Tooth Erosion
Conditions
Brief summary
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.
Interventions
OTHERSodium fluoride + potassium nitrate
Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate
OTHERPotassium nitrate
Experimental toothpaste containing 5% potassium nitrate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Aged at least 18 years * Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination. * Absence of any condition that would impact the participant's safety or well-being, or affect the participant's ability to understand and follow study procedures and requirements. * Two anterior maxillary teeth, without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations.
Exclusion criteria
* Pregnant or breast feeding women * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit * Recent history (within the last year) of alcohol or other substance abuse * Presence of a disease or medication which in the opinion of the investigator, will impact on assessments * Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening * Surface irregularities, discoloration due to trauma, restorations and hypo or hyperplasic areas which, in the opinion of the investigator or dental assessor, would prevent accurate impressions and grading * Daily doses of a medication which, in the opinion of the investigator, could impact the assessment, for example acidic medications * Any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge | Baseline, 30 minutes post dietary 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge | Baseline, 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 |
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge | Baseline, 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 |
| Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge | Baseline, 30 mins post dietary acid challenge | Saliva stored at 0 - 20°C was used for determining calcium concentration |
| Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge | Baseline, 7 hours post dietary acid challenge | Saliva stored at 0 - 20°C was used for determining calcium concentration |
| Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge. | Baseline, 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 |
| Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge | Baseline, 7 hours post dietary acid challenge | Saliva stored at 0 - 20°C was used for determining pH |
| Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge | Baseline, 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. |
| Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge | Baseline, 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. |
| Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge | Baseline, 30 mins post dietary acid challenge | Saliva stored at 0 - 20°C was used for determining pH |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at 1 center in United Kingdom.
Pre-assignment details
A total of 30 participants were screened and all of them were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Test Product Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water. | 16 |
| Reference Product Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Test Product | Reference Product | Total |
|---|---|---|---|
| Age, Continuous | 36.1 Years STANDARD_DEVIATION 11.17 | 38.1 Years STANDARD_DEVIATION 12.21 | 37.1 Years STANDARD_DEVIATION 11.51 |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
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
Population: The Per Protocol (PP) population was defined as those subjects in the ITT (intent to treat) population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge | 3.75 Scores on grading scale | Full Range 1.917 |
| Reference Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge | 3.17 Scores on grading scale | Full Range 1.882 |
p-value: 0.267395% CI: [-1, 0]Wilcoxon Rank Sum test
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge | -0.25 scores on a scale | Standard Deviation 2.463 |
| Reference Product | Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge | -0.36 scores on a scale | Standard Deviation 2.706 |
p-value: 0.912195% CI: [-1.6, 1.4]ANCOVA
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge | -1.81 scores on a scale | Standard Deviation 3.885 |
| Reference Product | Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge | -1.50 scores on a scale | Standard Deviation 3.322 |
p-value: 0.782995% CI: [-2.2, 2.8]ANCOVA
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge | 0.00 pH units | Standard Deviation 0.219 |
| Reference Product | Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge | 0.16 pH units | Standard Deviation 0.569 |
p-value: 0.393995% CI: [-0.1, 0.3]ANCOVA
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge | -0.71 pH units | Standard Deviation 0.854 |
| Reference Product | Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge | -0.51 pH units | Standard Deviation 0.62 |
p-value: 0.461195% CI: [-0.4, 0.8]ANCOVA
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge | 4.38 ppm | Standard Deviation 10.308 |
| Reference Product | Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge | 0.00 ppm | Standard Deviation 11.094 |
p-value: 0.40895% CI: [-7.9, 3.3]ANCOVA
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Product | Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge | -12.81 ppm | Standard Deviation 9.101 |
| Reference Product | Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge | -16.29 ppm | Standard Deviation 12.041 |
p-value: 0.606195% CI: [-6.8, 4.1]ANCOVA
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge. | 3.83 Scores on grading scale |
| Reference Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge. | 2.33 Scores on grading scale |
p-value: 0.06995% CI: [-1.8, 0]Wilcoxon Rank Sum Test
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge | 3.17 Scores on grading scale |
| Reference Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge | 1.08 Scores on grading scale |
p-value: 0.06895% CI: [-2.7, 0]Wilcoxon Rank Sum test
Secondary
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
Population: The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge | 2.58 Scores on grading scale |
| Reference Product | Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge | 0.75 Scores on grading scale |
p-value: 0.065495% CI: [-3, 0]Wilcoxon Rank Sum test.