Trial Outcomes & Findings for A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity (NCT NCT03310268)
NCT ID: NCT03310268
Last Updated: 2020-11-27
Results Overview
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2020-11-27
Participant Flow
Participants were recruited from one center in China.
A total of 688 participates were screened, out of which 185 participants were randomized in the study and 503 participants were not randomized as 474 participants did not meet study criteria, 6 were reported with adverse events, 3 because of protocol violation, 4 withdrew consent, and 3 because of unspecified reasons.
Participant milestones
| Measure |
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])
Participants were instructed to self administer experimental dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million \[ppm\] fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Negative Control (1400 Ppm Fluoride as SMFP)
Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as sodium monofluorophosphate (SMFP)which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])
Participants were instructed to self administer positive control dentifrice containing stannous chloride (SnCl2) and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
61
|
|
Overall Study
COMPLETED
|
61
|
57
|
61
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
0
|
Reasons for withdrawal
| Measure |
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])
Participants were instructed to self administer experimental dentifrice containing 0.454% stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF) (1450 parts per million \[ppm\] fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Negative Control (1400 Ppm Fluoride as SMFP)
Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as sodium monofluorophosphate (SMFP)which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])
Participants were instructed to self administer positive control dentifrice containing stannous chloride (SnCl2) and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
|---|---|---|---|
|
Overall Study
(Not specified)
|
1
|
5
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])
n=62 Participants
Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Negative Control (1400 Ppm Fluoride as SMFP)
n=62 Participants
Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])
n=61 Participants
Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.2 Years
STANDARD_DEVIATION 10.83 • n=99 Participants
|
40.3 Years
STANDARD_DEVIATION 9.12 • n=107 Participants
|
39.4 Years
STANDARD_DEVIATION 9.95 • n=206 Participants
|
39.9 Years
STANDARD_DEVIATION 9.94 • n=7 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
161 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
185 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
185 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Stratification n (%)
Maximum baseline Schiff score 2
|
44 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
131 Participants
n=7 Participants
|
|
Stratification n (%)
Maximum baseline Schiff score 3
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: The Intent-to-treat (ITT) population included those participants who were randomized, received at least 1 dose of study treatment, and had at least 1 post baseline efficacy evaluation. This population was based on the treatment to which the subject was randomized. The primary population for assessment of efficacy was the ITT population.
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.
Outcome measures
| Measure |
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])
n=62 Participants
Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Negative Control (1400 Ppm Fluoride as SMFP)
n=60 Participants
Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])
n=61 Participants
Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushedtwice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
|---|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment
Schiff score at baseline
|
2.22 Score on Scale
Standard Deviation 0.369
|
2.23 Score on Scale
Standard Deviation 0.385
|
2.18 Score on Scale
Standard Deviation 0.303
|
|
Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment
Schiff score at Week 8
|
1.69 Score on Scale
Standard Deviation 0.449
|
1.50 Score on Scale
Standard Deviation 0.526
|
1.70 Score on Scale
Standard Deviation 0.572
|
|
Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment
Change from baseline in Schiff score at Week 8
|
-0.53 Score on Scale
Standard Deviation 0.562
|
-0.72 Score on Scale
Standard Deviation 0.567
|
-0.48 Score on Scale
Standard Deviation 0.591
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT population included those participants who were randomized, received at least 1 dose of study treatment, and had at least 1 post baseline efficacy evaluation. This population was based on the treatment to which the subject was randomized. The primary population for assessment of efficacy was the ITT population.
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Outcome measures
| Measure |
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])
n=62 Participants
Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Negative Control (1400 Ppm Fluoride as SMFP)
n=60 Participants
Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])
n=61 Participants
Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushedtwice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
|---|---|---|---|
|
Change From Baseline in Tactile Threshold After 8 Weeks of Treatment
Tactile threshold at baseline
|
11.13 Grams
Standard Deviation 2.294
|
11.42 Grams
Standard Deviation 2.272
|
11.80 Grams
Standard Deviation 3.032
|
|
Change From Baseline in Tactile Threshold After 8 Weeks of Treatment
Tactile threshold at Week 8
|
28.52 Grams
Standard Deviation 22.846
|
36.49 Grams
Standard Deviation 29.124
|
33.93 Grams
Standard Deviation 24.902
|
|
Change From Baseline in Tactile Threshold After 8 Weeks of Treatment
Change from baseline at Week 8
|
17.38 Grams
Standard Deviation 22.631
|
25.00 Grams
Standard Deviation 28.769
|
22.31 Grams
Standard Deviation 24.229
|
Adverse Events
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Negative Control (1400 Ppm Fluoride as SMFP)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product (0.454% SnF2 and 0.072% NaF [1450 Ppm Fluoride])
n=62 participants at risk
Participants were instructed to self administer experimental dentifrice containing 0.454% SnF2 and 0.072% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Negative Control (1400 Ppm Fluoride as SMFP)
n=62 participants at risk
Participants were instructed to self administer negative control dentifrice containing 1400 ppm fluoride as SMFP which covered the full length of toothbrush head (full ribbon) and brushed twice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
Positive Control (SnCl2 and 0.15% NaF [1450 Ppm Fluoride])
n=61 participants at risk
Participants were instructed to self administer positive control dentifrice containing SnCl2 and 0.15% NaF (1450 ppm fluoride in total) which covered the full length of toothbrush head (full ribbon) and brushedtwice daily (morning and evening) for one timed minute (in their usual manner) and then expectorated.
|
|---|---|---|---|
|
Gastrointestinal disorders
Lip Ulceration
|
1.6%
1/62 • Number of events 3 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
0.00%
0/61 • From screening up to Week 8
|
|
Gastrointestinal disorders
Mouth Ulceration
|
1.6%
1/62 • Number of events 1 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
0.00%
0/61 • From screening up to Week 8
|
|
Gastrointestinal disorders
Non infective Gingivitis
|
1.6%
1/62 • Number of events 1 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
0.00%
0/61 • From screening up to Week 8
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/62 • From screening up to Week 8
|
3.2%
2/62 • Number of events 3 • From screening up to Week 8
|
0.00%
0/61 • From screening up to Week 8
|
|
Infections and infestations
Oral Herpes
|
1.6%
1/62 • Number of events 1 • From screening up to Week 8
|
1.6%
1/62 • Number of events 1 • From screening up to Week 8
|
1.6%
1/61 • Number of events 1 • From screening up to Week 8
|
|
Infections and infestations
Angular Chelitis
|
0.00%
0/62 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
1.6%
1/61 • Number of events 1 • From screening up to Week 8
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/62 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
1.6%
1/61 • Number of events 1 • From screening up to Week 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/62 • Number of events 1 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
1.6%
1/61 • Number of events 1 • From screening up to Week 8
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.6%
1/62 • Number of events 1 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
0.00%
0/61 • From screening up to Week 8
|
|
General disorders
Pyrexia
|
1.6%
1/62 • Number of events 1 • From screening up to Week 8
|
0.00%
0/62 • From screening up to Week 8
|
0.00%
0/61 • From screening up to Week 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER