Intensive Preventative Dental Program Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Decayed, Missing and Filled Surfaces Score
研究概览
简要总结
Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. The purpose of this study is to find out if prescription fluoride varnish applied to the teeth every three months during the first year after radiation therapy changes the development of cavities or gum problems.
详细描述
The overall objective of this clinical trial is to determine if oncology practices can reduce dental disease in head and neck cancer patients post radiation therapy. Participants will have fluoride varnish applied at planned oncology follow-up visits and medical oncology providers will be instructed on recognizing dental disease and referring head and neck cancer patients for dental care when needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Aged 18 years and older
- •Willing and able to provide signed and dated consent form
- •Presence of at least 4 natural erupted teeth remaining in the mouth after completion of pre-RT dental management
- •Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
- •Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The participant must be expected to receive at least 4500 cGy to one of the following sites:
- •base of tongue
- •buccal/labial mucosa
- •floor of mouth
- •gingiva/alveolar ridge
- •hard palate
- •hypopharynx
- •maxillary sinus
- •nasal cavity
- •nasopharynx
- •oral cavity
- •oral tongue
- •paranasal sinus/orbit
- •parotid gland
- •retromolar trigone
- •soft palate
- •sublingual gland
- •submandibular gland
- •Willing to comply with all study procedures
- •Willing to participate for the duration of the study
- •RT follow-up planned for one of the selected AH Oncology Specialist Follow-up Sites.
排除标准
- •Receiving palliative RT
- •History of prior curative RT to the head and neck region to eradicate a malignancy.
- •Incarcerated at the time of screening
- •Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.
研究组 & 干预措施
Intensive Preventative Dental Program
head and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments.
干预措施: Fluoride varnish (Drug)
Regular Care
control group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program.
干预措施: Regular Care (Other)
Medical Oncology Team Providers
Medical Oncology care team members (MD, DO, PA, NP, RN) who participate in Intensive Preventative Dental Program.
干预措施: Medical Oncology Care Team (Other)
结局指标
主要结局
Change in Decayed, Missing and Filled Surfaces Score
时间窗: from baseline to 12 months
Decayed, Missing and Filled Surfaces Score (DMFS) is calculated by a calibrated oral examiner as the combined number of of decayed, missing, and/or filled tooth surfaces, from the baseline dental visit DMFS score before starting radiotherapy to the final dental visit DMFS score 12 months following completion of radiation therapy.
次要结局
- Rate of Fluoride Compliance(from baseline to 12 months)
- Rate of Tooth Loss(from baseline to 12 months)
- Rate of Oral Hygiene Compliance(from baseline to 12 months)
- Rate of Routine/Preventative Dental Care(from baseline to 12 months)