DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dental Caries

Intervention: calcium lactate solution (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Karolinska Institutet

Official(s) and/or principal investigator(s):
Gunilla Sandborgh-Englund, Prof, DDS, Principal Investigator, Affiliation: Karolinska Institutet

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.

Clinical Details

Official title: A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Fluoride concentration in resting saliva

Secondary outcome: Discomfort by calcium lactate rinse

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 years or older

- 10 natural teeth or more

- willing to refrain from use of fluoride containing products

- signed informed consent

Exclusion Criteria:

- less than 10 natural teeth

- reduced cognitive skills

- does not speak and/or understand Swedish

- ongoing oral or systemic infections

- pregnancy

- breast feeding

Locations and Contacts

Karolinska Institutet, Dept Dental Medicine, Huddinge SE14104, Sweden
Additional Information

Starting date: October 2011
Last updated: September 21, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017