A Clinical Study to Assess an Experimental Dentifrice in an Experimental Model of Early Stage Caries

September 23, 2025 updated by: HALEON

A Randomized, Single-Blind, Cross-Over Clinical Study to Assess an Experimental Dentifrice in an in Situ Model of Early Stage Caries

The aim of this study is to evaluate the relative efficacy of an experimental dentifrice containing 1150 parts per million (ppm) fluoride (as sodium fluoride [NaF]) to remineralize early stage caries type lesions in an in situ model compared to a negative control and a reference dentifrice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, single-blind, single-center, controlled, three period, three treatment, cross-over caries in situ model in healthy participants who wear a suitable removable mandibular partial denture. The denture will be modified to accommodate 2 gauze-covered, 4 millimeter (mm) round specimens of bovine dental enamel that have been previously demineralized in vitro to form artificial caries lesions. After 14 days of twice daily product use off-site, the specimens will be removed at the study site to determine the remineralization ability of the treatments. The same procedure will be followed for period 2 and 3 with a washout period of 2-3 days prior to each treatment period. Sufficient participants will be screened to randomize up to 50 participants to the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Oral Health Research Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-85 years, inclusive.
  • Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.
  • Participant is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
  • Participant who demonstrates a salivary flow-rate in the range of normal values (unstimulated whole saliva flow-rate more than or equal to (>=) 0.2 grams per minute (g/min); gum base stimulated whole saliva flow-Rate >= 0.8 g/min).

  • Participant with a removable partial denture (RPD) fulfilling:

    1. Wears a removable mandibular partial denture that has good stability and support, with sufficient room on one side in the posterior teeth/buccal flange area to accommodate two enamel specimens (required dimensions approximately 5mm in diameter and 2.5mm deep for each specimen site).
    2. Willing to have their denture modified to accommodate the enamel test specimens.
    3. Willing and capable of wearing their removable partial dentures 24 hours per day during each 14-day treatment period.
    4. Willing and capable of brushing their natural teeth with the lower partial denture in place.
    5. Willing to cease using all denture cleaners and fixatives on their mandibular RPD during the study (with the exception of the supplied non-zinc fixative which may be used on any maxillary denture if present and required).

Exclusion Criteria:

  • Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
  • Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
  • Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • Participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
  • Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Participant who, in the opinion of the investigator or medically qualified designee, has a condition or medical history that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements or who should not participate in the study for other reasons.
  • Participant with a recent history (within the last year) of alcohol or other substance abuse.
  • Participant requiring the need for antibiotic premedication prior to a dental prophylaxis or taking some blood thinning medications that prohibit the safe conduct of a dental cleaning. Note: Medical consultation may need to be obtained from participant's physician at the examiner's discretion.

  • Participant who is:

    1. Taking antibiotics or has taken antibiotics in the two weeks prior to the screening visit.
    2. Taking or has ever taken a bisphosphonate drug (that is, Fosamax, Actonel Boniva, Reclast, or Zometa).
    3. Using or intending to use professionally recommended fluoride supplements or fluoride mouth rinse, or has received a professional fluoride application in the 2 weeks prior to screening.

  • Participant who has:

    1. Dental restorations in a poor state of repair that could impact participant safety or efficacy evaluations.
    2. Active caries or moderate or severe periodontal disease that may compromise the study or health of the participant. Participants presenting at screening with minor caries may continue in the study if their carious lesions are repaired prior to the start of the first treatment period.
  • Participant who has previously been enrolled in this study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Dentifrice
Participants will be instructed to dose the toothbrush provided with a strip of test dentifrice (a full brush head) and brush for one timed minute, twice daily (morning and evening) per the Brushing Instructions for up to 14 days each in Treatment Periods 1 to 3 as per crossover assignment. There will be a washout period of 2-3 days prior to each treatment period during which the participants will brush their teeth with the washout dentifrice for one timed minute, twice daily (morning and evening) per the Brushing Instructions.
Drug: Test Dentifrice
Dentifrice containing 5 percent (%) weight by weight (w/w) Potassium nitrate (KNO3) and 1150ppm fluoride as sodium fluoride.
Active Comparator: Reference Dentifrice
Participants will be instructed to dose the toothbrush provided with a strip of reference dentifrice (a full brush head) and brush for one timed minute, twice daily (morning and evening) per the Brushing Instructions for up to 14 days each in Treatment Periods 1 to 3 as per crossover assignment. There will be a washout period of 2-3 days prior to each treatment period during which the participants will brush their teeth with the washout dentifrice for one timed minute, twice daily (morning and evening) per the Brushing Instructions.
Drug: Reference Dentifrice
Dentifrice containing 1100ppm fluoride as stannous fluoride.
Active Comparator: Negative Control Dentifrice
Participants will be instructed to dose the toothbrush provided with a strip of negative control dentifrice (a full brush head) and brush for one timed minute, twice daily (morning and evening) per the Brushing Instructions for up to 14 days each in Treatment Periods 1 to 3 as per crossover assignment. There will be a washout period of 2-3 days prior to each treatment period during which the participants will brush their teeth with the washout dentifrice for one timed minute, twice daily (morning and evening) per the Brushing Instructions.
Drug: Negative Control Dentifrice
Dentifrice containing 5% KNO3 with no fluoride.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Surface Microhardness Recovery (%SMHr) After 2 Weeks in situ (Experimental Dentifrice Versus [Vs] Negative Control Dentifrice)
Time Frame: After 2 Weeks in situ in each Treatment Period
The Surface Microhardness (SMH) technique is used to detect changes in the mineral content of dental enamel. The %SMHr will be derived as [(D1-R)/(D1-B)]*100, where D1= mean of replicate indentation lengths (micrometer [μm]) in enamel after first in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
After 2 Weeks in situ in each Treatment Period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
%SMHr After 2 Weeks in situ (Experimental Dentifrice Vs Reference Dentifrice)
Time Frame: After 2 Weeks in situ in each Treatment Period
The SMH technique is used to detect changes in the mineral content of dental enamel. The %SMHr will be derived as [(D1-R)/(D1-B)]*100, where D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
After 2 Weeks in situ in each Treatment Period
%SMHr After 2 Weeks in situ (Reference Dentifrice Vs Negative Control Dentifrice)
Time Frame: After 2 Weeks in situ in each Treatment Period
The SMH technique is used to detect changes in the mineral content of dental enamel. The %SMHr will be derived as [(D1-R)/(D1-B)]*100, where D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
After 2 Weeks in situ in each Treatment Period
Transverse Microradiography (TMR) Parameter - Integrated Mineral Loss (∆Z) After 2 Weeks in situ
Time Frame: After 2 Weeks in situ in each Treatment Period
Integrated Mineral Loss will be determined using TMR. TMR measures changes in mineral content by cutting the enamel specimens into plano-parallel thin slices and taking digitized microradiographic images of each. The mineral content is calculated from the gray intensity levels of the images of section.
After 2 Weeks in situ in each Treatment Period
TMR Parameter - Lesion Depth (L) After 2 Weeks in situ
Time Frame: After 2 Weeks in situ in each Treatment Period
Lesion depth will be determined using TMR. TMR measures changes in mineral content by cutting the enamel specimens into plano-parallel thin slices and taking digitized microradiographic images of each. The mineral content is calculated from the gray intensity levels of the images of section.
After 2 Weeks in situ in each Treatment Period
TMR Parameter - Maximum Mineral Density at the Surface Zone (SZmax) After 2 Weeks in situ
Time Frame: After 2 Weeks in situ in each Treatment Period
Maximum mineral density at the surface zone will be determined using TMR. TMR measures changes in mineral content by cutting the enamel specimens into plano-parallel thin slices and taking digitized microradiographic images of each. The mineral content is calculated from the gray intensity levels of the images of section.
After 2 Weeks in situ in each Treatment Period
Enamel Fluoride Uptake (EFU) After 2 Weeks in situ
Time Frame: After 2 Weeks in situ in each Treatment Period
EFU gives valuable information regarding how much fluoride is incorporated into a remineralized lesion. In this technique the enamel is sampled through use of a microdrill to obtain a quantity of powdered enamel representative of the cross section through the lesion. The powder is dissolved in acid and chemically analyzed for fluoride.
After 2 Weeks in situ in each Treatment Period
Percent Net Acid Resistance (%NAR) After 2 Weeks in situ and Further in vitro Demineralization
Time Frame: After 2 Weeks in situ in each Treatment Period
The resistance to acid-induced demineralization will be assessed through NAR. The %NAR (at the specimen level) will be derived as [(D1-D2)/(D1-B)]*100, where D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization, D2= mean of replicate indentation lengths (μm) in enamel after the second in vitro demineralization and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
After 2 Weeks in situ in each Treatment Period
Acid Resistance Ratio (ARR) After 2 Weeks in situ and Further in vitro Demineralization
Time Frame: After 2 Weeks in situ in each Treatment Period
The resistance to acid-induced demineralization will be assessed through ARR. The ARR will be derived as 1-[(D2-R)/(D1-B)] where, D2= mean of replicate indentation lengths (μm) in enamel after the second in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ, D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
After 2 Weeks in situ in each Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HALEON

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 300267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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