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临床试验/NCT05595070
NCT05595070Enrolling By Invitation不适用

Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年4月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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