Clinical Trial on the Safety and Efficacy of Magnesium Doped Calcium Silicate 3d Alveolar Bone Repair Unit for Periodontal Bone Defects
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Horizontal bone width
研究概览
简要总结
The goal of this clinical trial is to test in height increment of alveolar bone and safety evaluation index.
The main question it aims to answer are:
• The safety and effectiveness of magnesium calcium silicate three-dimensional alveolar bone repair unit in the repair of periodontal bone defects Participants will be treated through Guided Bone Regeneration operation with calcium magnesium silicate three-dimensional alveolar bone repair unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old, healthy;
- •Good oral hygiene, do not smoke;
- •There is bone defect at the tooth extraction site, and it is planned to carry out implant repair after tooth extraction;
- •There is at least one healthy adjacent tooth in the mesial and distal surface of the tooth extraction site;
- •The residual height from the bottom of the extraction socket to the crest of the alveolar ridge is ≥ 3 mm, with at least one bone wall;
- •Can understand the purpose of the trial
- •Be willing to cooperate with surgical treatment and follow-up, voluntarily participate in the trial
- •Sign the informed consent form.
排除标准
- •The affected tooth is in the acute inflammatory stage;
- •Those who have bad habits such as smoking and drinking；
- •Subjects who cause artifacts in oral imaging examination, such as the extraction site and its adjacent teeth are metal Dentures, porcelain teeth;
- •Patients are allergic to ceramic implants;
- •Those who have participated in other clinical trials in the past 3 months;
- •The investigator estimated that the compliance was poor, or there were other factors that were not suitable for the test;
- •Patients with a history of diabetes or abnormal blood glucose detection (fasting blood glucose ≥ 7mmol/L);
- •Abnormal liver and kidney function (AST, ALT, creatinine ≥ 1.5 times ULN);
- •Patients with serious endocrine and metabolic diseases;
- •Have a history of tertiary hypertension;
- •Have a history of osteoporosis;
- •Those who are not suitable for surgery due to the history of malignant tumor or other serious diseases;
- •People with a history of autoimmune diseases;
- •Pregnant or lactating women;
- •Mental disorders without autonomous behavior ability;
- •Patients who are using steroids that interfere with calcium metabolism within 3 months before the signing of informed consent
结局指标
主要结局
Horizontal bone width
时间窗: 24 weeks after operation
The width of buccal lingual alveolar ridge was measured 1 mm below the crest of alveolar ridge.
Evaluation of wound healing
时间窗: 2 weeks after operation
The wound healing evaluation scale was modified according to the indicators described by Lobene et al (1986) and will be used to evaluate the wound healing after surgery. The gingival tissue in the material implantation area was evaluated.
次要结局
未报告次要终点