Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human: a Split-mouth Randomized Triple-blind Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Fractal dimension
研究概览
简要总结
The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in human dental sockets.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic need for bilateral extraction of lower first premolars
排除标准
- •Alcoholism, smoking, drug use and abuse of drugs; Systemic diseases: uncontrolled diabetes, blood dyscrasias, kidney or heart failure and osteoporosis; clinical or radiographic signs of pathological processes in the bone;
研究组 & 干预措施
hyaluronic acid
Immediately after the extractions, one socket was randomly filled with 1% hyaluronic acid gel.
干预措施: hyaluronic acid (Drug)
Blood clot
Immediately after the extractions, the other side socket was naturally filled with blood clot.
干预措施: Placebo (Other)
结局指标
主要结局
Fractal dimension
时间窗: 90 days after extraction and treatment application
During the postoperative interval of 90 days, the patients underwent cone beam computed tomography (CBCT). Five central transverse scan images were captured from each socket. The pattern of the alveolar trabecular bone was also evaluated through the fractal dimension in each image.
Dimensional Alveolar changes
时间窗: 30 to 90 days after extraction and treatment application
To determine whether treatment could prevent loss of buccolingual thickness, was compared bone loss of 90 to 30 days between the treated and control groups.
Percentage of bone formation
时间窗: 90 days after extraction and treatment application
During the postoperative interval of 90 days, the patients underwent cone beam computed tomography (CBCT). Five central transverse scan images were captured from each socket. Using the KS300 software, the gray intensity was measured in each image and the results were expressed as mean percentage of bone formation
次要结局
未报告次要终点
研究者
Carlos Eduardo Pinto de Alcântara
MSc,PhD Student, Professor
Federal University of Minas Gerais