Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

NCT02436473 | Withdrawn

• 1 other identifier: 203161
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments

  4 weeks

• Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments

  4 weeks

• Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments

  4 weeks

Study Arms (4)

Test fluoride toothpaste

EXPERIMENTAL

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

Fluoride free (0ppm F) reference control toothpaste

PLACEBO COMPARATOR

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

Low dose fluoride (250ppm F) reference control toothpaste

ACTIVE COMPARATOR

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

Fluoride (1150ppm F) reference control toothpaste

ACTIVE COMPARATOR

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

Interventions

Toothpaste containing 1150ppm F DRUG

US marketed toothpaste containing 1150ppm of F

Test fluoride toothpaste

Toothpaste containing 0ppm F OTHER

Experimental toothpaste containing 0ppm F

Fluoride free (0ppm F) reference control toothpaste

Toothpaste containing 250ppm F DRUG

Experimental toothpaste containing 250ppm F

Low dose fluoride (250ppm F) reference control toothpaste

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demonstrates understanding of the study.
• Aged 18 to 85 years.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Has good general health (in the opinion of the investigator or medically qualified designee).
• Currently living in the Indianapolis, Indiana area.
• Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
• Have no current active caries or periodontal disease and all restorations in a good state of repair.
• Have a salivary flow rate in the range of normal values.

You may not qualify if:

• Pregnant or breast feeding women.
• Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
• Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
• Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
• Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
• Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
• Recent history (within the last year) of alcohol or other substance abuse.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 6, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 13, 2015

Record last verified: 2015-08