An interventional study of Sodium fluoride + potassium nitrate and Potassium nitrate in Tooth Erosion, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-02.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Basic science
This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 30 is close to 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.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
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.
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.
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.
Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water.
Other: Sodium fluoride + potassium nitrate
Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water.
Other: Potassium nitrate
Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate
Experimental toothpaste containing 5% potassium nitrate
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Time frame: Baseline, 30 minutes post dietary acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Time frame: Baseline, 2 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Time frame: Baseline, 4 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
Time frame: Baseline, 7 hours post acid challenge
Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining calcium concentration
Time frame: Baseline, 30 mins post dietary acid challenge
Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining calcium concentration
Time frame: Baseline, 7 hours post dietary acid challenge
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining pH
Time frame: Baseline, 30 mins post dietary acid challenge
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining pH
Time frame: Baseline, 7 hours post dietary acid challenge
Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
Time frame: Baseline, 30 mins post dietary acid challenge
Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
Time frame: Baseline, 7 hours post dietary acid challenge
Participants were recruited at 1 center in United Kingdom.
| Milestone | Test Product | Reference Product |
|---|---|---|
| Started | 16 | 14 |
| Completed | 16 | 14 |
| Not completed | 0 | 0 |
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
| Scores on grading scale | Test Product | Reference Product |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge | 3.75 ± 1.917 | 3.17 ± 1.882 |
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
| Scores on grading scale | Test Product | Reference Product |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge. | 3.83 (0.0 to 4.0) | 2.33 (0.0 to 3.8) |
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
| Scores on grading scale | Test Product | Reference Product |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge | 3.17 (0.0 to 4.0) | 1.08 (0.0 to 2.7) |
The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable
| Scores on grading scale | Test Product | Reference Product |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge | 2.58 (0.0 to 4.0) | 0.75 (0.0 to 2.0) |
Saliva stored at 0 - 20°C was used for determining calcium concentration
| ppm | Test Product | Reference Product |
|---|---|---|
| Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge | -12.81 ± 9.101 | -16.29 ± 12.041 |
Saliva stored at 0 - 20°C was used for determining calcium concentration
| ppm | Test Product | Reference Product |
|---|---|---|
| Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge | 4.38 ± 10.308 | 0.00 ± 11.094 |
Saliva stored at 0 - 20°C was used for determining pH
| pH units | Test Product | Reference Product |
|---|---|---|
| Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge | -0.71 ± 0.854 | -0.51 ± 0.620 |
Saliva stored at 0 - 20°C was used for determining pH
| pH units | Test Product | Reference Product |
|---|---|---|
| Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge | 0.00 ± 0.219 | 0.16 ± 0.569 |
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
| scores on a scale | Test Product | Reference Product |
|---|---|---|
| Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge | -1.81 ± 3.885 | -1.50 ± 3.322 |
Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.
| scores on a scale | Test Product | Reference Product |
|---|---|---|
| Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge | -0.25 ± 2.463 | -0.36 ± 2.706 |
Collected over Baseline upto Day 2. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | — | 0/16 (0%) | 0/16 (0%) |
| Reference Product | — | 0/14 (0%) | 0/14 (0%) |
The Per Protocol (PP) population was the primary population.
| Age, Continuous(Years) | Test Product | Reference Product | Total |
|---|---|---|---|
| Mean | 36.1 ± 11.17 | 38.1 ± 12.21 | 37.1 ± 11.51 |
| Sex: Female, Male(Participants) | Test Product | Reference Product | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 12 | 13 | 25 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.