Trial · NCT01563172
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
NCT01563172, Phase 4, Completed, GlaxoSmithKline; results first posted 2017-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride. Trials, record NCT01563172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01563172
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
- NCT number
- NCT01563172
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 65 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dental Caries
- Interventions
- Sodium fluoride / silica and carbopol, 0.5g, Sodium fluoride / silica and carbopol, 1.5g, Sodium fluoride / silica and carbopol, 1.5g, Fluoride free dentifrice
- First posted
- 2012-03-26
- Last updated
- 2018-02-07
- Results first posted
- 2017-08-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | At Baseline and at Day 14 | 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. |
| Secondary | Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | At Baseline and at Day 14 | 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. |
| Secondary | 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. | At Baseline and at Day 14 | 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. |
| Secondary | 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. | At Baseline and at Day 14 | 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. |
| Secondary | 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. | At Baseline and at Day 14 | 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. |
| Secondary | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | At Day 14 | 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. |
| Secondary | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | At Day 14 | 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. |
| Secondary | 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. | At Day 14 | 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. |
| Secondary | 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. | At Day 14 | 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. |
| Secondary | 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. | At Day 14 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | At Baseline and at Day 14 | 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. | % SMH | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | At Baseline and at Day 14 | 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. | % SMH | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | At Baseline and at Day 14 | 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. | % SMH | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | At Baseline and at Day 14 | 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. | % SMH | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | At Baseline and at Day 14 | 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. | % SMH | LEAST_SQUARES_MEAN |
| SECONDARY | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | At Day 14 | 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. | micrograms (μg)×F/centimeters(cm)2 | LEAST_SQUARES_MEAN |
| SECONDARY | Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | At Day 14 | 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. | μg×F/cm2 | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | At Day 14 | 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. | μg×F/cm2 | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | At Day 14 | 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. | μg×F/cm2 | LEAST_SQUARES_MEAN |
| SECONDARY | 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. | At Day 14 | 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. | μg×F/cm2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 41.61 | Standard Error 2.244 | % SMH | |
| Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 34.66 | Standard Error 2.284 | % SMH | |
| Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 30.75 | Standard Error 2.232 | % SMH | |
| Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 25.05 | Standard Error 2.266 | % SMH | |
| 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. | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 30.75 | Standard Error 2.232 | % SMH | |
| 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. | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 41.61 | Standard Error 2.244 | % SMH | |
| 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. | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 25.05 | Standard Error 2.266 | % SMH | |
| 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. | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 34.66 | Standard Error 2.284 | % SMH | |
| 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. | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 41.61 | Standard Error 2.244 | % SMH | |
| 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. | Contol Group | 26.23 | Standard Error 2.232 | % SMH |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall | 65 | |
| Overall Study | Experimental Dentifrice 0.5g/2 Min | Overall | 59 | |
| Overall Study | Experimental Dentifrice 0.5g/45 Sec | Overall | 59 | |
| Overall Study | Experimental Dentifrice 1.5g/ 2min | Overall | 58 | |
| Overall Study | Experimental Dentifrice 1.5g/ 45 Sec | Overall | 58 | |
| Overall Study | Control Dentifrice | Overall | 60 | |
| Overall Study | COMPLETED | Overall | 52 | |
| Overall Study | NOT COMPLETED | Overall | 13 |
Source ClinicalTrials.gov
Adverse events215
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gingival mucosa imprint from teeth 28 and 29 | Gastrointestinal disorders | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 1 | 59 | |
| other | Gingival mucosa imprint from teeth 28 and 29 | Gastrointestinal disorders | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 0 | 59 | |
| other | Gingival mucosa imprint from teeth 28 and 29 | Gastrointestinal disorders | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 0 | 58 | |
| other | Gingival mucosa imprint from teeth 28 and 29 | Gastrointestinal disorders | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 0 | 58 | |
| other | Gingival mucosa imprint from teeth 28 and 29 | Gastrointestinal disorders | Contol Group | 0 | 60 | |
| other | Common cold | General disorders | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 3 | 59 | |
| other | Common cold | General disorders | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 2 | 59 | |
| other | Common cold | General disorders | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 3 | 58 | |
| other | Common cold | General disorders | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 2 | 58 | |
| other | Common cold | General disorders | Contol Group | 1 | 60 |
1 to 10 of 215Source ClinicalTrials.gov
See all 215 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 0 | 59 |
| Total, all-cause mortality | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 0 | 59 |
| Total, all-cause mortality | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 0 | 58 |
| Total, all-cause mortality | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 0 | 58 |
| Total, all-cause mortality | Contol Group | 0 | 60 |
| Total, other adverse events | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 11 | 59 |
| Total, other adverse events | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 8 | 59 |
| Total, other adverse events | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 12 | 58 |
| Total, other adverse events | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 10 | 58 |
| Total, other adverse events | Contol Group | 10 | 60 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27717756 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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