Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

Dental Caries Clinical Trial

Official title:

Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02436473
• Other study ID #: 203161
• Status: Withdrawn
• Phase: N/A
• First received: May 4, 2015
• Last updated: August 10, 2015
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Demonstrates understanding of the study.

2. Aged 18 to 85 years.

3. Understands and is willing, able and likely to comply with all study procedures and restrictions.

4. Has good general health (in the opinion of the investigator or medically qualified designee).

5. Currently living in the Indianapolis, Indiana area.

6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.

7. Have no current active caries or periodontal disease and all restorations in a good state of repair.

8. Have a salivary flow rate in the range of normal values.

Exclusion Criteria:

1. Pregnant or breast feeding women.

2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.

3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.

4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.

5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.

6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment.

7. Recent history (within the last year) of alcohol or other substance abuse.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Toothpaste containing 1150ppm F
US marketed toothpaste containing 1150ppm of F

Other:
• Toothpaste containing 0ppm F
Experimental toothpaste containing 0ppm F

Drug:
• Toothpaste containing 250ppm F
Experimental toothpaste containing 250ppm F
• Toothpaste containing 1150ppm F
Experimental toothpaste containing 1150ppm F

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net remineralization change (?M) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste	The change in mineral content (?M) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ?M= (Post-treatment ?Z - baseline ?Z)	4 weeks	No
Secondary	Net remineralization change (?M) of demineralised enamel specimens following use of the test toothpaste with all other treatments	The change in mineral content (?M) of the lesions as measured by TMR will be calculated by the following formula: ?M= (Post-treatment ?Z - baseline ?Z)	4 weeks	No
Secondary	Changes in enamel lesion depth (?L) following use of the test toothpaste with all other treatments	The change in lesion depth (?L) as measured by TMR will be calculated by: ?L= (Post-treatment lesion depth - baseline lesion depth)	4 weeks	No
Secondary	Net change in surface zone mineral content (?SZmax) following use of the toothpaste with all other treatments	The change in SZmax (?SZmax) as measured by TMR will be calculated by: ?SZmax= (Post-treatment SZmax - baseline SZmax)	4 weeks	No