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A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity

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ClinicalTrials.gov Identifier: NCT03238352
Recruitment Status : Completed
First Posted : August 3, 2017
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Dentin Sensitivity
Interventions Device: Potassium oxalate
Drug: Sodium fluoride
Other: Placebo
Enrollment 89
Recruitment Details Participants were recruited from one center in USA.
Pre-assignment Details 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.
Arm/Group Title Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 43 23 23
Completed 43 20 22
Not Completed 0 3 1
Reason Not Completed
Lost to Follow-up             0             2             1
Withdrawal by Subject             0             1             0
Arm/Group Title Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7) Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 43 23 23 89
Hide Baseline Analysis Population Description
Safety population comprised of all randomized participants who received at least 1 dose of study treatment. This population was based on the treatment the participant actually received.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 23 participants 23 participants 89 participants
46.0  (9.27) 41.5  (9.76) 43.0  (8.75) 44.1  (9.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 23 participants 23 participants 89 participants
Female
37
  86.0%
19
  82.6%
23
 100.0%
79
  88.8%
Male
6
  14.0%
4
  17.4%
0
   0.0%
10
  11.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 23 participants 23 participants 89 participants
Hispanic or Latino
2
   4.7%
0
   0.0%
1
   4.3%
3
   3.4%
Not Hispanic or Latino
41
  95.3%
23
 100.0%
22
  95.7%
86
  96.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 23 participants 23 participants 89 participants
American Indian or Alaska Native
0
   0.0%
1
   4.3%
0
   0.0%
1
   1.1%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  14.0%
2
   8.7%
3
  13.0%
11
  12.4%
White
37
  86.0%
20
  87.0%
20
  87.0%
77
  86.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Schiff Sensitivity Score
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 43 20 22
Mean (Standard Deviation)
Unit of Measure: Score on Scale
Schiff score at baseline 2.59  (0.382) 2.68  (0.406) 2.52  (0.361)
Change from baseline in Schiff score at Week 8 -1.94  (0.773) -0.75  (0.866) -0.64  (0.848)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7), Negative Control (0.02% w/w Sodium Fluoride)
Comments Test Product versus Negative Control at Week 8 is a primary endpoint comparison.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with treatment as factor and baseline Schiff score as covariate.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-1.657 to -0.782
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.220
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7), Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with treatment as factor and baseline Schiff score as covariate.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value -1.28
Confidence Interval (2-Sided) 95%
-1.705 to -0.858
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.213
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7), Negative Control (0.02% w/w Sodium Fluoride), Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Comments Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA model with treatment as factor and baseline Schiff score as covariate.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value -1.25
Confidence Interval (2-Sided) 95%
-1.600 to -0.901
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.176
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
2.Secondary Outcome
Title Change From Baseline in Tactile Threshold
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 43 20 22
Mean (Standard Deviation)
Unit of Measure: Grams
Tactile threshold at baseline 10.35  (1.289) 10.25  (1.118) 10.23  (1.066)
Change from baseline at Week 8 61.28  (22.095) 23.75  (35.499) 11.59  (26.788)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7), Negative Control (0.02% w/w Sodium Fluoride)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0004
Comments P-value from Van Elteren test
Method ANCOVA
Comments From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.
Method of Estimation Estimation Parameter Diference of Least Square mean
Estimated Value 37.46
Confidence Interval (2-Sided) 95%
22.916 to 51.995
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.306
Estimation Comments Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7), Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments P-value from Van Elteren test
Method ANCOVA
Comments From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.
Method of Estimation Estimation Parameter Diference of Least Square mean
Estimated Value 49.88
Confidence Interval (2-Sided) 95%
35.791 to 63.966
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.079
Estimation Comments Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7), Negative Control (0.02% w/w Sodium Fluoride), Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Comments Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments P-value from Van Elteren test.
Method ANCOVA
Comments From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.
Method of Estimation Estimation Parameter Diference of Least Square mean
Estimated Value 43.67
Confidence Interval (2-Sided) 95%
32.001 to 55.334
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.862
Estimation Comments Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)      0/23 (0.00%)      0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/43 (0.00%)      0/23 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Negative Control (0.02% w/w Sodium Fluoride) Placebo (0% KOX, 0 Ppm Fluoride, pH 7)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/43 (9.30%)      0/23 (0.00%)      2/23 (8.70%)    
Gastrointestinal disorders       
LIP ULCERATION   1/43 (2.33%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
MOUTH ULCERATION   1/43 (2.33%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
ORAL DISCOMFORT   1/43 (2.33%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
ORAL MUCOSAL EXFOLIATION   0/43 (0.00%)  0 0/23 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations       
GASTROENTERITIS   0/43 (0.00%)  0 0/23 (0.00%)  0 1/23 (4.35%)  1
Injury, poisoning and procedural complications       
TRAUMATIC ULCER   1/43 (2.33%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03238352     History of Changes
Other Study ID Numbers: 207656
First Submitted: July 19, 2017
First Posted: August 3, 2017
Results First Submitted: October 15, 2018
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018