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Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

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ClinicalTrials.gov Identifier: NCT01563172
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : August 10, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Dental Caries
Interventions Drug: Sodium fluoride / silica and carbopol, 0.5g
Drug: Sodium fluoride / silica and carbopol, 1.5g
Other: Fluoride free dentifrice
Enrollment 65

Recruitment Details Participants were recruited from 1 center in the USA.
Pre-assignment Details Total of 74 participants were screened for the study, out of which 65 participants were randomized in the study. Nine participants were screen failures.
Arm/Group Title Overall
Hide Arm/Group Description This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
Period Title: Overall Study
Started 65
Experimental Dentifrice 0.5g/2 Min 59
Experimental Dentifrice 0.5g/45 Sec 59
Experimental Dentifrice 1.5g/ 2min 58
Experimental Dentifrice 1.5g/ 45 Sec 58
Control Dentifrice 60
Completed 52
Not Completed 13
Reason Not Completed
Adverse Event             5
Lost to Follow-up             2
Other (Protocol deviation)             5
Other (Not specified)             1
Arm/Group Title Overall
Hide Arm/Group Description This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
Safety population: The overall Safety Population included all the participants who were randomized and used at least one of the treatment dentifrices during the study and had at least one safety assessment (e.g. assessment of adverse events [AEs] or had an oral soft tissue examination) after using the treatment dentifrices.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
63.6  (8.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
38
  58.5%
Male
27
  41.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
Caucasian 28
Black 37
1.Primary Outcome
Title Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Hide Description SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Time Frame At Baseline and at Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) population: Included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 57 53
Least Squares Mean (Standard Error)
Unit of Measure: % SMH
41.61  (2.244) 34.66  (2.284)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value 6.95
Confidence Interval (2-Sided) 95%
2.91 to 10.98
Estimation Comments

LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

2.Secondary Outcome
Title Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
Hide Description SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Time Frame At Baseline and at Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 0.5g, 45 Seconds Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 58 55
Least Squares Mean (Standard Error)
Unit of Measure: % SMH
30.75  (2.232) 25.05  (2.266)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 0.5g, 2 Minutes Brushing Group, Experimental Dentifrice 0.5g, 45 Seconds Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.70
Confidence Interval (2-Sided) 95%
1.74 to 9.66
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

3.Secondary Outcome
Title Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
Hide Description SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Time Frame At Baseline and at Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 58 57
Least Squares Mean (Standard Error)
Unit of Measure: % SMH
30.75  (2.232) 41.61  (2.244)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 0.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -10.86
Confidence Interval (2-Sided) 95%
-14.77 to -6.94
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

4.Secondary Outcome
Title Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Hide Description SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Time Frame At Baseline and at Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 0.5g, 45 Seconds Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 55 53
Least Squares Mean (Standard Error)
Unit of Measure: % SMH
25.05  (2.266) 34.66  (2.284)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 0.5g, 45 Seconds Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.61
Confidence Interval (2-Sided) 95%
-13.68 to -5.54
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

5.Secondary Outcome
Title Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.
Hide Description SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Time Frame At Baseline and at Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Contol Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice.
Overall Number of Participants Analyzed 57 58
Least Squares Mean (Standard Error)
Unit of Measure: % SMH
41.61  (2.244) 26.23  (2.232)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Contol Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 15.38
Confidence Interval (2-Sided) 95%
11.45 to 19.31
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

6.Secondary Outcome
Title Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Hide Description EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 57 53
Least Squares Mean (Standard Error)
Unit of Measure: micrograms (μg)×F/centimeters(cm)2
2426.51  (103.802) 1912.51  (106.620)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 514.01
Confidence Interval (2-Sided) 95%
283.02 to 744.99
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

7.Secondary Outcome
Title Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
Hide Description EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 0.5g, 45 Seconds Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 58 55
Least Squares Mean (Standard Error)
Unit of Measure: μg×F/cm2
1603.63  (103.018) 1337.72  (105.260)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 0.5g, 2 Minutes Brushing Group, Experimental Dentifrice 0.5g, 45 Seconds Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0218
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 265.92
Confidence Interval (2-Sided) 95%
39.00 to 492.83
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

8.Secondary Outcome
Title Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
Hide Description EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 58 57
Least Squares Mean (Standard Error)
Unit of Measure: μg×F/cm2
1603.63  (103.018) 2426.51  (103.802)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 0.5g, 2 Minutes Brushing Group, Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -822.88
Confidence Interval (2-Sided) 95%
-1047.34 to -598.42
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

9.Secondary Outcome
Title Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Hide Description EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 0.5g, 45 Seconds Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
Overall Number of Participants Analyzed 55 53
Least Squares Mean (Standard Error)
Unit of Measure: μg×F/cm2
1337.72  (105.260) 1912.51  (106.620)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 0.5g, 45 Seconds Brushing Group, Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -574.79
Confidence Interval (2-Sided) 95%
-808.08 to -341.50
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

10.Secondary Outcome
Title Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.
Hide Description EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time Frame At Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
Arm/Group Title Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Contol Group
Hide Arm/Group Description:
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of control dentifrice.
Overall Number of Participants Analyzed 57 58
Least Squares Mean (Standard Error)
Unit of Measure: μg×F/cm2
2426.51  (103.802) 1132.18  (103.044)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Dentifrice 1.5g, 2 Minutes Brushing Group, Contol Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1294.34
Confidence Interval (2-Sided) 95%
1069.24 to 1519.43
Estimation Comments

LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).

Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.

Time Frame Approximately 16 Weeks
Adverse Event Reporting Description All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
 
Arm/Group Title Experimental Dentifrice 0.5g, 45 Seconds Brushing Group Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Contol Group
Hide Arm/Group Description Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice. Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice. Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice. Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice. Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with control dentifrice.
All-Cause Mortality
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Contol Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%)   0/58 (0.00%)   0/58 (0.00%)   0/60 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Contol Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%)   0/58 (0.00%)   0/58 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group Experimental Dentifrice 0.5g, 2 Minutes Brushing Group Experimental Dentifrice 1.5g, 45 Seconds Brushing Group Experimental Dentifrice 1.5g, 2 Minutes Brushing Group Contol Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/59 (18.64%)   8/59 (13.56%)   12/58 (20.69%)   10/58 (17.24%)   10/60 (16.67%) 
Gastrointestinal disorders           
Gingival mucosa imprint from teeth 28 and 29   1/59 (1.69%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Erythema anterior hard palate   1/59 (1.69%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Gingival mucosa edentulous maxillary anterior ridge erythema   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Swelling of right inside of mouth & lip caused by biting   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Ulceration on gingival lingual 26 ~2mm (millimeter)   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Gingival mucosa cervical lingual area swollen with exudate   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Gingival mucosa erythema of right posterior edentulous ridge   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Gingival mucosa erythema left posterior edentulous ridge   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
White coating on tongue   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Sore area on ridge area #22 from partial   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Submandibular area small ulcer not painful   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Gingival mucosa erythema lingual tooth 23   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  0/60 (0.00%) 
Labial mucosa chapped lips upper & lower   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
General disorders           
Common cold   3/59 (5.08%)  2/59 (3.39%)  3/58 (5.17%)  2/58 (3.45%)  1/60 (1.67%) 
Cellulitis lower right leg   1/59 (1.69%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Sprained right ankle   1/59 (1.69%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Sinus infection   1/59 (1.69%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Kidneys infection   1/59 (1.69%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Gout   1/59 (1.69%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Felt very tired   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Back pain from arthritis   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Gout flare-up   0/59 (0.00%)  1/59 (1.69%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
Urinary tract infection   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  1/58 (1.72%)  0/60 (0.00%) 
Boil on vaginal area   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Chest pains   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Worsening of acid reflux   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Mycosis fungoides of the skin   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Seasonal allergies   0/59 (0.00%)  0/59 (0.00%)  1/58 (1.72%)  0/58 (0.00%)  0/60 (0.00%) 
Lower back pain   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  0/60 (0.00%) 
Diverticulitis   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  0/60 (0.00%) 
Sinus drainage   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  0/60 (0.00%) 
Erythema facial   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  0/60 (0.00%) 
Brown coating on tongue   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  1/60 (1.67%) 
Dizziness and vomiting   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  0/60 (0.00%) 
Broke right hip (right intertrochanteric hip fracture)   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  1/58 (1.72%)  0/60 (0.00%) 
Worsening of arthritis   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
Left eye swollen and red beneath eye   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
Stomach virus   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
Right shoulder pain   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
Infections and infestations           
Infected tooth 10   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
Injury, poisoning and procedural complications           
Thermal burn anterior hard palate   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
Crown come off tooth 9   0/59 (0.00%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders           
Sore throat left side   1/59 (1.69%)  0/59 (0.00%)  0/58 (0.00%)  0/58 (0.00%)  0/60 (0.00%) 
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
Publications of Results:
https://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563172     History of Changes
Other Study ID Numbers: T3158587
First Submitted: February 16, 2012
First Posted: March 26, 2012
Results First Submitted: April 27, 2017
Results First Posted: August 10, 2017
Last Update Posted: February 7, 2018