Viewing Study NCT01473537



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Last Modification Date: 2024-10-26 @ 10:43 AM
Study NCT ID: NCT01473537
Status: COMPLETED
Last Update Posted: 2012-09-25
First Post: 2011-11-14

Brief Title: Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium
Sponsor: Karolinska Institutet
Organization: Karolinska Institutet

Study Overview

Official Title: A Double Blind Randomized Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
Status: COMPLETED
Status Verified Date: 2012-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Fluor-Ca
Brief Summary: Aim to determine the optimal Ca2 concentration with 905 ppm F as NaF Study design Experimental study in 10 volunteers Single blind mouth rinse with calcium lactate solution 150 75 0 mM Ca-lactate is immediately followed by a standard fluoride rinse

Procedure Rinses are performed in the evening The rinse combinations are given in a random order and the subjects are unaware of the sequence At least 3 days separates the use of each rinse Dosage 20 mL and 1 minute rinse with each solution

Saliva samples Twelve hours after rinsing unstimulated saliva samples are collected by expectoration

Analysis The fluoride concentration in saliva samples are analysed Statistics and data handling Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA repeated measures design
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2011-001885-16 EUDRACT_NUMBER None None