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Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial

NCT06140745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-20

No results posted yet for this study

Summary

To compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with five different aqueous slurries of toothpaste formulations. Percent remineralization (%R), i.e. the % change in ΔZ values relative to ΔZd, will be the primary outcome measure.

Conditions

  • Caries

Interventions

DRUG

0 ppm Fluoride Dentifrice 1

Each subject will use this product during one of the five treatment periods in the crossover study design.

DRUG

1100 ppm NaF Fluoride Dentifrice

Each subject will use this product during one of the five treatment periods in the crossover study design.

DRUG

1500 ppm NaMFP Fluoride Dentifrice

Each subject will use this product during one of the five treatment periods in the crossover study design.

DRUG

0 ppm Fluoride Dentifrice 2

Each subject will use this product during one of the five treatment periods in the crossover study design.

DRUG

0 ppm Fluoride Dentifrice 3

Each subject will use this product during one of the five treatment periods in the crossover study design.

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2021-02-21
Completion
2021-02-21

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06140745 on ClinicalTrials.gov