NCT03267511

A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices

Completed Phase 2 Results posted Last updated 8 January 2019

What this trial tests

Phase 2 trial testing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica in Oral Hygiene in 123 participants. Completed in 2 December 2017.

Timeline

25 September 2017

Primary endpoint
2 December 2017

2 December 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	123
Start date	25 September 2017
Primary completion	2 December 2017
Estimated completion	2 December 2017
Sites	1 location across United States

Drugs / interventions tested

• 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica — full drug profile →
• 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP — full drug profile →
• 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica — full drug profile →
• 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP — full drug profile →

Conditions studied

• Oral Hygiene — all drugs for Oral Hygiene →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Oral Hygiene. 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 Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks. Primary · Baseline, Week 8 post treatment administration

An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the fol

Group	Value	95% CI
Test Product 1	-0.32	± 0.090
Test Product 2	-0.47	± 0.090
Reference Product 1	-0.38	± 0.091
Reference Product 2	-0.40	± 0.090

Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1) Secondary · Baseline, Week 8 post treatment administration

An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 1 and reference product 1 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the a

Group	Value	95% CI
Test Product 1 vs Reference Product 1	0.06	± 0.128

Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2) Secondary · Baseline, Week 8 post treatment administration

An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 2 and reference product 2 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the a

Group	Value	95% CI
Test Product 2 vs Reference Product 2	-0.07	± 0.128

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Product 1

Serious: 0/31 (0%)

Deaths: 0/31

Test Product 2

Serious: 0/31 (0%)

Deaths: 0/31

Reference Product 1

Serious: 0/30 (0%)

Deaths: 0/30

Reference Product 2

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (5 terms — click to expand)

Reaction	System	Test Product 1	Test Product 2	Reference Product 1	Reference Product 2
TRAUMATIC ULCER	Injury, poisoning and procedural complications	—	—	—	—
LIP ULCERATION	Gastrointestinal disorders	—	—	—	—
MOUTH ULCERATION	Gastrointestinal disorders	—	—	—	—
PALATAL ULCER	Gastrointestinal disorders	—	—	—	—
ANGULAR CHEILITIS	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT03267511 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Stain control with two experimental dentin hypersensitivity toothpastes containing spherical silica: a randomised, early-phase development study.
   Mason S, Young S, Araga M, Butler A, et al · · 2019 · cited 4× · PMID 31231545 · DOI 10.1038/s41405-019-0016-x