Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

GlaxoSmithKline (GSK)

Status: Withdrawn

Conditions: Dental Caries

Treatments: Other: Toothpaste containing 0ppm F; Drug: Toothpaste containing 250ppm F; Drug: Toothpaste containing 1150ppm F

Study type: Interventional

Funder types: Industry

Identifiers

NCT02436473

203161

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 4 patient groups, including a placebo group

Test fluoride toothpaste

Experimental group

Description:

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

Treatment:

Drug: Toothpaste containing 1150ppm F

Drug: Toothpaste containing 1150ppm F

Fluoride free (0ppm F) reference control toothpaste

Placebo Comparator group

Description:

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.

Treatment:

Other: Toothpaste containing 0ppm F

Low dose fluoride (250ppm F) reference control toothpaste

Active Comparator group

Description:

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.

Treatment:

Drug: Toothpaste containing 250ppm F

Fluoride (1150ppm F) reference control toothpaste

Active Comparator group

Description:

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.

Treatment:

Drug: Toothpaste containing 1150ppm F

Drug: Toothpaste containing 1150ppm F