Evaluation of a Low-fluoride Anticaries Toothpaste

NCT01094210 | Completed DMC

• 1 other identifier: 1R43DE020998-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.

Conditions

Tooth Abnormality

Keywords

Anti-erosion dental benefits

Outcome Measures

Primary Outcomes (3)

• Surface Microhardness

  Strength measurements made at the enamel surface of the enamel specimen

  30 days

• Transverse Microradiography

  X-ray analysis of enamel lesion

  30 days

• Cross-Sectional Microhardness

  Strength measurements made within the enamel lesion of the enamel specimen

  30 days

Study Arms (2)

G1

500 ppm F Test Toothpaste

Drug: Fluorides, Topical

G2

1100 ppm F Control Toothpaste

Drug: Fluorides, Topical

Interventions

Fluorides, Topical DRUG

500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.

G1; G2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This in situ study will recruit 30 adult subjects (between 18-50 years of age). No potential subject will be excluded from this study, regardless of their gender or racial/ethnic origins. However, it is expected that about 18 (60%) of the 30 subjects in the trial will be women. This distribution will allow for meaningful comparisons between gender groups. We will recruit patients attending the clinics of UTHSCSA dental school clinics, which reflect the ethnic mix of the area the clinics serve. However, majority of subjects will be Hispanic due to the high Hispanic prevalence (57.8%) in San Antonio. Thus, minorities will be included at a similar rate to that in the general population attending for dental care,

You may qualify if:

• adult subjects (between 18-50 years of age)

Sponsors & Collaborators

• Indiana Nanotech, LLC: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Dental Diagnostic Clinic within the University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Tooth Abnormalities

Interventions

Fluorides, Topical

Condition Hierarchy (Ancestors)

Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Member

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 26, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 25, 2015

Record last verified: 2011-06

Locations

US (1)