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

NCT07442136 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CRO-2025-06-ERO-MS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enamel Erosion

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Test

EXPERIMENTAL

Participants will brush with a new toothpaste Containing SnF for two minutes twice daily.

Drug: New Toothpaste Containing SnF

Control

PLACEBO COMPARATOR

Participants will brush with a regular fluoride toothpaste for two minutes twice daily.

Drug: Fluoride Toothpaste

Interventions

New Toothpaste Containing SnF DRUG

Participants will brush with a new toothpaste containing SnF for two minutes twice daily.

Test

Fluoride Toothpaste DRUG

Participants will brush with a regular fluoride toothpaste twice daily for two minutes.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

School of Dentistry, University of Texas Health San Antonio

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: March 2, 2026
• Study Start: March 3, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)