Salivary Levels of Fluoride and Silver 7 Days After Treatment With Diammine Silver Fluoride
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Silver and Fluoride levels in saliva
研究概览
简要总结
The aim of the study is to measure salivary fluoride and silver levels up to 7 days post-treatment.
The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to use the day before the study and all during the study.
3 participants will have 6 teeth treated (Group A).3 participants will have 28 teeth treated each on the facial aspect (Group B).
On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3 times.
On day 0, 10 minutes after the rinsing and spitting, the participant will provide a unstimulated salivary sample into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.
On Day 0, Isolation and application of silver fluoride.
The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with petroleum jelly to provide additional protection.
After application, participant will be given 25 ml of fluoride free water to rinse as in 1 above and water collected. This will be done 10 times.
DAY 1-6 Salivary Collection
Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry (EPA 6020a Rev.1 2007) at the University of Washington
详细描述
Aim: to measure salivary fluoride and silver levels up to 7 days post-treatment. Based on extrapolation of the study by Vasquez and colleagues (2012), it is hypothesized that 7-day levels in the clinical study will not exceed baseline values.
Participants: 6 healthy adults of either sex, 21+ years old, who do not have gingivitis but who have generalized gingival recession >1mm, 3 subjects must have at least 28 teeth.
Participants will be given a fluoride free toothpaste to use the day before the study and all during the study. Participants will be reminded not to use fluoride toothpaste or other fluoride products and to avoid fish and tea.
No toothbrushing or eating at all within an hour of any visit
Design: Observational study with each participant as his/her own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least one canine or premolar
- •Patients with Dentin hypersensitivity
- •Patients with healthy gingiva
排除标准
- •Patients taking any of these medication: antidepressivem anticonvulsive, antihistaminic, antihypertension, antihemetic, antiespasmodic.
- •Pregnancy
- •Patients under radiation therapy
- •Patients under chemotherapy
- •Patients with alterations of salivary glands like Sjogren syndrome or Diabetes Mellitus with Xerostomia
- •Patients with sensitivity to silver or other ions of heavy metals
结局指标
主要结局
Silver and Fluoride levels in saliva
时间窗: 7 days
The daily fluoride and silver levels in saliva will be determined after the application of silver fluoride.
次要结局
未报告次要终点