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Trial record 25 of 32 for:    FLUORIDE ION AND NITRATE ION

A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03267511
Recruitment Status : Completed
First Posted : August 30, 2017
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Oral Hygiene
Interventions Drug: 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica
Drug: 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP
Drug: 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica
Drug: 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP
Enrollment 123
Recruitment Details Participants were recruited from one center in USA
Pre-assignment Details A total of 137 participates were screened, out of which 123 participants were enrolled and randomized in the study. 14 participants were not randomized as 11 participants did not meet study criteria, 2 participants withdrew by consent and 1 participant was lost to follow-up.
Arm/Group Title Test Product 1 Test Product 2 Reference Product 1 Reference Product 2
Hide Arm/Group Description Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% sodium tripolyphosphate (STP). Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
Period Title: Overall Study
Started 31 31 30 31
Completed 31 31 30 30
Not Completed 0 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             0             1
Arm/Group Title Test Product 1 Test Product 2 Reference Product 1 Reference Product 2 Total
Hide Arm/Group Description Participants were instructed to apply experimental dentifrice containing 5% KNO3) / 0.2542% NaF dentifrice with 0.5% spherical silica. Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. Total of all reporting groups
Overall Number of Baseline Participants 31 31 30 31 123
Hide Baseline Analysis Population Description
Safety population (N=123) comprised of all participants who were randomized and received at least one dose of study treatment during the study. This population was based on the treatment the participant actually received.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 30 participants 31 participants 123 participants
45.5  (11.32) 46.2  (12.42) 41.3  (11.25) 42.9  (10.57) 44.0  (11.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 30 participants 31 participants 123 participants
Female
26
  83.9%
23
  74.2%
19
  63.3%
23
  74.2%
91
  74.0%
Male
5
  16.1%
8
  25.8%
11
  36.7%
8
  25.8%
32
  26.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 30 participants 31 participants 123 participants
Hispanic or Latino
0
   0.0%
1
   3.2%
0
   0.0%
2
   6.5%
3
   2.4%
Not Hispanic or Latino
31
 100.0%
30
  96.8%
30
 100.0%
29
  93.5%
120
  97.6%
Unknown or Not Reported
0
   0.0%
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 31 participants 31 participants 30 participants 31 participants 123 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.2%
1
   3.2%
0
   0.0%
1
   3.2%
3
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  19.4%
3
   9.7%
3
  10.0%
2
   6.5%
14
  11.4%
White
24
  77.4%
27
  87.1%
27
  90.0%
28
  90.3%
106
  86.2%
More than one race
0
   0.0%
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%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks.
Hide Description An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. 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).
Time Frame Baseline, Week 8 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) (n=123) population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.
Arm/Group Title Test Product 1 Test Product 2 Reference Product 1 Reference Product 2
Hide Arm/Group Description:
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica.
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP.
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
Overall Number of Participants Analyzed 31 31 30 31
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.32  (0.090) -0.47  (0.090) -0.38  (0.091) -0.40  (0.090)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product 1, Reference Product 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6499
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.
Method of Estimation Estimation Parameter Difference of Least Mean Square
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.19 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.128
Estimation Comments [Not Specified]
Other Statistical Analysis

The reason for entering same analysis for primary and secondary is because statistical analysis was not done separately for primary outcome measure.

The decision was clinical decision at the time of protocol design.There was no comparisons for the primary objective as the main objective was to look at the rank order of the treatments in level of stain reduction after 8 weeks of treatment. This was achieved via the adjusted means and confidence intervals for the means along with plots of MLSI over time. The hypothesis was that the test products would reduce stain to a greater extent than the reference products. Two comparisons of interest were done under secondary and exploratory objectives.

Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test Product 2, Reference Product 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5680
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.33 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.128
Estimation Comments -0.33 to 0.18
2.Secondary Outcome
Title Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1)
Hide Description An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 1 and reference product 1 for 8 weeks, twice daily brushing. 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 will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time Frame Baseline, Week 8 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.
Arm/Group Title Test Product 1 vs Reference Product 1
Hide Arm/Group Description:
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica.
Overall Number of Participants Analyzed 61
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
0.06  (0.128)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product 1 vs Reference Product 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6499
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.19 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.128
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
3.Secondary Outcome
Title Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2)
Hide Description An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 2 and reference product 2 for 8 weeks, twice daily brushing. 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 will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time Frame Baseline, Week 8 post treatment administration
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.
Arm/Group Title Test Product 2 vs Reference Product 2
Hide Arm/Group Description:
Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
Overall Number of Participants Analyzed 62
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-0.07  (0.128)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product 2 vs Reference Product 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5680
Comments [Not Specified]
Method ANCOVA
Comments From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.
Method of Estimation Estimation Parameter Difference of Least Square mean
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.33 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.128
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Product 1 Test Product 2 Reference Product 1 Reference Product 2
Hide Arm/Group Description Participants were instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. Participants were instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. Participants were instructed to apply marketed dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP.
All-Cause Mortality
Test Product 1 Test Product 2 Reference Product 1 Reference Product 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/31 (0.00%)      0/30 (0.00%)      0/31 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Test Product 1 Test Product 2 Reference Product 1 Reference Product 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/31 (0.00%)      0/30 (0.00%)      0/31 (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 Test Product 2 Reference Product 1 Reference Product 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/31 (9.68%)      1/31 (3.23%)      2/30 (6.67%)      0/31 (0.00%)    
Gastrointestinal disorders         
LIP ULCERATION   1/31 (3.23%)  1 1/31 (3.23%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0
MOUTH ULCERATION   0/31 (0.00%)  0 0/31 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0
PALATAL ULCER   0/31 (0.00%)  0 0/31 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0
Infections and infestations         
ANGULAR CHEILITIS   1/31 (3.23%)  1 0/31 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0
Injury, poisoning and procedural complications         
TRAUMATIC ULCER   2/31 (6.45%)  2 0/31 (0.00%)  0 0/30 (0.00%)  0 0/31 (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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03267511     History of Changes
Other Study ID Numbers: 208078
First Submitted: August 28, 2017
First Posted: August 30, 2017
Results First Submitted: November 30, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019