Trial · NCT01128946
Enamel Remineralization Potential of Dentifrices in Situ
NCT01128946, Phase 4, Completed, GlaxoSmithKline; results first posted 2013-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Enamel Remineralization Potential of Dentifrices in Situ. Trials, record NCT01128946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01128946
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enamel Remineralization Potential of Dentifrices in Situ
- NCT number
- NCT01128946
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 83 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dental Caries
- Interventions
- NaF, SnF, NaMFP
- First posted
- 2010-05-24
- Last updated
- 2015-01-01
- Results first posted
- 2013-11-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) | 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 SMH recovery 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. |
| Secondary | %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | 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 SMH recovery 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. |
| Secondary | Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | 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 | Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) | Baseline to 14 days | Per Protocol (PP) population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group. | Percentage of SMHR | MEAN |
| SECONDARY | %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | Baseline to 14 days | PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group | Percentage | MEAN |
| SECONDARY | Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | Baseline to 14 days | PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group. | micrograms (μg)*F/centimeters(cm)^2] | MEAN |
Source ClinicalTrials.gov
Results by group10
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 Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) | NaF Toothpaste (1450ppmF) | 40.94 | Standard Error 1.930 | Percentage of SMHR | |
| Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) | SnF/NaF Toothpaste (1450ppmF) | 17.88 | Standard Error 1.924 | Percentage of SMHR | |
| %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | NaF Toothpaste (1450ppmF) | 40.94 | Standard Error 1.93 | Percentage | |
| %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | NaMFP/NaF Toothpaste (1450ppmF) | 30.19 | Standard Error 1.932 | Percentage | |
| %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | SnF/NaF Toothpaste (1450ppmF) | 17.88 | Standard Error 1.924 | Percentage | |
| %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | NaF Toothpaste (675ppmF) | 28.74 | Standard Error 1.943 | Percentage | |
| Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | NaF Toothpaste (1450ppmF) | 22.23 | Standard Error 0.853 | micrograms (μg)*F/centimeters(cm)^2] | |
| Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | NaMFP/NaF Toothpaste (1450ppmF) | 13.54 | Standard Error 0.854 | micrograms (μg)*F/centimeters(cm)^2] | |
| Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | SnF/NaF Toothpaste (1450ppmF) | 9.13 | Standard Error 0.850 | micrograms (μg)*F/centimeters(cm)^2] | |
| Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) | NaF Toothpaste (675ppmF) | 14.31 | Standard Error 0.861 | micrograms (μg)*F/centimeters(cm)^2] |
Source ClinicalTrials.gov
Participant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period I | STARTED | Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F | 20 | |
| Period I | STARTED | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF | 21 | |
| Period I | STARTED | Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF | 21 | |
| Period I | STARTED | NaF Toothpaste (675ppmF | 21 | |
| Period I | COMPLETED | Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F | 20 | |
| Period I | COMPLETED | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF | 20 | |
| Period I | COMPLETED | Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF | 20 | |
| Period I | COMPLETED | NaF Toothpaste (675ppmF | 20 | |
| Period I | NOT COMPLETED | Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F | 0 | |
| Period I | NOT COMPLETED | Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events148
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 (1450ppmF) | 2 | 79 | 2 |
| other | Nasopharyngitis | Infections and infestations | NaF Toothpaste (675ppmF) | 1 | 79 | 1 |
| other | Nasopharyngitis | Infections and infestations | NaMFP/NaF Toothpaste (1450ppmF) | 3 | 80 | 3 |
| other | Nasopharyngitis | Infections and infestations | SnF/NaF Toothpaste (1450ppmF) | 3 | 80 | 4 |
| other | Gastrointestinal Viral | Infections and infestations | NaF Toothpaste (1450ppmF) | 0 | 79 | 0 |
| other | Gastrointestinal Viral | Infections and infestations | NaF Toothpaste (675ppmF) | 0 | 79 | 0 |
| other | Gastrointestinal Viral | Infections and infestations | NaMFP/NaF Toothpaste (1450ppmF) | 1 | 80 | 1 |
| other | Gastrointestinal Viral | Infections and infestations | SnF/NaF Toothpaste (1450ppmF) | 1 | 80 | 1 |
| other | Oral Herpes | Infections and infestations | NaF Toothpaste (1450ppmF) | 1 | 79 | 1 |
| other | Oral Herpes | Infections and infestations | NaF Toothpaste (675ppmF) | 1 | 79 | 1 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
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 (675ppmF) | ||
| Total, all-cause mortality | NaMFP/NaF Toothpaste (1450ppmF) | ||
| Total, all-cause mortality | SnF/NaF Toothpaste (1450ppmF) | ||
| Total, other adverse events | NaF Toothpaste (1450ppmF) | 10 | 79 |
| Total, other adverse events | NaF Toothpaste (675ppmF) | 12 | 79 |
| Total, other adverse events | NaMFP/NaF Toothpaste (1450ppmF) | 18 | 80 |
| Total, other adverse events | SnF/NaF Toothpaste (1450ppmF) | 15 | 80 |
| Total, serious adverse events | NaF Toothpaste (1450ppmF) | 0 | 79 |
| Total, serious adverse events | NaF Toothpaste (675ppmF) | 0 | 79 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT01128946
GET https://conductscience.org/api/trials/v1/NCT01128946/flow?page=2