Intra Oral Application (IOA) Testing Study of a Stannous Toothpaste

NCT07419672 | Completed

• 1 other identifier: ST-24-U43
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this crossover in-situ study is to determine the fluoride bioavailability and enamel remineralization potential of an experimental, placebo, and a positive control reference toothpaste.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• Percent Surface Microhardness Recovery (%SMHR)

  End of each 9-day test period (three test periods in total)

• Post-treatment fluoride concentration (µg F/g enamel)

  End of each 9-day test period (three test periods in total)

Study Arms (3)

Negative Control Toothpaste

PLACEBO COMPARATOR

Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a negative-control toothpaste and slurry that contains no active fluoride. This arm provides a baseline reference for evaluating enamel fluoride uptake and remineralization responses relative to the test and comparator treatments.

Drug: Negative Control Treatment Slurry (Fluoride-Free)

Comparator

ACTIVE COMPARATOR

Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with a commercially available fluoride toothpaste and slurry of known efficacy in promoting enamel fluoride uptake and surface remineralization. This arm serves as an established reference standard for evaluating the performance of the test formulation.

Drug: Active Comparator Fluoride Treatment (0.454% SnF)

Test Toothpaste

EXPERIMENTAL

Participants will wear an intra-oral appliance (IOA) containing enamel specimens and brush and rinse twice daily with the investigational fluoride toothpaste and slurry. This arm evaluates the ability of the test formulation to promote enamel fluoride uptake and remineralization relative to both the negative control and active comparator treatments.

Drug: Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste)

Interventions

Negative Control Treatment Slurry (Fluoride-Free) DRUG

Fluoride-free toothpaste used with an intra-oral appliance (IOA) containing enamel specimens. Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA, followed by expectoration without rinsing. Used to provide a baseline reference for enamel fluoride uptake and remineralization outcomes in an IOA model.

Negative Control Toothpaste

Active Comparator Fluoride Treatment (0.454% SnF) DRUG

Commercially available stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Serves as an established reference for promoting enamel fluoride uptake and surface remineralization in an IOA model.

Comparator

Test Fluoride Treatment (0.454% SnF) (Investigational Toothpaste) DRUG

Investigational stannous fluoride toothpaste Toothbrushing and rinsing with slurry twice daily for 2 minutes per administration while wearing the IOA containing enamel specimens, followed by expectoration without rinsing. Intended to evaluate enamel fluoride uptake and remineralization performance versus negative control and active comparator treatments in an IOA model.

Test Toothpaste

Eligibility Criteria

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

You may qualify if:

• be 18 years of age or older,
• have the ability to understand the information contained in the informed consent without the need for cognitive or language interpretation from any other person or source,
• read and sign the Informed Consent and other necessary paperwork prior to initiation of study procedures,
• be in good general and oral health based on medical/dental history,
• have an existing useable dental appliance on file with the clinic or be willing to have one (1) or more dental impressions taken so that a dental appliance can be made to wear during the study,
• have a sufficient functional maxillary dentition to support the palatal appliance, and overall the full (maxillary and mandibular) dentition must provide for proper mastication of food, no less than 16 teeth,
• must be able to expectorate ≥ 1.5 ml of non-stimulated saliva over a 5-minute period\*,
• be willing to refrain from using non-study mouthwash, dentifrice, gum, mints, and other non-study oral care products during the entire length of the study (exception: xylitol free gum and mints will be allowed during acclimation/washout periods only),
• be willing to participate in the study, be able to follow the study directions, and be willing to return for all specified visits at their appointed time,
• be willing to refrain from actively participating in another oral care, drug or medical device research study (participation in a marketing/opinion/behavioral study may be allowed so long as the Principal Investigator has provided permission to do so),
• be willing and able to refrain from wearing a nightguard during testing periods (for nightguard wearers only), and
• be willing to postpone all elective dental procedures, at the discretion of the Investigator/Designee, until the study has been completed.
• Subjects who are unable to provide an adequate amount of saliva during the screening visit may be granted the opportunity to return to the dental clinic to try again (one time only) after adequate hydration.

You may not qualify if:

• advanced periodontal disease as characterized by purulent exudate, generalized mobility, etc., or undergoing active treatment for periodontitis,
• pathologic lesions of the oral cavity (suspicious or confirmed; per Investigator/Designee discretion),
• a medical condition that could be expected to interfere with the subject's safety during the study period, such as a true allergy to oral care product ingredients, including (but not limited to) artificial sweeteners, mint (peppermint, spearmint, etc.) or other artificial colors or flavorings, sodium fluoride, ingredients that are derived from seaweed or corn, etc.,
• full dentures, orthodontic appliances (with the exception of a lower, fixed retainer), or other oral devices/appliances or dental work which, at the discretion of the Investigator/Designee, would interfere with the fit of the dental appliance,
• self-reported pregnancy, plans to become pregnant, or is currently breastfeeding,
• allergy/adverse reaction to dental impression materials including Silicon Dioxide, Calcium Sulfate, Magnesium Oxide or Tetrasodium Pyrophosphate,
• any decayed, untreated dental sites (cavities) (per Investigator/Designee discretion),
• having taken antibiotic or immune-suppressive drugs within the past 30 days or anticipating the need to take antibiotic or immune-suppressive drugs during the course of the study (per Investigator/Designee discretion),
• a medical history disclosing a medical condition that has been known to cause individuals to become severely immuno-compromised, or
• a medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc. (per Investigator/Designee discretion).

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead
• Therametrics: collaborator

Study Sites (1)

Therametric Technologies, Inc.

Noblesville, Indiana, 46060, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Annahita Ghassemi, PhD

  Church & Dwight, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 19, 2026
• Study Start: August 12, 2024
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)