A Phase 3 interventional study of 0.254% w/w sodium fluoride and 5% KNO3 and 0.454% w/w stannous fluoride in Tooth Erosion, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent weight by weight [%, w/w] sodium fluoride (1150 parts per million [ppm] fluoride) and 5% KNO3 [potassium nitrate]), comparator (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride free placebo containing 5% KNO3 [0 ppm fluoride] ) dentifrices 2 and 4 hours (hrs) post treatment application, based on surface micro hardness measurements. This study will be carried out in healthy adults with a maxillary dental arch suitable for the retention of the palatal appliance.
The aim of this study is to investigate the performance of an experimental dentifrice formulation in promoting enamel remineralization and inhibiting post-treatment enamel demineralization in an in situ erosion model, in comparison with a fluoride-free placebo and with a marketed competitor dentifrice product. The study will have 4 visits, 1 screening visit to assess participants eligibility and 3 treatment visits to assess product efficacy, where the treatment product will be dispensed and used under the supervision of a suitably trained study site personnel. Prior to each treatment visit, there will be a washout period of a minimum of 3 days. During this period participants will use their own dentifrice for at least one day, and a fluoride free dentifrice (provided) for two days prior to the next scheduled visit (including in the morning of the scheduled visit) to minimize any carry-over effects of the fluoride toothpaste.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 62 is above the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) 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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 apply a full ribbon of the test product (1.5 grams \[g\]) containing 0.254% w/w sodium fluoride and 5% KNO3.
Drug: 0.254% w/w sodium fluoride and 5% KNO3
Participants will apply a full ribbon of the comparator product (1.5 g orally) containing 0.454% w/w stannous fluoride.
Drug: 0.454% w/w stannous fluoride
Participants will apply a full ribbon of the placebo (1.5 g orally) containing 5% KNO3.
Drug: 5% KNO3
Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres \[mL\] of tap water for 10 seconds before expectorating again.
Dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = \[(E1-R)/(E1-B)\]\*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
Time frame: After 4 hrs following single exposure of treatment
% Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel)
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = \[(E1-E2)/ (E1-B)\]\*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
Time frame: After 4 hrs following single exposure of treatment
Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel)
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm\^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
Time frame: After 4 hrs following single exposure of treatment
% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as: %SMHR = \[(E1-R)/(E1-B)\]\*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
Time frame: After 4 hrs following single exposure of treatment
% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = \[(E1-E2)/ (E1-B)\]\*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
Time frame: After 4 hrs following single exposure of treatment
EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm\^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
Time frame: After 4 hrs following single exposure of treatment
Participants were recruited from one center in United States of America.
| Milestone | Test Product/Comparator Product/Placebo Product | Test Product/Placebo Product/Comparator Product | Comparator Product/Test Product/Placebo Product | Comparator Product/Placebo Product/ Test Product | Placebo Product/Test Product/Comparator Product | Placebo Product/Comparator Product/Test Product |
|---|---|---|---|---|---|---|
| Started | 10 | 11 | 10 | 10 | 10 | 11 |
| Completed | 10 | 11 | 10 | 10 | 10 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Test Product/Comparator Product/Placebo Product | Test Product/Placebo Product/Comparator Product | Comparator Product/Test Product/Placebo Product | Comparator Product/Placebo Product/ Test Product | Placebo Product/Test Product/Comparator Product | Placebo Product/Comparator Product/Test Product |
|---|---|---|---|---|---|---|
| Started | 10 | 11 | 10 | 10 | 10 | 11 |
| Completed | 10 | 11 | 10 | 10 | 10 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Test Product/Comparator Product/Placebo Product | Test Product/Placebo Product/Comparator Product | Comparator Product/Test Product/Placebo Product | Comparator Product/Placebo Product/ Test Product | Placebo Product/Test Product/Comparator Product | Placebo Product/Comparator Product/Test Product |
|---|---|---|---|---|---|---|
| Started | 10 | 11 | 10 | 10 | 10 | 11 |
| Completed | 10 | 11 | 10 | 10 | 10 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Test Product/Comparator Product/Placebo Product | Test Product/Placebo Product/Comparator Product | Comparator Product/Test Product/Placebo Product | Comparator Product/Placebo Product/ Test Product | Placebo Product/Test Product/Comparator Product | Placebo Product/Comparator Product/Test Product |
|---|---|---|---|---|---|---|
| Started | 10 | 11 | 10 | 10 | 10 | 11 |
| Completed | 10 | 11 | 10 | 10 | 10 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Test Product/Comparator Product/Placebo Product | Test Product/Placebo Product/Comparator Product | Comparator Product/Test Product/Placebo Product | Comparator Product/Placebo Product/ Test Product | Placebo Product/Test Product/Comparator Product | Placebo Product/Comparator Product/Test Product |
|---|---|---|---|---|---|---|
| Started | 10 | 11 | 10 | 10 | 10 | 11 |
| Completed | 10 | 11 | 10 | 10 | 10 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = \[(E1-R)/(E1-B)\]\*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
| Percentage SMHR | Test Product | Placebo Product |
|---|---|---|
| % Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel) | 29.67 ± 1.12 | 21.98 ± 1.12 |
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = \[(E1-E2)/ (E1-B)\]\*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
| Percentage RER | Test Product | Placebo Product |
|---|---|---|
| % Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel) | -23.65 ± 1.96 | -56.94 ± 1.96 |
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm\^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
| Microgram fluoride per square centimeter | Test Product | Placebo Product |
|---|---|---|
| Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel) | 2.98 ± 0.09 | 1.17 ± 0.09 |
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as: %SMHR = \[(E1-R)/(E1-B)\]\*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.
| Percentage SMHR | Test Product | Comparator Product |
|---|---|---|
| % SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride) | 29.67 ± 1.12 | 22.10 ± 1.12 |
The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = \[(E1-E2)/ (E1-B)\]\*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.
| Percentage RER | Test Product | Comparator Product |
|---|---|---|
| % RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride) | -23.65 ± 1.96 | -34.63 ± 1.96 |
The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm\^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.
| Microgram fluoride per square centimeter | Test Product | Comparator Product |
|---|---|---|
| EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride) | 2.98 ± 0.09 | 2.01 ± 0.09 |
Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | 0/62 (0%) | 0/62 (0%) | 8/62 (12.9%) |
| Comparator Product | 0/62 (0%) | 0/62 (0%) | 6/62 (9.7%) |
| Placebo Product | 0/62 (0%) | 0/62 (0%) | 10/62 (16.1%) |
| Event | Test Product | Comparator Product | Placebo Product |
|---|---|---|---|
| Oral Mucosal ErthyemaGastrointestinal disorders | 2/62 | 0/62 | 1/62 |
| NasopharyngitisInfections and infestations | 2/62 | 1/62 | 0/62 |
| Dental cariesGastrointestinal disorders | 0/62 | 0/62 | 1/62 |
| Lip haematomaGastrointestinal disorders | 1/62 | 0/62 | 0/62 |
| Mouth ulcerationGastrointestinal disorders | 0/62 | 1/62 | 0/62 |
| Oral DiscomfortGastrointestinal disorders | 0/62 | 0/62 | 1/62 |
| Oral PainGastrointestinal disorders | 0/62 | 0/62 | 1/62 |
| ToothacheGastrointestinal disorders | 1/62 | 0/62 | 1/62 |
| BronchitisInfections and infestations | 0/62 | 0/62 | 1/62 |
| Gastrointestinal Bactetial OvergrowthInfections and infestations | 0/62 | 0/62 | 1/62 |
Safety Population included all randomized participants who received at least 1 dose of study treatment. This population was based on the treatment the participant actually received.
| Age, Continuous(Years) | Overall Participants |
|---|---|
| Mean | 43.4 ± 13.38 |
| Sex: Female, Male(Participants) | Overall Participants |
|---|---|
| Female | 45 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | Overall Participants |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 58 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 14 |
| White | 42 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.
Data sharing details ↗ · clinicalstudydatarequest.com
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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