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The purpose of this study is to investigate the ability of an experimental dentifrice containing 1150 parts per million (ppm) fluoride to remineralize acid-softened dental enamel and help prevent further demineralization compared to a 0 ppm fluoride placebo dentifrice and a marketed, fluoride-containing dentifrice (Reference Dentifrice).
This will be a randomized, controlled, single center, single-blind, 3 period, 3 treatment, cross-over, in situ design study. Previously demineralized bovine enamel specimens will be placed intra orally using a palatal appliance and the remineralizing performance of the experimental, reference and placebo dentifrices will be evaluated at 4 and 12 hours post toothbrushing, based on surface micro hardness measurements of the bovine enamel specimens. At each treatment visit, once the palatal the appliance is fitted in the mouth, a five minute equilibration period will ensue following which each participant will brush their teeth with their assigned product. Participants will remove the appliance for 30 minutes at 4 and 8.5 hours post brushing and will remove and store the appliance 13 hours post brushing (12 hours intraoral exposure). Sufficient participants will be screened to randomize approximately 33 participants to study treatment to ensure approximately 30 participants complete the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Dentifrice | Experimental | Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 grams (g) of the experimental dentifrice containing 1150 ppm fluoride and 5 percent (%) potassium nitrate (KNO3) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days. |
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| Placebo Control Dentifrice | Placebo Comparator | Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the placebo dentifrice containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days. |
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| Reference Dentifrice | Active Comparator | Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the reference dentifrice containing 1100 ppm fluoride as stannous fluoride (SnF2) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Dentifrice | Drug | Dentifrice containing 1150 ppm fluoride and 5% KNO3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Percent Surface Microhardness Recovery (%SMHR) at 4 Hours (Test Dentifrice Versus (vs.) Placebo Control Dentifrice) | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface microhardness (SMH) technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (micrometre [μm]) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization. | At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Percent Relative Erosion Resistance (%RER) at 4 Hours (Test Dentifrice vs. Placebo Control Dentifrice) | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). |
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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 18-65 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 with generally good oral health that fulfil all of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Health Research Institute | Indianapolis | Indiana | 46202 | United States |
Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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.
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.
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A total of 34 participants were screened of which 33 participants were randomized as per crossover design to receive either one of the 6 treatment sequences: Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA where Treatment A=Test Dentifrice, Treatment B=Placebo Control Dentifrice, Treatment C=Reference Dentifrice. All 33 randomized participants completed the study.
This study was conducted at a single center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence ABC (Test Dentifrice + Placebo Control Dentifrice + Reference Dentifrice) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 grams (g) of the Test Dentifrice containing 1150 parts per million (ppm) fluoride and 5 percent (%) potassium nitrate (KNO3) once on Day 1 of Treatment Period 1 (Treatment A) followed by 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment B) and further followed by 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as stannous fluoride (SnF2) once on Day 1 of Treatment Period 3 (Treatment C). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment. |
| FG001 | Sequence ACB (Test Dentifrice + Reference Dentifrice + Placebo Control Dentifrice) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of the Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 1 (Treatment A) followed by 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 2 (Treatment C) and further followed by 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment B). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment. |
| FG002 | Sequence BAC (Placebo Control Dentifrice + Test Dentifrice + Reference Dentifrice) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 1 (Treatment B) followed by 1.5+/-0.1 g of the Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment A) and further followed by 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 3 (Treatment C). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment. |
| FG003 | Sequence BCA (Placebo Control Dentifrice + Reference Dentifrice + Test Dentifrice) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 1 (Treatment B) followed by 1.5+/-0.1 g of the Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 2 (Treatment C) and further followed by 1.5+/-0.1 g of Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment A). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment. |
| FG004 | Sequence CAB (Reference Dentifrice + Test Dentifrice + Placebo Control Dentifrice) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 1 (Treatment C) followed by 1.5+/-0.1 g of the Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment A) and further followed by 1.5+/-0.1 g of Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment B). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment. |
| FG005 | Sequence CBA (Reference Dentifrice + Placebo Control Dentifrice + Test Dentifrice) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of Reference Dentifrice containing 1100 ppm fluoride as SnF2 once on Day 1 of Treatment Period 1 (Treatment C) followed by 1.5+/-0.1 g of the Placebo Control Dentifrice containing 0 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 2 (Treatment B) and further followed by 1.5+/-0.1 g of Test Dentifrice containing 1150 ppm fluoride and 5% KNO3 once on Day 1 of Treatment Period 3 (Treatment A). Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. There was a washout period of a minimum of 3 days prior to each treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (2 Days) |
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| Washout Period (3 Days) |
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| Treatment Period 2 (2 Days) |
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| Washout Period (3 Days) |
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| Treatment Period 3 (2 Days) |
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Intent-to-Treat (ITT) population included all participants who were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | Participants brushed the buccal surfaces of their natural teeth using 1.5+/-0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3, Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3, Reference Dentifrice (Treatment C) containing 1100 ppm fluoride as SnF2 on Day 1 of Treatment Period 1, 2 or 3 as per randomization schedule. Participants used the assigned dentifrice under supervision of the study staff while the intraoral appliance was in place and brushed the buccal surfaces of their natural teeth for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adjusted Mean Percent Surface Microhardness Recovery (%SMHR) at 4 Hours (Test Dentifrice Versus (vs.) Placebo Control Dentifrice) | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface microhardness (SMH) technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (micrometre [μm]) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization. | ITT population included all participants who were randomized. | Posted | Least Squares Mean | Standard Error | percent SMHR | At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product. A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Dentifrice (Treatment A) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Test Dentifrice (Treatment A) containing 1150 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulpitis irreversible | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haleon Response Center | HALEON | +441932959500 | ww.clinical-trial-register@haleon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2024 | Apr 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2024 | Apr 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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| Placebo Control Dentifrice | Drug | Dentifrice containing 0 ppm fluoride and 5% KNO3. |
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| Reference Dentifrice | Drug | Dentifrice containing 1100 ppm fluoride as SnF2. |
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| At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean %SMHR at 4 Hours (Test Dentifrice vs. Reference Dentifrice) | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization. | At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean %SMHR at 12 Hours | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 12 hours in situ remineralization. | At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean %RER at 4 Hours (Test Dentifrice vs. Reference Dentifrice) | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). | At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean %RER at 12 Hours | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). | At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean Enamel Fluoride Uptake (EFU) at 4 and 12 Hours | EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment. | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean Acid Resistance Ratio (ARR) at 4 and 12 Hours | ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate ARR. The ARR was derived as 1 - [(E2-R)/(E1-B)] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization. | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean %SMHR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatment in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization. | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean %RER at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean EFU at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment. | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
| Adjusted Mean ARR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to yield ARR. The ARR was derived as 1 - [(E2-R)/(E1-B)] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization. | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Adjusted Mean Percent Relative Erosion Resistance (%RER) at 4 Hours (Test Dentifrice vs. Placebo Control Dentifrice) | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). | ITT population. | Posted | Least Squares Mean | Standard Error | percent RER | At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean %SMHR at 4 Hours (Test Dentifrice vs. Reference Dentifrice) | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using surface SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 hours in situ remineralization. | ITT population. | Posted | Least Squares Mean | Standard Error | percent SMHR | At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean %SMHR at 12 Hours | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 12 hours in situ remineralization. | ITT population. | Posted | Least Squares Mean | Standard Error | percent SMHR | At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean %RER at 4 Hours (Test Dentifrice vs. Reference Dentifrice) | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). | ITT population. | Posted | Least Squares Mean | Standard Error | percent RER | At 4 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean %RER at 12 Hours | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). | ITT population. | Posted | Least Squares Mean | Standard Error | percent RER | At 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean Enamel Fluoride Uptake (EFU) at 4 and 12 Hours | EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment. | ITT population. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | microgram fluoride per square centimeter | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean Acid Resistance Ratio (ARR) at 4 and 12 Hours | ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate ARR. The ARR was derived as 1 - [(E2-R)/(E1-B)] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization. | ITT population. | Posted | Least Squares Mean | Standard Error | ratio | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean %SMHR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | %SMHR was used to measure the ability of the dentifrice to remineralize enamel. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatment in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and the extent of remineralization was evaluated using SMH technique to yield the %SMHR. The enamel specimens were evaluated both prior to and after intra-oral exposure and indentation lengths were measured. The %SMHR was derived as [(E1-R)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization. | ITT population. | Posted | Least Squares Mean | Standard Error | percent SMHR | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean %RER at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | %RER was used to measure the ability of the dentifrice to protect enamel from further acid-induced demineralization by both acid protection and remineralization. SMH technique was used to calculate %RER. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to calculate %RER. The %RER was derived as [(E1-E2)/(E1-B)] * 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice). | ITT population. | Posted | Least Squares Mean | Standard Error | percent RER | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean EFU at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | EFU is a measure of how much fluoride has been incorporated into the enamel during the process of remineralization. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and chemically analyzed to measure the amount of fluoride incorporated into the enamel by the dentifrice treatment. | ITT population. | Posted | Geometric Least Squares Mean | 95% Confidence Interval | microgram fluoride per square centimeter | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| Secondary | Adjusted Mean ARR at 4 and 12 Hours (Reference Dentifrice vs Placebo Control Dentifrice) | ARR was used to measure the resistance of the remineralized enamel to further acid softening. SMH technique was used to calculate ARR. Previously demineralized, sterilized bovine enamel specimens were placed intra orally using a palatal appliance. The enamel specimens were exposed to the dentifrice treatments in the mouth during the treatment application and allowed to remineralize intra orally under the action of the participant's saliva. The specimens were then removed from the palatal appliance and further treated with acid ex situ followed by additional SMH evaluations to yield ARR. The ARR was derived as 1 - [(E2-R)/(E1-B)] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge (with a commercially available grapefruit juice), E2 = indentation length (μm) after second erosive challenge (with a commercially available grapefruit juice), R = indentation length (μm) after 4 and 12 hours in situ remineralization. | ITT population. | Posted | Least Squares Mean | Standard Error | ratio | At 4 and 12 hours of intra-oral exposure following treatment on Day 1 of each treatment period (each treatment period was of 2 days with 3 days washout in between) |
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| 0 |
| 33 |
| 0 |
| 33 |
| 4 |
| 33 |
| EG001 | Reference Dentifrice (Treatment C) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Reference Dentifrice (Treatment C) containing 1100 ppm fluoride as SnF2 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place. | 0 | 33 | 0 | 33 | 1 | 33 |
| EG002 | Placebo Control Dentifrice (Treatment B) | Participants brushed the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the Placebo Control Dentifrice (Treatment B) containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swished the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds, once on Day 1 of Treatment Periods 1 to 3 as per randomization schedule. Participants used the dentifrice under supervision of the study staff while the intraoral appliance was in place. | 0 | 33 | 0 | 33 | 5 | 33 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anxiety worsening | Psychiatric disorders | Systematic Assessment |
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| Bell's palsy | Nervous system disorders | Systematic Assessment |
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| Back Pain, Worsening | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Trigger Finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| At 12 hours of intra-oral exposure |
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At 12 hours of intra-oral exposure |
| Mixed Models Analysis |
| 0.2178 |
| Adjusted Mean Difference |
| 3.00 |
| Standard Error of the Mean |
| 2.408 |
| 2-Sided |
| 95 |
| -1.82 |
| 7.81 |
Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice. |
| Superiority |
At 12 hours of intra-oral exposure |
| Mixed Models Analysis |
| <.0001 |
| Adjusted Mean Difference |
| 27.18 |
| Standard Error of the Mean |
| 3.018 |
| 2-Sided |
| 95 |
| 21.14 |
| 33.21 |
Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice. |
| Superiority |
| <.0001 |
| Geometric Mean Ratio |
| 1.59 |
| 2-Sided |
| 95 |
| 1.42 |
| 1.78 |
| Superiority |
At 12 hours of intra-oral exposure |
| Mixed Models Analysis |
| <.0001 |
| Adjusted Mean Difference |
| 0.242 |
| Standard Error of the Mean |
| 0.0257 |
| 2-Sided |
| 95 |
| 0.190 |
| 0.293 |
Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice. |
| Superiority |