Trial · NCT01657877
Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
NCT01657877, Phase 2, Completed, GlaxoSmithKline; results first posted 2014-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice. Trials, record NCT01657877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01657877
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
- NCT number
- NCT01657877
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Caries
- Interventions
- Calcium sodium phosphosilicate, Sodium monoflurophosphate, Placebo
- First posted
- 2012-08-06
- Last updated
- 2014-10-01
- Results first posted
- 2014-07-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. | Baseline to 21 days | Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. |
| Secondary | Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Baseline to 21 days | Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome. |
| Secondary | Enamel Fluoride Uptake (EFU) | Baseline to 21 days | Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Baseline to 21 days | PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. | Percentage SMHR | MEAN |
| SECONDARY | Enamel Fluoride Uptake (EFU) | Baseline to 21 days | PP population: all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group. | ppm EFU | MEAN |
| PRIMARY | Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. | Baseline to 21 days | Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. | Percentage SMHR | 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 (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | 18.72 | Standard Error 1.649 | Percentage SMHR | |
| Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | 14.74 | Standard Error 1.362 | Percentage SMHR | |
| Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP. | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | 14.01 | Standard Error 1.392 | Percentage SMHR | |
| Enamel Fluoride Uptake (EFU) | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP | 15.58 | Standard Error 0.784 | ppm EFU | |
| Enamel Fluoride Uptake (EFU) | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP | 14.85 | Standard Error 0.729 | ppm EFU | |
| Enamel Fluoride Uptake (EFU) | Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | 9.23 | Standard Error 0.440 | ppm EFU | |
| Enamel Fluoride Uptake (EFU) | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | 4.17 | Standard Error 0.241 | ppm EFU | |
| Enamel Fluoride Uptake (EFU) | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | 4.54 | Standard Error 0.291 | ppm EFU | |
| Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. | Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP | 30.15 | Standard Error 2.447 | Percentage SMHR | |
| Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. | Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP | 32.32 | Standard Error 2.673 | Percentage SMHR |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Participants | 79 | |
| Overall Study | Received 500ppm Fluoride as SMFP+ 0% CSP | Overall Participants | 70 | |
| Overall Study | Received 1500ppm Fluoride as SMFP+5% CSP | Overall Participants | 75 | |
| Overall Study | Received 0ppm Fluoride+ 5% CSP | Overall Participants | 71 | |
| Overall Study | Received 0ppm Fluoride+ 0% CSP | Overall Participants | 69 | |
| Overall Study | Received 1500ppm Fluoride as SMFP+0% CSP | Overall Participants | 71 | |
| Overall Study | COMPLETED | Overall Participants | 65 | |
| Overall Study | NOT COMPLETED | Overall Participants | 14 |
Source ClinicalTrials.gov
Adverse events245
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 | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP | 1 | 75 | 1 |
| other | Gingival erythema | Gastrointestinal disorders | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP | 1 | 71 | 1 |
| other | Gingival erythema | Gastrointestinal disorders | Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | 3 | 70 | 3 |
| other | Gingival erythema | Gastrointestinal disorders | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | 1 | 69 | 1 |
| other | Gingival erythema | Gastrointestinal disorders | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | 4 | 71 | 4 |
| other | Mouth ulceration | Gastrointestinal disorders | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP | 0 | 75 | 0 |
| other | Mouth ulceration | Gastrointestinal disorders | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP | 1 | 71 | 1 |
| other | Mouth ulceration | Gastrointestinal disorders | Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | 1 | 70 | 3 |
| other | Mouth ulceration | Gastrointestinal disorders | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | 0 | 69 | 0 |
| other | Mouth ulceration | Gastrointestinal disorders | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | 1 | 71 | 1 |
1 to 10 of 245Source ClinicalTrials.gov
See all 245 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP | ||
| Total, all-cause mortality | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP | ||
| Total, all-cause mortality | Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | ||
| Total, all-cause mortality | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | ||
| Total, all-cause mortality | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | ||
| Total, other adverse events | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP | 18 | 75 |
| Total, other adverse events | Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP | 13 | 71 |
| Total, other adverse events | Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | 14 | 70 |
| Total, other adverse events | Dentifrice Containing 0 Ppm Fluoride + 0% CSP | 11 | 69 |
| Total, other adverse events | Dentifrice Containing 0 Ppm Fluoride + 5% CSP | 13 | 71 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT01657877
GET https://conductscience.org/api/trials/v1/NCT01657877/events?page=2