Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion

The goal of this clinical trial is to learn if a new toothpaste can prevent enamel erosion in healthy adults. Researchers will compare the test toothpaste to a control toothpaste to see if there is a difference in erosion levels. Participants will brush twice a day for two minutes with their assigned toothpaste.

Study Overview

• Status: Active, not recruiting
• Conditions: Enamel Erosion
• Intervention / Treatment: Drug: New Toothpaste Containing SnF; Drug: Fluoride Toothpaste

Detailed Description

The objective of this clinical study is to assess the efficacy of New Toothpaste Containing SnF as compared to commercially available toothpaste in the reduction of enamel erosion over a ten (10) days period. This investigation will be a randomized, double-blinded, single-center, parallel clinical study. Subjects will be randomly assigned to one of the two study groups, and will be instructed to use their assigned toothpaste for a period of ten (10) days.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • School of Dentistry, University of Texas Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sign an Informed Consent Form;
• Male or female 18 to 70 years of age, inclusive;
• Be in good general health as determined by the study investigators;
• Available for the eighteen (18) days duration of the study;
• Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary saliva examination;
• Have healthy salivary pH (unstimulated saliva pH 6.8-7.8) ascertained from a preliminary saliva test;
• Must be able to accept a well-fitting removable intraoral appliance bearing at least two enamel specimens.

Exclusion Criteria:

• Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
• Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
• Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months;
• Obvious signs of dental erosion Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
• Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics, or medication which alters salivary flow
• Participation in any other oral clinical study for the duration of this study
• Self-reported pregnancy and/or currently breastfeeding;
• Allergies to oral care products, personal care consumer products, and/or their ingredients;
• Medical condition which prohibits not eating/drinking for 4 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Participants will brush with a new toothpaste Containing SnF for two minutes twice daily.	Drug: New Toothpaste Containing SnF; Participants will brush with a new toothpaste containing SnF for two minutes twice daily.
Placebo Comparator: Control; Participants will brush with a regular fluoride toothpaste for two minutes twice daily.	Drug: Fluoride Toothpaste; Participants will brush with a regular fluoride toothpaste twice daily for two minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface loss	Depth of surface loss in an enamel block worn on a dental retainer by the participant, as determined by an optical profilometer.	From baseline to the end of treatment at 10 days.

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Collaborators: The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CRO-2025-06-ERO-MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No