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临床试验/NCT03281746
NCT03281746终止不适用

Effect of Prevention Education on Factors of Importance in Caries Formation in Pediatric Patients With Leukemia

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Change in salivary flow rate

研究概览

简要总结

This randomized pilot clinical trial studies how well preventive education works in decreasing caries formation in pediatric patients with leukemia. Prevention education may have an effect on factors important in causing cavities in pediatric patients with leukemia.

详细描述

Patients treated for leukemia at Virginia Commonwealth University Medical Center in the department of Pediatric Hematology and Oncology are currently receiving oral hygiene instruction at diagnosis. In this study, patients will be randomized into two groups at diagnosis: one receiving current prevention education and the other group receiving one-on-one prevention education and counseling with the physician and pediatric dental resident. Physician and pediatric dental resident will use motivational interviewing informed techniques during counseling. A caries risk assessment will be performed for each patient at diagnosis. Caries incidence, plaque scores, mutans streptococci levels, salivary flow rate, and salivary pH will be assessed at week one (diagnosis), week 16 or start of interim maintenance therapy whichever comes second, week 32 or beginning of maintenance therapy whichever is later for all patients enrolled in the study. Data will be collected through a clinical intraoral examination and salivary sample. Data collected will be used to assess the effect of increased prevention education on factors of importance in caries formation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients who have been recently diagnosed with leukemia
  • Patients will also predictably be in primary or mixed dentition
  • Patients of Virginia Commonwealth University Medical Center Pediatric Hematology Oncology Clinic

排除标准

  • Full permanent dentition
  • Primary language is not English
  • Children in the custody of the state with no parent or legal guardian present to sign consent

结局指标

主要结局

Change in salivary flow rate

时间窗: Baseline up to 32 weeks

Change in salivary flow rate will be measured utilizing pre-weighed cotton rolls. Patients will saturate as many cotton rolls as possible in one minute by chewing. Dose cups and cotton rolls will be weighed prior to and after data collection. The change in weight in grams will be converted to mL of saliva collected.

Change in caries assessed by CAMBRA risk assessment tool

时间窗: Baseline up to 32 weeks

Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)

时间窗: Baseline up to 32 weeks

Change in salivary pH

时间窗: Baseline up to 32 weeks

Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.

Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth

时间窗: Baseline up to 32 weeks

Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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