Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Unstimulated and chewing stimulated salivary pH
研究概览
简要总结
Haematopoietic stem cell transplantation (HSCT) is a potentially lifesaving treatment option for various diseases. It involves infusion of stem cells after a conditioning regimen of chemotherapy with or without total body irradiation. There is a concern that HSCT and accompanying treatments may increase the risk for oral complications. Nevertheless, longitudinal studies measuring oral health before and after HSCT are scarce. Hence, we formulated the following research question:
In adult HSCT recipients, do oral health parameters change from baseline (pre-HSCT) to 3 - 24 months post-HSCT, and is the type of conditioning regimen associated with this change in oral health parameters?
To answer this research question, we will use data from the electronic health records of the Radboudumc (Epic and Dentium). We will include at least seventy-five adult patients who are examined both before and after HSCT at the department of Dentistry (Radboudumc) as part of an oral care program. The following oral health parameters were assessed: status praesens, pocket probing depth, bleeding on probing, periodontal epithelial surface area, periodontal inflamed surface area, xerostomia, unstimulated and stimulated salivary flow rate and pH, cariesactivity, oral chronic Graft-versus-Host Disease and dental treatments.
Patients were subjected to different regimens in preparation for HSCT, namely myeloablative, reduced intensity or non-myeloablative conditioning. To estimate the association between conditioning regimen and the change in oral health parameters, we will use mixed effects models with random effects, adjusted for potential confounders. Results will be reported as regression coefficients with corresponding 95% confidence intervals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic HSCT between 2013 and 2021 at Radboudumc
- •Oral focal screening before HSCT, and at least one oral examination after HSCT performed at Department of Dentistry, Radboudumc
- •Informed consent
排除标准
- •Not meeting the inclusion criteria
结局指标
主要结局
Unstimulated and chewing stimulated salivary pH
时间窗: Change from baseline (pre-HSCT) up to 24 months after HSCT
Whole mouth saliva, measured with pH strips
Pocket probing depth
时间窗: Change from baseline (pre-HSCT) up to 24 months after HSCT
Pocket probing depth at 6 sites per tooth in millimetres
Number of restorations
时间窗: Change from baseline (pre-HSCT) up to 24 months after HSCT
Total number of restored tooth surfaces
Bleeding on probing
时间窗: Change from baseline (pre-HSCT) up to 24 months after HSCT
Profound bleeding on probing at 6 sites per tooth as yes or no
Number of teeth
时间窗: Change from baseline (pre-HSCT) up to 24 months after HSCT
Number of teeth (range 0 - 32)
Unstimulated and chewing stimulated salivary flow rate
时间窗: Change from baseline (pre-HSCT) up to 24 months after HSCT
Whole mouth saliva, measured in mL/min
次要结局
- Periodontal Epithelial Surface Area(Change from baseline (pre-HSCT) up to 24 months after HSCT)
- Oral chronic Graft-versus-Host Disease(Up to 24 months after HSCT)
- Periodontal Inflamed Surface Area(Change from baseline (pre-HSCT) up to 24 months after HSCT)
- Cariesactivity(Up to 24 months after HSCT)
- Extractions(Between baseline (pre-HSCT) and up to 24 months after HSCT)
- Periodontal care(Between baseline (pre-HSCT) and up to 24 months after HSCT)
- Xerostomia(Change from baseline (pre-HSCT) up to 24 months after HSCT)
- Preventive measures(Between baseline (pre-HSCT) and up to 24 months after HSCT)
