A Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorColgate Palmolive

About this trial

The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female subjects, ages 18-70, inclusive.

Subject is available during study duration and has no allergies to oral hygiene formulations.

A minimum of 20 natural teeth with facial and lingual scorable surfaces.

A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.

Disqualifiers

Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.

History of dental prophylaxis or treatments in the past month or during study duration.

History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.

Subjects scheduled for medical procedures for the duration of the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • stannous fluoride toothpaste

    Drug

    toothpaste

  • 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste

    Drug

    toothpaste

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Test 1 ToothpasteExperimental treatment 1 intervention
Group B: Test 2 toothpasteActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Loe-Silness

gingivitis index of 1.0 or more

Time frame
baseline, 2 week and 4 week
2

Turesky Modification of Quigley-Hein

whole mouth scores of dental plaque of 1.5 or more

Time frame
baseline, 2 week and 4 week

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: