Efficacy of Three Toothpastes Using an in Situ Caries Model

Summary

This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).

Conditions

• Dental Caries

Interventions

DRUG

0.425 % w/w phytate,1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

DRUG

0.85 % w/w phytate,1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

DRUG

0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

OTHER

0 ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

DRUG

1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

DRUG

0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-02-01

Primary Completion

2016-07-01

Completion

2016-08-11

Countries

• United States

Study Locations