Trial Outcomes & Findings for To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH) (NCT NCT02937623)
NCT ID: NCT02937623
Last Updated: 2018-01-29
Results Overview
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
COMPLETED
NA
126 participants
At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study
2018-01-29
Participant Flow
All participants were recruited at a single center in USA.
A total of 135 participants were screened, out of which 126 were enrolled in study. 9 participants were screening failure so did not enrolled. Out of 126 enrolled participants, 120 participants were randomized. 6 participants were not randomized as 1 had adverse event, 3 withdrew from study before randomization \& 2 because of unspecified reasons.
Participant milestones
| Measure |
Test Product: Dissolvable Polymer Strip Containing Novamin
In this arm, participants received an experimental dissolvable polymer strip containing 15 % weight/weight (w/w) calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
|
Reference Product: No Treatment/Product
In this arm, participants did not receive any treatment/product.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH)
Baseline characteristics by cohort
| Measure |
Test Product: Dissolvable Polymer Strip Containing Novamin
n=60 Participants
In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
|
Reference Product: No Treatment/Product
n=60 Participants
In this arm, participants did not receive any treatment/product.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 11.75 • n=99 Participants
|
38.8 years
STANDARD_DEVIATION 11.36 • n=107 Participants
|
38.2 years
STANDARD_DEVIATION 11.52 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the studyPopulation: Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Outcome measures
| Measure |
Test Product: Dissolvable Polymer Strip Containing Novamin
n=60 Participants
In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
|
Reference Product: No Treatment/Product
n=60 Participants
In this arm, participants did not receive any treatment/product.
|
|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score After 10 Minutes
|
-0.46 score on a scale
Standard Deviation 0.531
|
-0.02 score on a scale
Standard Deviation 0.260
|
SECONDARY outcome
Timeframe: At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the studyPopulation: ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Outcome measures
| Measure |
Test Product: Dissolvable Polymer Strip Containing Novamin
n=60 Participants
In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
|
Reference Product: No Treatment/Product
n=60 Participants
In this arm, participants did not receive any treatment/product.
|
|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours
Change from baseline after 2 hours
|
-0.78 score on a scale
Standard Deviation 0.654
|
-0.08 score on a scale
Standard Deviation 0.334
|
|
Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours
Change from baseline after 4 hours
|
-1.03 score on a scale
Standard Deviation 0.698
|
-0.12 score on a scale
Standard Deviation 0.361
|
SECONDARY outcome
Timeframe: At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the studyPopulation: ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has 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 (pre-treatment), the maximum force used was 20g; at all subsequent time points (post treatment), it was 80g.
Outcome measures
| Measure |
Test Product: Dissolvable Polymer Strip Containing Novamin
n=60 Participants
In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
|
Reference Product: No Treatment/Product
n=60 Participants
In this arm, participants did not receive any treatment/product.
|
|---|---|---|
|
Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours
Change from baseline after 10 minutes
|
8.92 gram (g)
Standard Deviation 10.580
|
0.50 gram (g)
Standard Deviation 2.383
|
|
Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours
Change from baseline after 2 hours
|
16.50 gram (g)
Standard Deviation 16.424
|
0.75 gram (g)
Standard Deviation 2.405
|
|
Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours
Change from baseline after 4 hours
|
24.00 gram (g)
Standard Deviation 20.704
|
0.92 gram (g)
Standard Deviation 2.346
|
SECONDARY outcome
Timeframe: At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the studyPopulation: ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.
Participants rated the intensity of their response to the evaporative air stimulus using a 10 point numerical rating scale of 1 (No Pain) to 10 (Intense Pain).
Outcome measures
| Measure |
Test Product: Dissolvable Polymer Strip Containing Novamin
n=60 Participants
In this arm, participants received an experimental dissolvable polymer strip containing 15 % w/w calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).
|
Reference Product: No Treatment/Product
n=60 Participants
In this arm, participants did not receive any treatment/product.
|
|---|---|---|
|
Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours
Change from baseline after 10 minutes
|
-1.44 score on a scale
Standard Deviation 1.571
|
-0.11 score on a scale
Standard Deviation 0.893
|
|
Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours
Change from baseline after 2 hours
|
-1.92 score on a scale
Standard Deviation 1.762
|
-0.47 score on a scale
Standard Deviation 1.149
|
|
Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours
Change from baseline after 4 hours
|
-2.49 score on a scale
Standard Deviation 1.917
|
-0.33 score on a scale
Standard Deviation 0.896
|
Adverse Events
Test Product: Dissolvable Polymer Strip Containing Novamin
Reference Product: No Treatment/Product
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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