A Prospective Clinical Study to Evaluate the Outcome of Early Loading of Implants in the Maxillary Anterior Region With Alveolar Bone Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- marginal bone resorption
研究概览
简要总结
With the improvement of people's living standards, implant restoration has become an ideal method for partially and completely edentulous patients. Traditional classic implant theory suggests a 3-6 month undisturbed healing period is required before permanent loading can take place. However, this loading plan takes a long time and cannot timely meet the chewing function and aesthetic needs of patients with anterior maxillary tooth loss. Currently, with the continuous improvement of implant design and surface treatment techniques, the speed of implant-bone integration has been increasing, and early loading has gradually become a clinical option.
After carefully reviewing the research conducted by domestic and international scholars on early loading of implants in the anterior maxillary region , we found that the cases included in the articles were patients with anterior maxillary tooth loss who did not require simultaneous guided bone regeneration (GBR) surgery. It is well known that patients with anterior maxillary tooth loss often have significant alveolar bone defects. In such cases, GBR techniques are commonly used to repair the bone defect. However, due to the lack of relevant studies, the clinical loading strategies for implant cases with accompanying bone defects are relatively conservative. Clinically, a delayed loading restoration strategy is usually employed, which typically requires a delay of 6 months or even longer.
However, delayed loading increases the patient's edentulous time, affects the function and stability of the dental arch, and increases the patient's psychological burden. Therefore, whether an early loading strategy can be used for implant cases with alveolar bone defects in the anterior maxillary region has become a key issue in clinical practice. However, there is few research reported on the timing and effectiveness of early loading of implants in the anterior maxillary region with accompanying alveolar bone defects.
This study aims to evaluate the clinical effects of early loading in patients with anterior maxillary single-wall bone defects through a prospective clinical randomized controlled trial.
详细描述
- Research Objectives
This study aims to compare the marginal bone resorption, implant success rate, complication rate, soft tissue condition, and patient satisfaction between early loading and conventional loading of implants in the maxillary anterior region with alveolar bone defects using a combination of prospective clinical control study and three-dimensional finite element analysis. The study aims to explore the clinical effects of early loading of implants in the maxillary anterior region with alveolar bone defects and provide clinical evidence for early loading of implants in this area. 2. Research Design and Methods
2.1 Subject Inclusion Criteria, Exclusion Criteria, and Grouping Criteria According to the purpose of the study, prospective intervention single-center randomized clinical trial was designed. Patients treated with implant restoration in the Oral Implant Center of Stomatology Hospital Affiliated to Zhejiang University School of Medicine, from July 2022 to June 2025 were recruited. The recruited patients were divided into the early loading group with bone defects (referred to as the early loading group) and the conventional loading group with bone defects (referred to as the conventional loading group).
2.1.1Inclusion Criteria: (1)Age: 18-60 years; (2)Gender: Male or Female; (3)Patients with a single missing upper anterior tooth and a labial open-type single-wall bone defect who underwent simultaneous guided bone regeneration (GBR) surgery; (4)Patients choosing the ITI implant system; (5)Patients without a history of systemic diseases such as cardiovascular disease, hypertension, diabetes, etc.;(6)Patients with no history of periodontal disease or have undergone periodontal treatment and can maintain good oral hygiene with no smoking history; (7)Patients without a history of radiation therapy, hepatitis, tuberculosis, or any familial hereditary diseases; (8)Patients with a normal anterior occlusion
Exclusion Criteria:
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)
盲法说明
This study takes a single-blind method. During research process, the researchers and paticipant cannot avoid knowing the time of loading during the clinical examination and operation, so the outcomes assessor can only be single-blinded.The clinical examination data were measured and averaged by two independent clinicians. The data was analysed by a third person.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-60 years;
- •Gender: Male or Female;
- •Patients with a single missing upper anterior tooth and a labial open-type single-wall bone defect who underwent simultaneous guided bone regeneration (GBR) surgery;
- •Patients choosing the ITI implant system;
- •Patients without a history of systemic diseases such as cardiovascular disease, hypertension, diabetes, etc.;
- •Patients with no history of periodontal disease or have undergone periodontal treatment and can maintain good oral hygiene with no smoking history;
- •Patients without a history of radiation therapy, hepatitis, tuberculosis, or any familial hereditary diseases;
- •Patients with a normal anterior occlusion.
排除标准
- •Patients with bone defects other than labial open-type single-wall bone defects in the anterior region;
- •Patients with multiple consecutive missing upper anterior teeth;
- •Patients with a history of systemic diseases, infectious diseases, or familial hereditary diseases;
- •Patients with poor oral hygiene;
- •Patients with bruxism or teeth clenching.
结局指标
主要结局
marginal bone resorption
时间窗: 1-2years
The degree of bone resorption at the shoulder edge of the implant. Bone level was measured by a single reader on CBCT taken after implant surgery, temporary restoration, final restoration, and at the 12-month follow-up.
次要结局
- PES index(1-2years)
- probing bleeding index(1-2years)
- Implant Success Rate(1-2years)
- probing depth(1-2years)
- Satisfaction assessed by the VAS(1-2years)
- Complication rate(1-2years)
研究者
Entang Wang
Attending
The Dental Hospital of Zhejiang University School of Medicine