Dynamic Navigation for Zygomatic Implant Rehabilitation: An Innovative Protocol Using an Intraoral Reference System and Evaluation of a New Zygomatic Implant Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Implant Success Rate of Zygomatic Fixtures
研究概览
简要总结
This clinical study aims to evaluate the effectiveness and safety of zygomatic implants placed using dynamic navigation technology. Specifically, it compares two types of zygomatic implants with different surface characteristics: one with a fully rough surface and another with a partially smooth (machined) surface near the gum line. The goal is to determine whether surface design affects surgical performance, healing, implant success, and patient outcomes. A total of 22 patients with severe upper jaw bone loss will receive both types of implants-one on each side of the upper jaw-in a randomized, split-mouth design. The study also evaluates pain, swelling, healing time, and patient quality of life over a 5-year follow-up period.
详细描述
This prospective, randomized, split-mouth clinical study investigates the use of dynamic navigation for the placement of zygomatic implants in patients with severely atrophic maxillae. The primary aim is to compare two different surface configurations of zygomatic implants: a fully rough surface versus a partially machined (smooth) coronal surface. Each of the 22 enrolled patients will receive both implant types-one per side-allowing for direct intra-patient comparison.
All surgeries are planned using three-dimensional imaging and performed with a dynamic navigation system (ImplaNav), calibrated for the longer drills required for zygomatic implant sites. The study evaluates surgical accuracy, implant stability, preparation time, postoperative pain and swelling, sinus membrane response, and long-term implant and prosthetic success. Patient quality of life is also monitored over a 5-year follow-up using standardized questionnaires and radiographic assessments.
This study aims to provide evidence on whether implant surface design influences clinical performance and healing outcomes in zygomatic implant rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring partial or full rehabilitation of the atrophic maxilla
- •Candidates for placement of at least one zygomatic implant per side (right and left), connected to at least one standard or zygomatic implant
- •Severe maxillary atrophy confirmed by CT scan, with insufficient bone for conventional implants or only sufficient bone for 2 frontal implants (minimum diameter 3.5 mm, length 8 mm)
- •Residual alveolar crest height ≤ 4 mm beneath the maxillary sinus
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- •General contraindications to oral surgery
- •History of radiation therapy to the head and neck exceeding 70 Gy
- •Compromised or suppressed immune system
- •Current or past use of intravenous bisphosphonates
- •Uncontrolled diabetes mellitus
- •Alcohol or drug dependency
- •Psychiatric disorders
- •Pregnancy or breastfeeding
- •Participation in other clinical trials
- •Inability to attend a 5-year follow-up
- •Limited mouth opening (< 3.5 cm interincisal distance)
- •Absence of opposing dentition or lower prosthesis
- •Acute or chronic infection in the intended implant site
- •Untreated active periodontal disease
- •Poor oral hygiene motivation
- •Radiographic signs of sinus membrane inflammation or ostium obstruction
结局指标
主要结局
Implant Success Rate of Zygomatic Fixtures
时间窗: 5 years after implant placement
The success of each zygomatic implant will be assessed clinically by evaluating the absence of pain, absence of mobility or rotation under contra-torque testing, and the presence of healthy peri-implant tissues. Clinical evaluation will be supported by radiographic analysis to confirm peri-implant bone maintenance and the absence of pathological signs.
次要结局
- Surgical Site Preparation Time(Intraoperative (during implant placement))
- Radiographic Evaluation of Peri-Implant Bone(At prosthesis delivery, and at 1, 3, and 5 years post-loading)
- Peri-implant Probing Depth (PD)(1, 3, and 5 years after functional loading)
- Number of Implants with Bleeding on Probing (BOP)(1, 3, and 5 years after functional loading)
- Number of Implants with Suppuration(1, 3, and 5 years after functional loading)
研究者
Pietro Felice
Principal Investigator, Head of Oral Surgery, Clinical Professor
University of Bologna