Trial Outcomes & Findings for In Vivo Investigation of Initial Stages of Enamel Erosion (NCT NCT02533466)

NCT ID: NCT02533466

Last Updated: 2017-08-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline, 30 minutes post dietary acid challenge
• Results posted on: 2017-08-02

Participant Flow

Participants were recruited at 1 center in United Kingdom.

A total of 30 participants were screened and all of them were randomized.

Participant milestones

Measure	Test 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.	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.
Overall Study STARTED	16	14
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In Vivo Investigation of Initial Stages of Enamel Erosion

Baseline characteristics by cohort

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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	Total n=30 Participants Total of all reporting groups
Age, Continuous	36.1 Years STANDARD_DEVIATION 11.17 • n=5 Participants	38.1 Years STANDARD_DEVIATION 12.21 • n=7 Participants	37.1 Years STANDARD_DEVIATION 11.51 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
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 • Interval 0.0 to 4.0	3.17 Scores on grading scale Full Range 1.882 • Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.	3.83 Scores on grading scale Interval 0.0 to 4.0	2.33 Scores on grading scale Interval 0.0 to 3.8

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge	3.17 Scores on grading scale Interval 0.0 to 4.0	1.08 Scores on grading scale Interval 0.0 to 2.7

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge	2.58 Scores on grading scale Interval 0.0 to 4.0	0.75 Scores on grading scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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.

Saliva stored at 0 - 20°C was used for determining calcium concentration

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge	-12.81 ppm Standard Deviation 9.101	-16.29 ppm Standard Deviation 12.041

SECONDARY outcome

Timeframe: 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.

Saliva stored at 0 - 20°C was used for determining calcium concentration

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge	4.38 ppm Standard Deviation 10.308	0.00 ppm Standard Deviation 11.094

SECONDARY outcome

Timeframe: 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

Saliva stored at 0 - 20°C was used for determining pH

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge	-0.71 pH units Standard Deviation 0.854	-0.51 pH units Standard Deviation 0.620

SECONDARY outcome

Timeframe: 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

Saliva stored at 0 - 20°C was used for determining pH

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge	0.00 pH units Standard Deviation 0.219	0.16 pH units Standard Deviation 0.569

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge	-1.81 scores on a scale Standard Deviation 3.885	-1.50 scores on a scale Standard Deviation 3.322

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Test Product n=16 Participants 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.	Reference Product n=14 Participants 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.
Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge	-0.25 scores on a scale Standard Deviation 2.463	-0.36 scores on a scale Standard Deviation 2.706

Adverse Events

Test Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Product

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER