Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Calcium Phosphosilicate
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Bone Volume change
研究概览
简要总结
The goal of this clinical study is to learn if cone beam computed tomography (CBCT) or 3-dimensional x-ray can help to let the investigator know if dental implant placement can be done after performing closed sinus surgery.
The study will look at the structure of your gum where the implant will be placed after performing the surgery using 3-D x-ray and compare that to how the structure of your gum looks 6 months later.
The 3-D imaging will happen after standard of care surgery to prepare your gum for an implant and then 6 months later to verify that the site is ready for the implant.
详细描述
While you are taking part in this study, participants will be asked to attend approximately two visits with the researchers or study staff. For research purposes, one visit is the surgical appointment and a postoperative visit at six months, these will likely be scheduled at standard of care visits.
If the participant elects a dental implant for tooth replacement, your sinus grafting will be performed, and the dental implant will be placed on the same appointment.
Study Procedures - as a participant in this research, you will undergo the following procedures:
- Immediately upon completion of your sinus grafting and dental implant placement a three-dimensional x-ray will be taken in the Graduate Periodontics clinic.
- At six months following your dental implant placement an additional three-dimensional x-ray will be taken in the Graduate Periodontics clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability of participant to understand and the willingness to sign a written informed consent document.
- •English speaking.
- •Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c (glycated glucose)< 7.
- •Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement
- •At minimum 5mm of native bone below the maxillary sinus inferior border
排除标准
- •Maxillary sinus disease
- •Diabetes diagnosis with a current HbA1c > 7.1 or greater due to diabetes effect on bone metabolism
- •Pregnant or attempting to become pregnant
- •Having a disease that affects bone metabolism
- •Use of medications known to affect bone metabolism
- •Tobacco, cannabis or vaping use
- •Alcoholism or other recreational drugs
研究组 & 干预措施
Closed sinus augmentation with Calcium Phosphosilicate Putty
Use of CBCT immediately post-operatively after placement of Calcium Phosphosilicate Putty used as standard of care for closed sinus augmentation and at 6 months after surgery.
干预措施: Low volume CBCT (Procedure)
结局指标
主要结局
Bone Volume change
时间窗: Baseline to 6 months
Bone volume changes will be reported as a percentage, with mean, median, and standard deviation.
次要结局
未报告次要终点