Trial Outcomes & Findings for A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices (NCT NCT03267511)
NCT ID: NCT03267511
Last Updated: 2019-01-08
Results Overview
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 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 area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
COMPLETED
PHASE2
123 participants
Baseline, Week 8 post treatment administration
2019-01-08
Participant Flow
Participants were recruited from one center in USA
A total of 137 participates were screened, out of which 123 participants were enrolled and randomized in the study. 14 participants were not randomized as 11 participants did not meet study criteria, 2 participants withdrew by consent and 1 participant was lost to follow-up.
Participant milestones
| Measure |
Test Product 1
Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica.
|
Test Product 2
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% sodium tripolyphosphate (STP).
|
Reference Product 1
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
|
Reference Product 2
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
30
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test Product 1
Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica.
|
Test Product 2
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% sodium tripolyphosphate (STP).
|
Reference Product 1
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
|
Reference Product 2
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices
Baseline characteristics by cohort
| Measure |
Test Product 1
n=31 Participants
Participants were instructed to apply experimental dentifrice containing 5% KNO3) / 0.2542% NaF dentifrice with 0.5% spherical silica.
|
Test Product 2
n=31 Participants
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
|
Reference Product 1
n=30 Participants
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
|
Reference Product 2
n=31 Participants
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
45.5 Years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
46.2 Years
STANDARD_DEVIATION 12.42 • n=7 Participants
|
41.3 Years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
42.9 Years
STANDARD_DEVIATION 10.57 • n=4 Participants
|
44.0 Years
STANDARD_DEVIATION 11.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8 post treatment administrationPopulation: The Intent-to-Treat (ITT) (n=123) population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.
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 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 area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
Test Product 1
n=31 Participants
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica.
|
Test Product 2
n=31 Participants
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
|
Reference Product 1
n=30 Participants
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
|
Reference Product 2
n=31 Participants
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
|
|---|---|---|---|---|
|
Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks.
|
-0.32 Score on a scale
Standard Error 0.090
|
-0.47 Score on a scale
Standard Error 0.090
|
-0.38 Score on a scale
Standard Error 0.091
|
-0.40 Score on a scale
Standard Error 0.090
|
SECONDARY outcome
Timeframe: Baseline, Week 8 post treatment administrationPopulation: The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.
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 area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
Test Product 1
n=61 Participants
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica.
|
Test Product 2
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
|
Reference Product 1
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
|
Reference Product 2
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
|
|---|---|---|---|---|
|
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1)
|
0.06 Score on a scale
Standard Error 0.128
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8 post treatment administrationPopulation: The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.
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 area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
Test Product 1
n=62 Participants
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica.
|
Test Product 2
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
|
Reference Product 1
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
|
Reference Product 2
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
|
|---|---|---|---|---|
|
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2)
|
-0.07 Score on a scale
Standard Error 0.128
|
—
|
—
|
—
|
Adverse Events
Test Product 1
Test Product 2
Reference Product 1
Reference Product 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product 1
n=31 participants at risk
Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica.
|
Test Product 2
n=31 participants at risk
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
|
Reference Product 1
n=30 participants at risk
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
|
Reference Product 2
n=31 participants at risk
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
6.5%
2/31 • Number of events 2 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
Gastrointestinal disorders
LIP ULCERATION
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
Gastrointestinal disorders
PALATAL ULCER
|
0.00%
0/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
Infections and infestations
ANGULAR CHEILITIS
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
Additional Information
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