Dental CariesNCT06949072
A Clinical Study to Assess an Experimental Dentifrice in an Experimental Model of Early Stage Caries
A study testing Test Dentifrice and Reference Dentifrice in people with Dental Caries, run by HALEON at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Test Dentifrice and Reference Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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).
- Willing to have their denture modified to accommodate the enamel test specimens.
- Willing and capable of wearing their removable partial dentures 24 hours per day during each 14-day treatment period.
- Willing and capable of brushing their natural teeth with the lower partial denture in place.
- 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).
Who cannot join
- 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.
Show all 16Show fewer
- 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:
- Taking antibiotics or has taken antibiotics in the two weeks prior to the screening visit.
- Taking or has ever taken a bisphosphonate drug (that is, Fosamax, Actonel Boniva, Reclast, or Zometa).
- 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:
- Dental restorations in a poor state of repair that could impact participant safety or efficacy evaluations.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Institute
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Test Dentifrice, Reference Dentifrice, Negative Control Dentifrice
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test DentifriceDrug
Dentifrice containing 5 percent (%) weight by weight (w/w) Potassium nitrate (KNO3) and 1150ppm fluoride as sodium fluoride.
Reference DentifriceDrug
Dentifrice containing 1100ppm fluoride as stannous fluoride.
Negative Control DentifriceDrug
Dentifrice containing 5% KNO3 with no fluoride.
| Study group | Role | What they receive |
|---|---|---|
| Test Dentifrice | Experimental | 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. Receives: Drug: Test Dentifrice |
| Reference Dentifrice | Active comparator | 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. Receives: Drug: Reference Dentifrice |
| Negative Control Dentifrice | Active comparator | 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. Receives: Drug: Negative Control Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Surface Microhardness Recovery (%SMHr) After 2 Weeks in situ (Experimental Dentifrice Versus [Vs] Negative Control Dentifrice)
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.
Measured: After 2 Weeks in situ in each Treatment Period
Secondary outcomes (8)
%SMHr After 2 Weeks in situ (Experimental Dentifrice Vs Reference Dentifrice)
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.
Measured: After 2 Weeks in situ in each Treatment Period
%SMHr After 2 Weeks in situ (Reference Dentifrice Vs Negative Control Dentifrice)
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.
Measured: After 2 Weeks in situ in each Treatment Period
Transverse Microradiography (TMR) Parameter - Integrated Mineral Loss (∆Z) After 2 Weeks in situ
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.
Measured: After 2 Weeks in situ in each Treatment Period
TMR Parameter - Lesion Depth (L) After 2 Weeks in situ
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.
Measured: After 2 Weeks in situ in each Treatment Period
TMR Parameter - Maximum Mineral Density at the Surface Zone (SZmax) After 2 Weeks in situ
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.
Measured: After 2 Weeks in situ in each Treatment Period
Enamel Fluoride Uptake (EFU) After 2 Weeks in situ
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.
Measured: After 2 Weeks in situ in each Treatment Period
Percent Net Acid Resistance (%NAR) After 2 Weeks in situ and Further in vitro Demineralization
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.
Measured: After 2 Weeks in situ in each Treatment Period
Acid Resistance Ratio (ARR) After 2 Weeks in situ and Further in vitro Demineralization
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.
Measured: After 2 Weeks in situ in each Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start28 Apr 2025
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by HALEONThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949072
- Sponsor's protocol ID
- 300267
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Cross-Over Clinical Study to Assess an Experimental Dentifrice in an in Situ Model of Early Stage Caries
- ClinicalTrials.gov ID
- NCT06949072
- Acronym / sponsor ID
- 300267
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Dentifrice | Experimental | Drug: Test DentifriceParticipants 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. |
| Reference Dentifrice | Active comparator | Drug: Reference DentifriceParticipants 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. |
| Negative Control Dentifrice | Active comparator | Drug: Negative Control DentifriceParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test DentifriceDentifrice containing 5 percent (%) weight by weight (w/w) Potassium nitrate (KNO3) and 1150ppm fluoride as sodium fluoride. | Drug | Test Dentifrice |
| Reference DentifriceDentifrice containing 1100ppm fluoride as stannous fluoride. | Drug | Reference Dentifrice |
| Negative Control DentifriceDentifrice containing 5% KNO3 with no fluoride. | Drug | Negative Control Dentifrice |
Primary outcome
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.
8 secondary outcomes
%SMHr After 2 Weeks in situ (Experimental Dentifrice Vs Reference Dentifrice)
Time frame: 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
Transverse Microradiography (TMR) Parameter - Integrated Mineral Loss (∆Z) After 2 Weeks in situ
Time frame: 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
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
Enamel Fluoride Uptake (EFU) After 2 Weeks in situ
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Dentifrice and Reference Dentifrice in people with Dental Caries, run by HALEON at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.