Trial Outcomes & Findings for Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices (NCT NCT03160703)
NCT ID: NCT03160703
Last Updated: 2019-06-04
Results Overview
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of the allocated study dentifrice, after 4 weeks twice daily use. 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
NA
220 participants
Baseline and Week 4
2019-06-04
Participant Flow
Participants were recruited from one center in Canada.
A total of 225 participants were screened, of which 220 participants were enrolled and randomized in the study. A total of 5 participants were not randomized in study as 3 participants did not meet study criteria, and 2 withdrew their consent.
Participant milestones
| Measure |
Test Dentifrice 1 (RDA~58)
Participants applied experimental dentifrice containing 0.454 percent (%) stannous fluoride (SnF2) / 5% sodium tripolyphosphate (STP); 2.0% abrasive silica
|
Test Dentifrice 2 (RDA~77)
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
|
Reference Dentifrice 1 (RDA~80)
Participants applied dentifrice containing 1000 parts per million (ppm) fluoride as Sodium Monofluorophosphate (SMFP)
|
Reference Dentifrice 2 (RDA~120)
Participants applied dentifrice containing 0.454% SnF2
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
55
|
55
|
|
Overall Study
COMPLETED
|
55
|
55
|
55
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test Dentifrice 1 (RDA~58)
Participants applied experimental dentifrice containing 0.454 percent (%) stannous fluoride (SnF2) / 5% sodium tripolyphosphate (STP); 2.0% abrasive silica
|
Test Dentifrice 2 (RDA~77)
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
|
Reference Dentifrice 1 (RDA~80)
Participants applied dentifrice containing 1000 parts per million (ppm) fluoride as Sodium Monofluorophosphate (SMFP)
|
Reference Dentifrice 2 (RDA~120)
Participants applied dentifrice containing 0.454% SnF2
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Investigate the Stain Control of Two Stannous Fluoride Dentifrices
Baseline characteristics by cohort
| Measure |
Test Dentifrice 1 (RDA~58)
n=55 Participants
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica
|
Test Dentifrice 2 (RDA~77)
n=55 Participants
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
|
Reference Dentifrice 1 (RDA~80)
n=55 Participants
Participants applied dentifrice containing 1000 ppm fluoride as SMFP
|
Reference Dentifrice 2 (RDA~120)
n=55 Participants
Participants applied dentifrice containing 0.454% SnF2
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
46.1 Years
STANDARD_DEVIATION 11.20 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
46.6 Years
STANDARD_DEVIATION 12.28 • n=4 Participants
|
47.7 Years
STANDARD_DEVIATION 11.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
159 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
61 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
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
41 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
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 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 and Week 4Population: The Intent-To-Treat (ITT) population (N=219) included all participants who were randomized, received at least 1 dose of investigational product, and had at least 1 post-baseline efficacy evaluation and were reported by randomized treatment.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of the allocated study dentifrice, after 4 weeks twice daily use. 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 Dentifrice 1 (RDA~58)
n=55 Participants
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica
|
Test Dentifrice 2 (RDA~77)
n=55 Participants
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
|
Reference Dentifrice 1 (RDA~80)
n=55 Participants
Participants applied dentifrice containing 1000 ppm fluoride as SMFP
|
Reference Dentifrice 2 (RDA~120)
n=54 Participants
Participants applied dentifrice containing 0.454% SnF2
|
|---|---|---|---|---|
|
Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4
Baseline
|
1.38 Score on a scale
Standard Deviation 0.423
|
1.43 Score on a scale
Standard Deviation 0.422
|
1.42 Score on a scale
Standard Deviation 0.626
|
1.38 Score on a scale
Standard Deviation 0.443
|
|
Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4
Week 4
|
0.08 Score on a scale
Standard Deviation 0.078
|
0.05 Score on a scale
Standard Deviation 0.057
|
0.10 Score on a scale
Standard Deviation 0.096
|
0.16 Score on a scale
Standard Deviation 0.141
|
Adverse Events
Test Dentifrice 1 (RDA~58)
Test Dentifrice 2 (RDA~77)
Reference Dentifrice 1 (RDA~80)
Reference Dentifrice 2 (RDA~120)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Dentifrice 1 (RDA~58)
n=55 participants at risk
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica
|
Test Dentifrice 2 (RDA~77)
n=55 participants at risk
Participants applied experimental dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica
|
Reference Dentifrice 1 (RDA~80)
n=55 participants at risk
Participants applied dentifrice containing 1000 ppm fluoride as SMFP
|
Reference Dentifrice 2 (RDA~120)
n=55 participants at risk
Participants applied dentifrice containing 0.454% SnF2
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
BACK INJURY
|
1.8%
1/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
0.00%
0/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
0.00%
0/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
0.00%
0/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
0.00%
0/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
1.8%
1/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
0.00%
0/55 • Approximately 35 days (28+/- 2 days, maximum 30 days plus 5 days follow up after last use of study product.
Safety population (N=220) included all participants who were randomized and received at least one dose of investigational product and was reported by treatment received.
|
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