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Trial record 18 of 32 for:    FLUORIDE ION AND NITRATE ION

Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

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: NCT00752089
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dental Erosion
Interventions Drug: NaF/ KNO3/isopentane Dentifrice
Drug: NaF/KNO3 Dentifrice
Drug: NaF Dentifrice
Other: Placebo Dentifrice
Enrollment 20
Recruitment Details Participants were recruited at the clinical site.
Pre-assignment Details Two to three days before the start of each treatment period participants got their teeth cleaned to remove all accessible plaque and calculus, and were provided with a fluoride free dentifrice for maintaining wash-out period and standardizing the oral conditions.
Arm/Group Title Overall Study
Hide Arm/Group Description This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
Period Title: Overall Study
Started 20
Received NaF/ KNO3/ 2% Isopentane 19
Received NaF/KNO3/ 0% Isopentane 17
Received NaF 18
Received Placebo 18
Completed 14
Not Completed 6
Reason Not Completed
Adverse Event             1
Protocol Deviation             2
Could not attend visit 9             1
Not capable of wearing partial denture             1
Cannot continue the study             1
Arm/Group Title Overall Study Participants
Hide Arm/Group Description All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
65.31  (8.226)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens
Hide Description SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the "n" per treatment group.
Arm/Group Title NaF/ KNO3/ 2% Isopentane Dentifrice NaF/KNO3/ 0% Isopentane Dentifrice NaF Dentifrice Placebo Dentifrice
Hide Arm/Group Description:
Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Overall Number of Participants Analyzed 17 17 17 18
Least Squares Mean (95% Confidence Interval)
Unit of Measure: % SMHR
39.46
(31.17 to 47.75)
38.31
(30.00 to 46.62)
36.17
(27.89 to 44.44)
17.26
(9.08 to 25.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF/ KNO3/ 2% Isopentane Dentifrice, NaF/KNO3/ 0% Isopentane Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7756
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.146
Confidence Interval (2-Sided) 95%
-6.904 to 9.196
Estimation Comments Difference is 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 NaF/ KNO3/ 2% Isopentane Dentifrice, NaF Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4194
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.291
Confidence Interval (2-Sided) 95%
-4.840 to 11.421
Estimation Comments Difference is 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 NaF/ KNO3/ 2% Isopentane Dentifrice, Placebo Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 22.200
Confidence Interval (2-Sided) 95%
14.280 to 30.120
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NaF/KNO3/ 0% Isopentane Dentifrice, NaF Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5927
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2.145
Confidence Interval (2-Sided) 95%
-5.874 to 10.164
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NaF/KNO3/ 0% Isopentane Dentifrice, Placebo Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 21.054
Confidence Interval (2-Sided) 95%
13.189 to 28.919
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice, Placebo Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustment for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 18.909
Confidence Interval (2-Sided) 95%
11.036 to 26.783
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
2.Secondary Outcome
Title Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
Hide Description Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
PP population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the "n" per treatment group.
Arm/Group Title NaF/ KNO3/ 2% Isopentane Dentifrice NaF/ KNO3/ 0% Isopentane Dentifrice NaF Dentifrice Placebo Dentifrice
Hide Arm/Group Description:
Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Overall Number of Participants Analyzed 17 17 17 18
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ug*F/cm^3
2445.86
(1926.90 to 2694.82)
2767.30
(2247.10 to 3287.50)
2518.54
(2000.28 to 3036.80)
661.18
(148.91 to 1173.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NaF/ KNO3/ 2% Isopentane Dentifrice, NaF/ KNO3/ 0% Isopentane Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1990
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -321.438
Confidence Interval (2-Sided) 95%
-818.118 to 175.242
Estimation Comments Difference is 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 NaF/ KNO3/ 2% Isopentane Dentifrice, NaF Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7718
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -72.680
Confidence Interval 95%
-574.398 to 429.039
Estimation Comments Difference is 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 NaF/ KNO3/ 2% Isopentane Dentifrice, Placebo Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1784.675
Confidence Interval 95%
1296.044 to 2273.306
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection NaF/ KNO3/ 0% Isopentane Dentifrice, NaF Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3164
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included tratment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 248.758
Confidence Interval 95%
-245.962 to 743.478
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection NaF/ KNO3/ 0% Isopentane Dentifrice, Placebo Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period as fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 2106.113
Confidence Interval (2-Sided) 95%
1620.906 to 2591.320
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection NaF Dentifrice, Placebo Dentifrice
Comments Null hypothesis was no difference between treatments. Tests were 2-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments for multiple comparisons were made as the primary comparison was pre-defined.
Method ANOVA
Comments The model included treatment and period and fixed and participant as random factors.
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1857.355
Confidence Interval (2-Sided) 95%
1371.637 to 2343.072
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Time Frame Up to 13 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NaF/ KNO3/ 2 % Isopentane Dentifrice NaF/KNO3/ 0% Isopentane Dentifrice NaF Dentifrice Placebo Dentifrice
Hide Arm/Group Description Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane. Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
All-Cause Mortality
NaF/ KNO3/ 2 % Isopentane Dentifrice NaF/KNO3/ 0% Isopentane Dentifrice NaF Dentifrice Placebo Dentifrice
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NaF/ KNO3/ 2 % Isopentane Dentifrice NaF/KNO3/ 0% Isopentane Dentifrice NaF Dentifrice Placebo Dentifrice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/17 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NaF/ KNO3/ 2 % Isopentane Dentifrice NaF/KNO3/ 0% Isopentane Dentifrice NaF Dentifrice Placebo Dentifrice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      3/17 (17.65%)      4/18 (22.22%)      2/18 (11.11%)    
Gastrointestinal disorders         
Gingival erythema  0/17 (0.00%)  0 1/17 (5.88%)  2 2/18 (11.11%)  2 0/18 (0.00%)  0
Gingival ulceration  0/17 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
Food poisoning  0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Tongue coated  0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations         
Localised infection  1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Nasopharyngitis  0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Tooth infection  1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Injury, poisoning and procedural complications         
Tooth fracture  0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00752089     History of Changes
Other Study ID Numbers: Z3120510
First Submitted: September 11, 2008
First Posted: September 15, 2008
Results First Submitted: September 7, 2011
Results First Posted: December 8, 2016
Last Update Posted: December 8, 2016