge width will be calculated by comparing measurements obtained immediately after surgery and at follow-up.
次要结局
- Marginal Bone Loss(12 Months)
- Soft Tissue Healing(1 Week, 2 Weeks, and 1 Month)
- Modified Sulcus Bleeding Index(1 Month and 12 Months)
- Bone Density(12 Months)
- Implant Stability Quotient (ISQ)(At implant placement and 12 months)