An interventional study of Experimental Dentifrice and Placebo Control Dentifrice in Tooth Erosion, sponsored by HALEON. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by HALEON · Not applicable, Interventional, and Treatment
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.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 33 is close to the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →HALEON is the lead sponsor of 64 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant with generally good oral health that fulfil all of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Experimental Dentifrice
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.
Drug: Placebo Control Dentifrice
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.
Drug: Reference Dentifrice
Dentifrice containing 1150 ppm fluoride and 5% KNO3.
Dentifrice containing 0 ppm fluoride and 5% KNO3.
Dentifrice containing 1100 ppm fluoride as SnF2.
Also known as: Crest Pro-Health Densify Daily Protection
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.
Time frame: 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 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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)
This study was conducted at a single center in the United States.
| Milestone | Sequence ABC (Test Dentifrice + Placebo Control Dentifrice + Reference Dentifrice) | Sequence ACB (Test Dentifrice + Reference Dentifrice + Placebo Control Dentifrice) | Sequence BAC (Placebo Control Dentifrice + Test Dentifrice + Reference Dentifrice) | Sequence BCA (Placebo Control Dentifrice + Reference Dentifrice + Test Dentifrice) | Sequence CAB (Reference Dentifrice + Test Dentifrice + Placebo Control Dentifrice) | Sequence CBA (Reference Dentifrice + Placebo Control Dentifrice + Test Dentifrice) |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 6 | 6 | 5 | 6 |
| Completed | 5 | 5 | 6 | 6 | 5 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence ABC (Test Dentifrice + Placebo Control Dentifrice + Reference Dentifrice) | Sequence ACB (Test Dentifrice + Reference Dentifrice + Placebo Control Dentifrice) | Sequence BAC (Placebo Control Dentifrice + Test Dentifrice + Reference Dentifrice) | Sequence BCA (Placebo Control Dentifrice + Reference Dentifrice + Test Dentifrice) | Sequence CAB (Reference Dentifrice + Test Dentifrice + Placebo Control Dentifrice) | Sequence CBA (Reference Dentifrice + Placebo Control Dentifrice + Test Dentifrice) |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 6 | 6 | 5 | 6 |
| Completed | 5 | 5 | 6 | 6 | 5 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence ABC (Test Dentifrice + Placebo Control Dentifrice + Reference Dentifrice) | Sequence ACB (Test Dentifrice + Reference Dentifrice + Placebo Control Dentifrice) | Sequence BAC (Placebo Control Dentifrice + Test Dentifrice + Reference Dentifrice) | Sequence BCA (Placebo Control Dentifrice + Reference Dentifrice + Test Dentifrice) | Sequence CAB (Reference Dentifrice + Test Dentifrice + Placebo Control Dentifrice) | Sequence CBA (Reference Dentifrice + Placebo Control Dentifrice + Test Dentifrice) |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 6 | 6 | 5 | 6 |
| Completed | 5 | 5 | 6 | 6 | 5 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence ABC (Test Dentifrice + Placebo Control Dentifrice + Reference Dentifrice) | Sequence ACB (Test Dentifrice + Reference Dentifrice + Placebo Control Dentifrice) | Sequence BAC (Placebo Control Dentifrice + Test Dentifrice + Reference Dentifrice) | Sequence BCA (Placebo Control Dentifrice + Reference Dentifrice + Test Dentifrice) | Sequence CAB (Reference Dentifrice + Test Dentifrice + Placebo Control Dentifrice) | Sequence CBA (Reference Dentifrice + Placebo Control Dentifrice + Test Dentifrice) |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 6 | 6 | 5 | 6 |
| Completed | 5 | 5 | 6 | 6 | 5 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence ABC (Test Dentifrice + Placebo Control Dentifrice + Reference Dentifrice) | Sequence ACB (Test Dentifrice + Reference Dentifrice + Placebo Control Dentifrice) | Sequence BAC (Placebo Control Dentifrice + Test Dentifrice + Reference Dentifrice) | Sequence BCA (Placebo Control Dentifrice + Reference Dentifrice + Test Dentifrice) | Sequence CAB (Reference Dentifrice + Test Dentifrice + Placebo Control Dentifrice) | Sequence CBA (Reference Dentifrice + Placebo Control Dentifrice + Test Dentifrice) |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 6 | 6 | 5 | 6 |
| Completed | 5 | 5 | 6 | 6 | 5 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
%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.
| percent SMHR | Test Dentifrice (Treatment A) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|
| Adjusted Mean Percent Surface Microhardness Recovery (%SMHR) at 4 Hours (Test Dentifrice Versus (vs.) Placebo Control Dentifrice) | 32.20 ± 2.021 | 23.85 ± 2.021 |
%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).
| percent RER | Test Dentifrice (Treatment A) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|
| Adjusted Mean Percent Relative Erosion Resistance (%RER) at 4 Hours (Test Dentifrice vs. Placebo Control Dentifrice) | -11.56 ± 3.024 | -48.89 ± 3.024 |
%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.
| percent SMHR | Test Dentifrice (Treatment A) | Reference Dentifrice (Treatment C) |
|---|---|---|
| Adjusted Mean %SMHR at 4 Hours (Test Dentifrice vs. Reference Dentifrice) | 32.20 ± 2.021 | 28.25 ± 2.019 |
%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.
| percent SMHR | Test Dentifrice (Treatment A) | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|---|
| Adjusted Mean %SMHR at 12 Hours | 39.32 ± 1.826 | 36.66 ± 1.824 | 33.66 ± 1.826 |
%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).
| percent RER | Test Dentifrice (Treatment A) | Reference Dentifrice (Treatment C) |
|---|---|---|
| Adjusted Mean %RER at 4 Hours (Test Dentifrice vs. Reference Dentifrice) | -11.56 ± 3.024 | -13.78 ± 3.022 |
%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).
| percent RER | Test Dentifrice (Treatment A) | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|---|
| Adjusted Mean %RER at 12 Hours | -0.28 ± 2.760 | 0.19 ± 2.759 | -26.98 ± 2.760 |
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.
| microgram fluoride per square centimeter | Test Dentifrice (Treatment A) | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|---|
| At 4 hours of intra-oral exposure | 4.80 (4.31 to 5.35) | 3.81 (3.42 to 4.25) | 2.20 (1.98 to 2.45) |
| At 12 hours of intra-oral exposure | 4.80 (4.41 to 5.22) | 3.89 (3.58 to 4.24) | 2.45 (2.25 to 2.66) |
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.
| ratio | Test Dentifrice (Treatment A) | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|---|
| At 4 hours of intra-oral exposure | 0.562 ± 0.0214 | 0.580 ± 0.0214 | 0.273 ± 0.0214 |
| At 12 hours of intra-oral exposure | 0.604 ± 0.0200 | 0.635 ± 0.0200 | 0.394 ± 0.0200 |
%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.
| percent SMHR | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|
| At 4 hours of intra-oral exposure | 28.25 ± 2.019 | 23.85 ± 2.021 |
| At 12 hours of intra-oral exposure | 36.66 ± 1.824 | 33.66 ± 1.826 |
%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).
| percent RER | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|
| At 4 hours of intra-oral exposure | -13.78 ± 3.022 | -48.89 ± 3.024 |
| At 12 hours of intra-oral exposure | 0.19 ± 2.759 | -26.98 ± 2.760 |
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.
| microgram fluoride per square centimeter | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|
| At 4 hours of intra-oral exposure | 3.81 (3.42 to 4.25) | 2.20 (1.98 to 2.45) |
| At 12 hours of intra-oral exposure | 3.89 (3.58 to 4.24) | 2.45 (2.25 to 2.66) |
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.
| ratio | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|
| At 4 hours of intra-oral exposure | 0.580 ± 0.0214 | 0.273 ± 0.0214 |
| At 12 hours of intra-oral exposure | 0.635 ± 0.0200 | 0.394 ± 0.0200 |
Collected over From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 21 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Dentifrice (Treatment A) | 0/33 (0%) | 0/33 (0%) | 4/33 (12.1%) |
| Reference Dentifrice (Treatment C) | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) |
| Placebo Control Dentifrice (Treatment B) | 0/33 (0%) | 0/33 (0%) | 5/33 (15.2%) |
| Event | Test Dentifrice (Treatment A) | Reference Dentifrice (Treatment C) | Placebo Control Dentifrice (Treatment B) |
|---|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 0/33 | 0/33 | 4/33 |
| Pulpitis irreversibleGastrointestinal disorders | 0/33 | 0/33 | 1/33 |
| Anxiety worseningPsychiatric disorders | 1/33 | 0/33 | 0/33 |
| Bell's palsyNervous system disorders | 1/33 | 0/33 | 0/33 |
| Back Pain, WorseningMusculoskeletal and connective tissue disorders | 1/33 | 0/33 | 0/33 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 0/33 | 1/33 | 0/33 |
| Trigger FingerMusculoskeletal and connective tissue disorders | 1/33 | 0/33 | 0/33 |
Intent-to-Treat (ITT) population included all participants who were randomized in the study.
| Age, Continuous(years) | Overall Study Participants |
|---|---|
| Mean | 50.7 ± 10.5 |
| Sex: Female, Male(Participants) | Overall Study Participants |
|---|---|
| Female | 25 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Overall Study Participants |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 27 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Overall Study Participants |
|---|---|
| Asian | 4 |
| Black or African American | 9 |
| White | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
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.
Ran from Feb 2024 to primary completion in May 2024, 2 months.
Results were first posted in May 2025, 1 year after primary completion.
Of 20 interventional studies with no phase under Tooth Erosion, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 28. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
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