In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes

Dental Caries Clinical Trial

Official title:

In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629290
• Other study ID #: HUM00062943
• Status: Completed
• Phase: N/A
• First received: June 10, 2012
• Last updated: January 25, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will be a cross-over single blinded clinical study to evaluate the in vitro fluoride release of three different brands of 5% NaF varnish. Subjects will be recruited at the University of Michigan School of Dentistry and will participate in a 15 minute clinical session at the beginning of each study arm, followed by 6 saliva collection recalls. During these sessions a fluoride varnish or placebo will be applied to their teeth, and subsequent salivary samples will be taken 1 hour, 4 hours, 6 hours, 24 hours, and 48 hours after the application. All subjects will receive 3 commercially available varnishes, and a placebo varnish. Between applications there will be a minimum of 2 weeks wash-out period. The goal of this study is to determine if different formulations of varnish lead to differing amounts of fluoride release. Despite their similar concentrations of NaF (5%), some in vitro data have suggested that they may differ in the amount of fluoride release. Determining fluoride release of these varnishes in vivo is important in assessing both the safety and efficacy of the product.

Specific Aims

1. Determine the concentration of fluoride available in the oral cavity at different time periods after the application of three different 5% NaF varnishes as measured in unstimulated human saliva.

2. Compare the different patterns of fluoride release from each of the varnishes by comparing the fluoride concentration in saliva at corresponding time periods .

3. Evaluate the validity of an in vitro model used to measure fluoride release from varnishes.

Percentage difference in fluoride release between the in vivo and in vitro data obtained from the same products will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All subjects between 18-65 years of age and do not fall under any of the exclusion criteria

Exclusion Criteria:

• Subjects with less than 20 teeth

• Subjects with significant untreated disease to include gum disease, extensive decay, or the need for pre-medication prior to dental treatment

• Pregnant or lactating women

• Subjects with a history of allergy to materials to be used in the study

• Subjects unable to produce adequate saliva for sampling

• Subjects deemed low risk for dental caries (no history of restorative work or presence of caries lesions)

• Subjects unable to be available for all 4 cycles of the study

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Dental Varnish (Enamel Pro, Duraphat, Vanish)
3 varnishes with 5% NaF active ingredient and one bland varnish (No NaF)
• Placebo
0.5 mls applied topically to buccal surfaces of teeth

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Delta Dental Fund of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the concentration of fluoride available in the oral cavity at different time periods after the application of three different 5% NaF varnishes as measured in unstimulated human saliva		48 Hours	No
Secondary	Compare the different patterns of fluoride release from each of the varnishes		48 Hours	No