Prefabricated CAD/CAM Zirconia Membrane Versus Contour Augmentation Simultaneously With Dental Implant Placement in the Anterior Esthetic Area.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge
研究概览
简要总结
This clinical trial aims to compare two guided bone regeneration (GBR) techniques in patients with horizontal ridge deficiency in the anterior esthetic region. Specifically, it evaluates the use of a prefabricated CAD/CAM zirconia membrane versus conventional contour augmentation performed simultaneously with dental implant placement. The study includes male and female patients aged 20 to 50 years who are in good general health, maintain adequate oral hygiene, and present with a Class I ridge defect as per Seibert's classification.
The primary objective is to determine whether the customized zirconia membrane provides equivalent clinical and radiographic outcomes in terms of bone gain and soft tissue healing compared to the contour augmentation technique. Participants will also report their postoperative discomfort and overall satisfaction using a 100-point visual analog scale (VAS), recorded at multiple time points: 1, 6, and 12 hours, as well as 1, 3, 7, and 15 days postoperatively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders within the age range of 20-50 years.
- •Patients with good general health and adequate oral hygiene practices.
- •Stable periodontal condition and favorable soft tissue profile.
- •Alveolar ridge that has a Class I defect according to Seibert's classification of ridge defects.
排除标准
- •Patients with medical conditions or systemic diseases precluding periodontal surgery or hampering wound healing (e.g., uncontrolled diabetes mellitus or metabolic bone disorders).
- •Patients subjected to irradiation in the head and neck area.
- •Patients with a history of taking any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
- •Patients have poor oral hygiene and motivation.
- •Patients with active periodontitis or acute infection in the area intended for implant placement.
- •Females who are pregnant or trying to conceive, and nursing mothers.
研究组 & 干预措施
CAD/CAM Zirconia Membrane Group
Participants in this group will undergo guided bone regeneration using a customized, prefabricated CAD/CAM zirconia membrane designed based on the individual's ridge defect morphology. This membrane will be used in combination with particulate bone graft material and placed simultaneously with the dental implant in the anterior maxilla.
干预措施: CAD/CAM Zirconia Membrane (Device)
Contour Augmentation Group
Participants in this group will undergo conventional guided bone regeneration using particulate bone graft material covered with a resorbable collagen membrane. The grafting procedure will be performed simultaneously with dental implant placement in the anterior maxilla.
干预措施: Contour Augmentation (Procedure)
结局指标
主要结局
Alveolar bone gain in millimetres (mm) in the edentulous alveolar ridge
时间窗: Six months
Assessment of the horizontal and vertical bone gain in millimetres (mm) in the edentulous alveolar ridge from baseline (implant placement and grafting) to six months after surgery.
次要结局
- Periodontal Soft Tissue Healing (Modified Wound Healing Index - MWHI)(Baseline (day of surgery), and postoperatively at 4, 8, 12, and 24 weeks)
- Patient-Reported Postoperative Discomfort and Satisfaction(1 hour, 6 hours, 12 hours, and 1, 3, 7, 15 days postoperatively)
- Membrane-Related Operative Time(Recorded during the implant placement and bone regeneration surgery)
研究者
Mohammed Mashhout Eisa Anas
Dentist
Tanta University