In Situ Caries of Fluoride Toothpastes

NCT ID: NCT00708123

Last Updated: 2013-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-04-30

Brief Summary

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

Detailed 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.

Conditions

Healthy Subjects; Partial Denture Wearers; Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Sodium fluoride toothpaste

Intervention Type: DRUG

Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F

NaF/Carbopol toothpaste (1400 ppm F)

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.

Group Type: EXPERIMENTAL

Sodium fluoride toothpaste

Intervention Type: DRUG

Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F

NaMFP/NaF toothpaste (1450 ppm F)

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.

Group Type: ACTIVE_COMPARATOR

Sodium fluoride toothpaste

Intervention Type: DRUG

Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F

NaF toothpaste (250 ppm F)

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.

Group Type: ACTIVE_COMPARATOR

Sodium fluoride toothpaste

Intervention Type: DRUG

Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F

Placebo toothpaste (0 ppm F)

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.

Group Type: PLACEBO_COMPARATOR

Placebo toothpaste

Intervention Type: DRUG

Fluoride free toothpaste (0 ppm F)

Interventions

Sodium fluoride toothpaste

Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F

Intervention Type: DRUG

Placebo toothpaste

Fluoride free toothpaste (0 ppm F)

Intervention Type: DRUG

Other Intervention Names

Fluoride

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

T3157503

Identifier Type: -

Identifier Source: org_study_id