Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

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.

Study Overview

• Status: Withdrawn
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Toothpaste containing 1150ppm F; Drug: Toothpaste containing 1150ppm F; Other: Toothpaste containing 0ppm F; Drug: Toothpaste containing 250ppm F

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test fluoride toothpaste; Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods	Drug: Toothpaste containing 1150ppm F; US marketed toothpaste containing 1150ppm of F; Drug: Toothpaste containing 1150ppm F; Experimental toothpaste containing 1150ppm F
PLACEBO_COMPARATOR: Fluoride free (0ppm F) reference control toothpaste; Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.	Other: Toothpaste containing 0ppm F; Experimental toothpaste containing 0ppm F
ACTIVE_COMPARATOR: Low dose fluoride (250ppm F) reference control toothpaste; Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.	Drug: Toothpaste containing 250ppm F; Experimental toothpaste containing 250ppm F
ACTIVE_COMPARATOR: Fluoride (1150ppm F) reference control toothpaste; Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.	Drug: Toothpaste containing 1150ppm F; US marketed toothpaste containing 1150ppm of F; Drug: Toothpaste containing 1150ppm F; Experimental toothpaste containing 1150ppm F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste	The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments	The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)	4 weeks
Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments	The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth)	4 weeks
Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments	The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax)	4 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ANTICIPATED): November 1, 2016
• Study Completion (ANTICIPATED): November 1, 2016

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (ESTIMATE): May 6, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 203161