NCT02533466

In Vivo Investigation of Initial Stages of Enamel Erosion

Completed NA Results posted Last updated 2 August 2017

What this trial tests

NA trial testing Sodium fluoride + potassium nitrate in Tooth Erosion in 30 participants. Completed in 6 November 2015.

Timeline

1 October 2015

Primary endpoint
6 November 2015

6 November 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	30
Start date	1 October 2015
Primary completion	6 November 2015
Estimated completion	6 November 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• Sodium fluoride + potassium nitrate
• Potassium nitrate (POTASSIUM NITRATE) — full drug profile →

Conditions studied

• Tooth Erosion — all drugs for Tooth Erosion →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 70, any sex, with Tooth Erosion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge Primary · 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" struc

Group	Value	95% CI
Test Product	3.75	0 – 4
Reference Product	3.17	0 – 4

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge. Secondary · 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" struc

Group	Value	95% CI
Test Product	3.83	0.0 – 4.0
Reference Product	2.33	0.0 – 3.8

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge Secondary · 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" struc

Group	Value	95% CI
Test Product	3.17	0.0 – 4.0
Reference Product	1.08	0.0 – 2.7

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge Secondary · 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" struc

Group	Value	95% CI
Test Product	2.58	0.0 – 4.0
Reference Product	0.75	0.0 – 2.0

Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge Secondary · Baseline, 30 mins post dietary acid challenge

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

Group	Value	95% CI
Test Product	-12.81	± 9.101
Reference Product	-16.29	± 12.041

Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge Secondary · Baseline, 7 hours post dietary acid challenge

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

Group	Value	95% CI
Test Product	4.38	± 10.308
Reference Product	0.00	± 11.094

Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge Secondary · Baseline, 30 mins post dietary acid challenge

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

Group	Value	95% CI
Test Product	-0.71	± 0.854
Reference Product	-0.51	± 0.620

Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge Secondary · Baseline, 7 hours post dietary acid challenge

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

Group	Value	95% CI
Test Product	0.00	± 0.219
Reference Product	0.16	± 0.569

Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge Secondary · 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.

Group	Value	95% CI
Test Product	-1.81	± 3.885
Reference Product	-1.50	± 3.322

Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge Secondary · 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.

Group	Value	95% CI
Test Product	-0.25	± 2.463
Reference Product	-0.36	± 2.706

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.