The Relationship Between Bone Particles Sizes and the Stability of Soft and Hard Tissue in Aesthetic Area ：3-year Prospective Intervention Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The labial horizontal alveolar bone thickness
研究概览
简要总结
After implant restoration, the surrounding tissue, including the gingiva and alveolar bone, will inevitably reconstruct. The study found that gingival recession was easy to occur in the aesthetic area of upper anterior teeth within 1 year after implantation, which was mainly due to the absorption of labial alveolar bone. In order to avoid absorption, the thickness of the labial bone plate should not be less than 2mm, which is difficult to achieve in the anterior tooth area. Therefore, guided bone regeneration (GBR) should be performed in the implant area, which can provide more than 5mm bone increment in the vertical and horizontal positions with long-term stability, being beneficial for the maintenance of the buccal contour and the stability of the soft and hard tissues in the aesthetic area.
In this study, the inorganic bone matrix extracted from bovine bone (Geistlich, Gegreen, Haiao, etc.) was used for GBR in the area with insufficient bone volume in the anterior dental implant area. The commercially available xenogeneic bone graft substitutes can be divided into large particles (1-2mm) and small particles (0.25-1mm) according to the particle size. Previous studies have found that in 6 months after implantation, the change of vertical bone height around the implant (i.e. the height from the top of alveolar ridge to the shoulder of the implant) is related to the particle size of bone powder, and large particles of bone powder may have better performance in maintaining the vertical bone height due to the following reasons:
- Large bone particles may show better mechanical properties and better mechanical compression resistance.
- Large bone particles may show more reasonable pore size and porosity, which may provide better environment for the growth of new bone.
- Large bone particles may achieve more reasonable and balanced bone remodeling. However, the effect of bone particle sizes on the maintenance of soft and hard tissue around the bone graft area is still inconclusive. Thus, the purpose of this study is to compare the effects of large and small bone particle sizes on the stability of soft and hard tissues around the bone graft area within 3 years after implant restoration in the anterior tooth area.
详细描述
Research Purpose: To compare the effects of large and small bone particle sizes on the stability of soft and hard tissues around the GBR area within 3 years in the esthetics area of anterior tooth.
Research Design and Methods:
- Type of study design: prospective intervention single-center randomized clinical trial.
- Study period: 3 years, from the date of ethics approval to December 2025.
- This study takes a single-blind method. During research process, the researchers can't avoid knowing the type of abutment used by the subjects during the clinical examination and operation, so the subjects can only be single-blinded.
- Measures to control bias:
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Selection bias control: the random number table method was used for grouping, and the blind method was strictly followed in the research process. During the recruiting period, researchers need to be fully informed of the subjects to improve their understanding and compliance with the test. At least two or more contact information should be left in case of minimizing the missed follow-up, and we can contact the subjects in emergency.
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Control of information bias: rigorous design of case report form, setting up two researchers to collect data independently and try to collect the data of objective indicators, conduct regular researcher training and unify the evaluation 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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This study takes a single-blind method. During research process, the researchers cannot avoid knowing the type of abutment used by the subjects during the clinical examination and operation, so the subjects can only be single-blinded. The clinical examination data will be measured and averaged by two independent clinicians. The data will be analyzed by a third person.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and above
- •Patients with missing maxillary anterior teeth and insufficient horizontal bone mass of alveolar ridge who indeed need GBR
- •One-wall or two-wall bone defects
- •There is no infection and tooth extraction residue at the implant site
- •Simultaneous implant placement
- •Subjects who voluntarily join the test cohort and sign the informed consent
排除标准
- •Severe periodontitis or uncontrolled periodontitis
- •History of head and neck radiotherapy
- •History of bisphosphonate administration and injection
- •Uncontrolled severe systemic diseases
- •Patients with heavy smoking
- •Onlay bone graft is needed for bone resorption
- •Three-wall or four-wall bone defects
结局指标
主要结局
The labial horizontal alveolar bone thickness
时间窗: pre-surgery, immediately post-surgery, 6 months after operation, 1/2/3-year after implant restoration
Horizontal bone thickness of implant shoulder, 2mm below the shoulder, 4mm below the shoulder, and 6mm below the shoulder.
The change of Pink esthetic score (PES) from baseline
时间窗: The day of completion of implant restoration, 0.5/1/2/3-year after implant restoration
Gingival tissue information collection include mesial and distal gingival papilla, soft tissue color, texture, level and contour, and alveolar ridge. The minimum value is 0, and the maximum value is 14, the higher scores mean a better outcome.
次要结局
- The change of Vertical facial alveolar bone level (VFBL) from baseline(The operation day, 6 months after operation, 1/2/3-year after implant restoration)