Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients (ORARAD II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 6
- 主要终点
- Exposed intraoral bone
研究概览
简要总结
The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.
详细描述
This is a prospective cohort study to document long-term dental and other oral outcomes in patients who receive external beam and modern radiation therapy (RT) modalities with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-two participants were enrolled in the original study, ORARAD, which included a baseline oral examination prior to the start of radiation therapy and follow-up examinations and data collection at six-month intervals up to 2 years after the start of RT. The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Enrolled in the original ORARAD study
- •Willing to participate and comply with all study procedures
排除标准
- •Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study (e.g., unable to obtain consent or unable to tolerate an oral examination).
研究组 & 干预措施
Cohorts Interventions Patients receiving head and neck RT
结局指标
主要结局
Exposed intraoral bone
时间窗: 7 years
Exposed intraoral bone is documented clinically by a trained clinical examiner and assessed based on a visual examination of the area, documenting the related tooth numbers or area and the following clinical signs: pain, swelling, induration, sequestrum, thin skin and/or beard loss (i.e. tissue hypoxia), evidence of pathologic fracture, tooth mobility, altered sensation in the affected area. The percentage of patients experiencing exposed bone, their recovery rates, and percent experiencing the signs will be calculated.
Dental Caries
时间窗: 7 years
Dental caries will be ascertained through the examination parameters outlined by NHANES, and the results of this examination with be used to calculate DMFS scores.
Pocket depth (Periodontal Measure 3)
时间窗: 7 years
Pocket depth measured in mm
Bleeding on probing is documented (yes/no) (Periodontal Measure 1)
时间窗: 7 years
Bleeding on probing is documented (yes/no) and a percentage of "yes" responses will be calculated.
Clinical attachment loss (CAL) (Periodontal Measure 2)
时间窗: 7 years
Clinical attachment loss (CAL) measured in mm
Tooth Loss
时间窗: 7 years
"Tooth loss" will be defined as a dental extraction that has been performed or recommended. Change in number of teeth throughout the duration of the study will be documented.
Salivary flow
时间窗: 7 years
Salivary flow is measured by the whole stimulated salivary flow rate. Changes in the rate and any association with other outcomes (e.g., caries) will be calculated.
次要结局
- Compliance with brushing/flossing(7 years)
- Changes in RT-specific quality of life measures(7 years)
- Mortality(7 years)
- Cancer recurrence(7 years)
- Trismus measurements in mm(7 years)
- 7-year use of fluoride(7 years)
- Change in pain scores(7 years)