Oral Hygiene Assistance Training Program
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Incidence of pneumonia
研究概览
简要总结
This is an oral health study with a nursing home staff training program and product intervention.
详细描述
This study will be completed in partnership with the Missouri Department of Health and Senior Services, McCoy Samples Mattingly Dental Clinic, and Feno, inc. The study involves a nursing home staff training program, product intervention, and oral health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form to receive on-site dental care and grant access to their medical and dental records, and Consent for information collection, consultation, and disease control oral healthcare treatment
- •Male and female subjects aged 60 years or older.
- •A resident of one of the nursing home sites.
- •ASA physical classification status of II, III, or IV (excluding high frailty scores)
- •Frailty assessment of low or moderate
排除标准
- •Tumor(s) of the soft or hard tissues of the oral cavity.
- •History of allergies to oral care/personal care consumer products or their ingredients.
- •ASA category V patients
- •High frailty assessment
- •Resident deemed behaviorally difficult in interview or initial assessment
- •Endentulous
- •Fractured teeth and/or root tips present
- •Oral lesions
- •Grossly mobile teeth for Cohort B
- •Temporary crowns for Cohort B
研究组 & 干预措施
Cohort A
Subjects in this arm of the trial will use a manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.
干预措施: Stannous Fluoride Toothpaste (SnF) (Drug)
Cohort A
Subjects in this arm of the trial will use a manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.
干预措施: sodium fluoride 5000 ppm (Drug)
Cohort A
Subjects in this arm of the trial will use a manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.
干预措施: sodium fluoride Mouthwash (Drug)
Cohort A
Subjects in this arm of the trial will use a manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.
干预措施: Chlorhexidine 0,12% (Drug)
Cohort B
Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash.
干预措施: sodium fluoride Mouthwash (Drug)
Cohort B
Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash.
干预措施: Chlorhexidine 0,12% (Drug)
Cohort B
Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash.
干预措施: connected toothbrush (Device)
Cohort B
Subjects in this arm of the trial will use a smart toothbrush, a cosmetic toothpaste, and an OTC and/or Rx mouthwash.
干预措施: xylitol toothpaste (Other)
Cohort A
Subjects in this arm of the trial will use a manual or power toothbrush, OTC and/or Rx toothpaste, and OTC and/or Rx mouthwash.
干预措施: cetylpyridinium chloride (0.075%) and zinc alcohol free mouthwash (Drug)
结局指标
主要结局
Incidence of pneumonia
时间窗: 1 year
Incidence of pneumonia acquired during the study
次要结局
- Diabetes status(every 3 months for 1 year)
- HbA1c value(Every 3 months for 1 year)
- Oral Health History(Baseline)
- Oral Health Status(Monthly for one year)
- Level of adherence to oral hygiene regimen(Monthly for 1 year)
- Satisfaction with program(1 year)