In Situ Caries of Fluoride Toothpastes

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Healthy Subjects; Partial Denture Wearers; Caries

Treatments: Drug: Placebo toothpaste; Drug: Sodium fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708123

T3157503

Details and patient eligibility

About

This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model.

Full description

Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources [sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)] using an in situ caries model.

Enrollment: 60 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
2. Age:Aged between 18 and 78 years.
3. Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
4. General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period.
5. Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair.
6. Salivary Flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 ml/minute; gum base stimulated whole saliva flow rate = 0.8 ml/minute).

Exclusion Criteria

1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
2. Breast-feeding:Women who are breast-feeding.
3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
4. Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
5. Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit.
6. Fluoride:Taking fluoride supplements for medical reasons.
7. Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects.
8. Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F]

Active Comparator group

Description:

Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Treatment:

Drug: Sodium fluoride toothpaste

NaF/Carbopol toothpaste (1400 ppm F)

Experimental group

Description:

Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Treatment:

Drug: Sodium fluoride toothpaste

NaMFP/NaF toothpaste (1450 ppm F)

Active Comparator group

Description:

Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Treatment:

Drug: Sodium fluoride toothpaste

NaF toothpaste (250 ppm F)

Active Comparator group

Description:

Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Treatment:

Drug: Sodium fluoride toothpaste

Placebo toothpaste (0 ppm F)

Placebo Comparator group

Description:

Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.

Treatment:

Drug: Placebo toothpaste