Trial · NCT00708097
In Situ Caries Efficacy of Fluoride Toothpastes
NCT00708097, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. In Situ Caries Efficacy of Fluoride Toothpastes. Trials, record NCT00708097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00708097
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- In Situ Caries Efficacy of Fluoride Toothpastes
- NCT number
- NCT00708097
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Caries
- Interventions
- NaF, Placebo, NaMFP
- First posted
- 2008-07-02
- Last updated
- 2015-01-01
- Results first posted
- 2013-06-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | Baseline to 14 days | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100. |
| Secondary | Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | Baseline to 14 days | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100. |
| Secondary | Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | Baseline to 14 days | SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100. |
| Secondary | Enamel Fluoride Uptake (Sound Enamel Specimens) | Baseline to 14 days | 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. The difference between treatments was calculated with respect to fluoride uptake by enamel. |
| Secondary | Enamel Fluoride Uptake (Demineralized Specimens) | Baseline to 14 days | 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. The difference between treatments was calculated with respect to fluoride uptake by enamel. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | Baseline to 14 days | Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group. | Percentage SMHR | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | Baseline to 14 days | ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group. | Percentage SMHR | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | Baseline to 14 days | ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group. | Percentage SMHR | LEAST_SQUARES_MEAN |
| SECONDARY | Enamel Fluoride Uptake (Sound Enamel Specimens) | Baseline to 14 days | ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group. | micrograms (μg)*F/centimeters(cm)^2] | LEAST_SQUARES_MEAN |
| SECONDARY | Enamel Fluoride Uptake (Demineralized Specimens) | Baseline to 14 days | ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group. | μg*F/cm^2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | NaF Toothpaste (1450ppmF) | 28.31 | Standard Error 5.54 | Percentage SMHR | |
| Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) | NaF Toothpaste (1400ppmF) | 26.32 | Standard Error 5.51 | Percentage SMHR | |
| Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | NaF/Carbopol Toothpaste(1450ppmF) | 28.31 | Standard Error 5.54 | Percentage SMHR | |
| Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | NaF Toothpaste(1400ppmF) | 26.32 | Standard Error 5.51 | Percentage SMHR | |
| Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | NaMFP/NaF Toothpaste (1450ppmF) | 26.13 | Standard Error 5.49 | Percentage SMHR | |
| Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | NaF Toothpaste (675ppmF) | 25.52 | Standard Error 5.48 | Percentage SMHR | |
| Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) | Placebo Toothpaste (0ppmF) | 53.38 | Standard Error 5.52 | Percentage SMHR | |
Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | NaF Toothpaste(1450ppmF) | 34.62 | Standard Error 2.82 | Percentage SMHR | |
Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | NaF Toothpaste(1400ppmF) | 36.06 | Standard Error 2.79 | Percentage SMHR | |
Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) | NaMFP/NaF Toothpaste (1450ppmF) | 31.12 | Standard Error 2.77 | Percentage SMHR |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F) | 11 | |
| Period 1 | STARTED | NaF Toothpaste (1400ppmF) | 12 | |
| Period 1 | STARTED | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) | 12 | |
| Period 1 | STARTED | NaF Toothpaste (675ppmF) | 11 | |
| Period 1 | STARTED | Placebo Toothpaste (0ppmF) | 11 | |
| Period 1 | COMPLETED | Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F) | 11 | |
| Period 1 | COMPLETED | NaF Toothpaste (1400ppmF) | 11 | |
| Period 1 | COMPLETED | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) | 12 | |
| Period 1 | COMPLETED | NaF Toothpaste (675ppmF) | 9 | |
| Period 1 | COMPLETED | Placebo Toothpaste (0ppmF) | 10 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 participant flowAdverse events6
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 erythema | Gastrointestinal disorders | NaF Toothpaste(1450ppmF) | 3 | 50 | 3 |
| other | Gingival erythema | Gastrointestinal disorders | NaF Toothpaste (1400ppmF) | 1 | 52 | 1 |
| other | Gingival erythema | Gastrointestinal disorders | NaMFP/NaF Toothpaste (1450ppmF) | 3 | 53 | 3 |
| other | Gingival erythema | Gastrointestinal disorders | NaF Toothpaste (675ppmF) | 4 | 53 | 4 |
| other | Gingival erythema | Gastrointestinal disorders | Placebo Toothpaste (0ppmF) | 1 | 51 | 1 |
| other | Gingival erythema | Gastrointestinal disorders | Overall | 10 | 57 | 12 |
Source ClinicalTrials.gov
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NaF Toothpaste(1450ppmF) | ||
| Total, all-cause mortality | NaF Toothpaste (1400ppmF) | ||
| Total, all-cause mortality | NaMFP/NaF Toothpaste (1450ppmF) | ||
| Total, all-cause mortality | NaF Toothpaste (675ppmF) | ||
| Total, all-cause mortality | Placebo Toothpaste (0ppmF) | ||
| Total, all-cause mortality | Overall | ||
| Total, other adverse events | NaF Toothpaste(1450ppmF) | 3 | 50 |
| Total, other adverse events | NaF Toothpaste (1400ppmF) | 1 | 52 |
| Total, other adverse events | NaMFP/NaF Toothpaste (1450ppmF) | 3 | 53 |
| Total, other adverse events | NaF Toothpaste (675ppmF) | 4 | 53 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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