Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion
July 16, 2026 updated by: Colgate Palmolive
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
Completed
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- School of Dentistry, University of Texas Health San Antonio
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Test
Participants will brush with a new toothpaste Containing SnF for two minutes twice daily.
|
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.
|
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
Time Frame: From baseline to the end of treatment at 10 days.
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2026
Primary Completion (Actual)
June 1, 2026
Study Completion (Actual)
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)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 16, 2026
Last Verified
July 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.