Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

NCT ID: NCT00752089

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-01-31

Brief Summary

The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

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. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.

Conditions

Dental Erosion

Keywords

enamel fluoride uptake; erosion; enamel remineralization

Study Design

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

Study Groups

Sodium fluoride/potassium nitrate/Isopentane dentifrice

Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient.

Group Type: EXPERIMENTAL

NaF/ KNO3/isopentane Dentifrice

Intervention Type: DRUG

Experimental toothpaste

NaF/KNO3 Dentifrice

Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.

Group Type: EXPERIMENTAL

NaF/KNO3 Dentifrice

Intervention Type: DRUG

Experimental toothpaste

NaF Dentifrice

Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.

Group Type: ACTIVE_COMPARATOR

NaF Dentifrice

Intervention Type: DRUG

Active comparator

Placebo Dentifrice

Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).

Group Type: PLACEBO_COMPARATOR

Placebo Dentifrice

Intervention Type: OTHER

Placebo comparator

Interventions

NaF/ KNO3/isopentane Dentifrice

Experimental toothpaste

Intervention Type: DRUG

NaF/KNO3 Dentifrice

Experimental toothpaste

Intervention Type: DRUG

NaF Dentifrice

Active comparator

Intervention Type: DRUG

Placebo Dentifrice

Placebo comparator

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age: Aged between 18 and 78

2. Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons

3. Dentures: 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 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods

4. Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair

5. Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min

6. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions

7. 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

8. 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 participant safety during the study period

Exclusion Criteria

1. Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit

2. Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

3. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.

4. Breast-feeding:Women who are breast-feeding.

5. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit

6. Personnel:An employee of the sponsor or the study site who is directly involved in the study

• 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

Countries

United States

Other Identifiers

Z3120510

Identifier Type: -

Identifier Source: org_study_id