Trial Outcomes & Findings for A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity (NCT NCT03238352)
NCT ID: NCT03238352
Last Updated: 2018-11-14
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
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Week 8
Results posted on
2018-11-14
Participant Flow
Participants were recruited from one center in USA.
A total of 123 participates were screened, out of which 89 participants were enrolled and randomized in the study. 34 participants were not randomized as all the 34 participants did not meet study criteria.
Participant milestones
| Measure |
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)
Participants rinsed twice daily (morning and evening) with 10 milliliters (mL) of oral rinse (1.5% KOX, 0 parts per million \[ppm\] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Negative Control (0.02% w/w Sodium Fluoride)
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% weight by weight \[w/w\] sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
23
|
23
|
|
Overall Study
COMPLETED
|
43
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)
Participants rinsed twice daily (morning and evening) with 10 milliliters (mL) of oral rinse (1.5% KOX, 0 parts per million \[ppm\] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Negative Control (0.02% w/w Sodium Fluoride)
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% weight by weight \[w/w\] sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)
n=43 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Negative Control (0.02% w/w Sodium Fluoride)
n=23 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
n=23 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
46.0 Years
STANDARD_DEVIATION 9.27 • n=39 Participants
|
41.5 Years
STANDARD_DEVIATION 9.76 • n=41 Participants
|
43.0 Years
STANDARD_DEVIATION 8.75 • n=35 Participants
|
44.1 Years
STANDARD_DEVIATION 9.38 • n=31 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
79 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
86 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
77 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The Intent-to-Treat (ITT) (N=85) population comprised of all randomized participants who 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 participant was randomized.
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 (1.5% KOX, 0 Ppm Fluoride, pH 7)
n=43 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Negative Control (0.02% w/w Sodium Fluoride)
n=20 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
n=22 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Schiff Sensitivity Score
Schiff score at baseline
|
2.59 Score on Scale
Standard Deviation 0.382
|
2.68 Score on Scale
Standard Deviation 0.406
|
2.52 Score on Scale
Standard Deviation 0.361
|
|
Change From Baseline in Schiff Sensitivity Score
Change from baseline in Schiff score at Week 8
|
-1.94 Score on Scale
Standard Deviation 0.773
|
-0.75 Score on Scale
Standard Deviation 0.866
|
-0.64 Score on Scale
Standard Deviation 0.848
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT (N=85) population included all participants who were randomized received at least one dose of investigational product and had at least one post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.
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 (1.5% KOX, 0 Ppm Fluoride, pH 7)
n=43 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Negative Control (0.02% w/w Sodium Fluoride)
n=20 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
n=22 Participants
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Tactile Threshold
Tactile threshold at baseline
|
10.35 Grams
Standard Deviation 1.289
|
10.25 Grams
Standard Deviation 1.118
|
10.23 Grams
Standard Deviation 1.066
|
|
Change From Baseline in Tactile Threshold
Change from baseline at Week 8
|
61.28 Grams
Standard Deviation 22.095
|
23.75 Grams
Standard Deviation 35.499
|
11.59 Grams
Standard Deviation 26.788
|
Adverse Events
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Negative Control (0.02% w/w Sodium Fluoride)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)
n=43 participants at risk
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm\] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Negative Control (0.02% w/w Sodium Fluoride)
n=23 participants at risk
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
n=23 participants at risk
Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
LIP ULCERATION
|
2.3%
1/43 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
2.3%
1/43 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
2.3%
1/43 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
0.00%
0/43 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
2.3%
1/43 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/43 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 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