Transforming Channel Shape Osteotomy Into Tunnel Shape Osteotomy for Zygomatic Implant. A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1-soft tissue thickness 2-Soft tissue recession
研究概览
简要总结
The evolution of zygomatic implant techniques, from the original procedures to the Zygomatic Anatomy-Guided Approach (ZAGA), has significantly improved outcomes for patients with severe maxillary atrophy. Despite these advancements, challenges such as peri-implant tissue recession, sinus complications, and aesthetic concerns persist. Bone augmentation and soft tissue enhancement techniques, including sinus lifts, connective tissue grafts, and buccal fat pad utilization, have been employed to address these issues with varying degrees of success. However, the need for predictable and stable bone regeneration and soft tissue contouring remains critical for long-term implant success.
The following study aims to assess bone gain, soft tissue contour, and stability after using bone lamina shell, providing a potential solution to enhance peri-implant tissue integrity and optimize functional and aesthetic outcomes in zygomatic implant rehabilitation
详细描述
The term "tunnel osteotomy" is used because the alveolar osseous entry point has a floor, lateral walls, and a more or less complete roof. When a tunnel osteotomy was chosen, the sinus membrane was perforated at the time of completion of the antrostomy. The objective was to achieve osseointegration at the neck level also to seal the sinus entrance in the long-term using: (1) a stable zygomatic implant with (2) a suitable threaded neck section (3) bordered by enough bone at the coronal entry, (4) stabilized by adequate apical zygomatic anchorage; and (5) connected to a rigid prosthesis that provides adequate masticatory load distribution. The "tunnel osteotomy" was also employed in ZAGA Type 3 cases when the alveolar bone adopts a triangular, buccally inclined, profile and the maxillary anterior wall was concave(23).
When inadequate residual bone architecture at the crestal level (less than 4 mm of thickness) was measured, the coronal osteotomy was buccally shifted to prevent future sinus or nasal-oral communication/fistula. Implant beds were designed to be carved as much as possible into both the buccal alveolar and maxillary wall bone with the limits of sinus lining integrity. This osteotomy type is known as a "channel osteotomy" and is noted when lateral walls and floor are present but with no roof(23).
On analyzing the evolution of the abovementioned technique (ZAGA), it is seen that the position of the neck of the zygomatic implants has been mobilized laterally from an intrasinus position to an extrasinus position. Different anterior techniques have thus sought to avoid maxillary sinus complications(19,24,25). However, hard and soft tissue infective and aesthetic complications (exposure of the implant threads) were detected(26-28).
Peri-implant hard and soft tissues are crucial for avoiding complications around conventional implants. Two aspects have been studied in this regard: buccal cortical bone and the thickness and width of the peri-implant keratinized mucosa. On the one hand, a recent systematic review has reported that a buccal cortical thickness of close to 2 mm was associated with less vertical bone resorption and less mucosal recession(29).
On the other hand, the presence of sufficient keratinized mucosa thickness exerts a protective effect against marginal bone loss(30,31). These abovementioned concepts to minimum necessary peri-implant tissues could be extrapolated to zygomatic implants. A number of techniques for bone and soft tissue enhancement around zygomatic implants have been described, with high success rates.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 -Patients older than 21 years.
- •Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 5mm in height, in the area immediately distal to the canine pillar)
- •Patients with at least more than half of the zygomatic implant platform diameter inside the alveolar bone crest.
排除标准
- •1 - Patients with systemic conditions contra-indicating general anesthesia.
- •Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
- •3. Patients with acute maxillary sinus infection or maxillary sinus cyst.
- •Restricted mouth opening (less than 3cm inter-arch distance anteriorly).
研究组 & 干预措施
group A
Zygomatic implants placed in Channel shape osteotomy with using xenogenic malleable bone shell to convert osteotomy type to tunnel osteotomy.
干预措施: Group A (Procedure)
group B
Zygomatic implants placed in Channel shape osteotomy with only soft tissue augmentation by using buccal bad of fat.
干预措施: Group B (Procedure)
结局指标
主要结局
1-soft tissue thickness 2-Soft tissue recession
时间窗: 6 months of healing
For soft tissue recession, a clinical visual exploration was performed, and defects were measured through a periodontal probe from fixed reference point (buccal surface of implant platform). For soft tissue thickness, a clinical method by using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe
次要结局
- Bone gain(6 months of healing)
研究者
haitham ahmed mohammed elmaergy
doctor
Fayoum University
