Trial · NCT01005966
In Situ Caries Model of Fluoride Toothpastes
NCT01005966, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. In Situ Caries Model of Fluoride Toothpastes. Trials, record NCT01005966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01005966
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- In Situ Caries Model of Fluoride Toothpastes
- NCT number
- NCT01005966
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 65 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Caries
- Interventions
- Sodium Fluoride Toothpaste, Amine Fluoride Toothpaste, Sodium monofluorophosphate/Sodium Fluoride Toothpaste, Placebo, 675 ppmf toothpaste
- First posted
- 2009-11-02
- Last updated
- 2013-07-29
- Results first posted
- 2013-07-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) | Baseline to 14 days | SMH recovery test was used to assess the changes in 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 rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF). |
| Secondary | Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | Baseline to 14 days | SMH test was used to assess the changes in 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 rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated. |
| Secondary | Change From Baseline in Enamel Fluoride Uptake Potential | 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
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) | Baseline to 14 days | Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population. | Percentage SMHR | MEAN |
| SECONDARY | Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | Baseline to 14 days | PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population. | Percentage SMHR | MEAN |
| SECONDARY | Change From Baseline in Enamel Fluoride Uptake Potential | Baseline to 14 days | PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population. | micrograms (μg)* F/centimeters(cm)^2 | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) | NaF Toothpaste (1426ppmF) | 38.05 | Standard Error 2.52 | Percentage SMHR | |
| Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) | AmF Toothpaste (1400ppmF) | 41.06 | Standard Error 2.53 | Percentage SMHR | |
| Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | NaF Toothpaste (1426ppmF) | 38.05 | Standard Error 2.52 | Percentage SMHR | |
| Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | AmF Toothpaste (1400ppmF) | 41.06 | Standard Error 2.53 | Percentage SMHR | |
| Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | NaMFP/NaF Toothpaste (1450ppmF) | 33.48 | Standard Error 2.49 | Percentage SMHR | |
| Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | NaF Toothpaste (675ppmF) | 29.08 | Standard Error 2.50 | Percentage SMHR | |
| Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) | Placebo Toothpaste (0ppmF) | 14.49 | Standard Error 2.48 | Percentage SMHR | |
| Change From Baseline in Enamel Fluoride Uptake Potential | NaF Toothpaste (1426ppmF) | 2342.35 | Standard Error 123.65 | micrograms (μg)* F/centimeters(cm)^2 | |
| Change From Baseline in Enamel Fluoride Uptake Potential | AmF Toothpaste (1400ppmF) | 2305.11 | Standard Error 123.83 | micrograms (μg)* F/centimeters(cm)^2 | |
| Change From Baseline in Enamel Fluoride Uptake Potential | Na MFP/NaF Toothpaste (1450ppmF) | 1809.74 | Standard Error 121.83 | micrograms (μg)* F/centimeters(cm)^2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow135
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (14 Days) | STARTED | Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F] | 13 | |
| Treatment Period 1 (14 Days) | STARTED | Amine Fluoride(AmF) Toothpaste (1400ppmF) | 13 | |
| Treatment Period 1 (14 Days) | STARTED | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) | 13 | |
| Treatment Period 1 (14 Days) | STARTED | NaF Toothpaste (675ppmF) | 13 | |
| Treatment Period 1 (14 Days) | STARTED | Placebo Toothpaste (0ppmF) | 13 | |
| Treatment Period 1 (14 Days) | COMPLETED | Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F] | 11 | |
| Treatment Period 1 (14 Days) | COMPLETED | Amine Fluoride(AmF) Toothpaste (1400ppmF) | 13 | |
| Treatment Period 1 (14 Days) | COMPLETED | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF) | 12 | |
| Treatment Period 1 (14 Days) | COMPLETED | NaF Toothpaste (675ppmF) | 13 | |
| Treatment Period 1 (14 Days) | COMPLETED | Placebo Toothpaste (0ppmF) | 13 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 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 | Nasopharyngitis | Infections and infestations | NaF Toothpaste (1426ppmF) | 1 | 57 | 1 |
| other | Nasopharyngitis | Infections and infestations | AmF Toothpaste (1400ppmF) | 5 | 57 | 5 |
| other | Nasopharyngitis | Infections and infestations | NaMFP/ NaF Toothpaste (1450ppmF) | 0 | 59 | 0 |
| other | Nasopharyngitis | Infections and infestations | NaF Toothpaste (675ppmF) | 3 | 59 | 3 |
| other | Nasopharyngitis | Infections and infestations | Placebo Toothpaste (0ppmF) | 2 | 59 | 2 |
| other | Nasopharyngitis | Infections and infestations | Overall | 10 | 65 | 11 |
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 (1426ppmF) | ||
| Total, all-cause mortality | AmF 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 (1426ppmF) | 1 | 57 |
| Total, other adverse events | AmF Toothpaste (1400ppmF) | 5 | 57 |
| Total, other adverse events | NaMFP/ NaF Toothpaste (1450ppmF) | 0 | 59 |
| Total, other adverse events | NaF Toothpaste (675ppmF) | 3 | 59 |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01005966
GET https://conductscience.org/api/trials/v1/NCT01005966/flow?page=2