Caries
Conditions
Brief summary
In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.
Interventions
CSP high percentage weight by weight
500 to 1500 parts per million (ppm) of fluoride
DRUGPlacebo
No CSP and no fluoride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens \[required dimensions 12 x 7 millimeters (mm)\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Enamel Fluoride Uptake (EFU) | Baseline to 21 days | Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at one clinical site (US).
Pre-assignment details
A total of 95 participants were screened, of which 79 were randomized. Of the subjects who were not randomized, 11 did not meet the study criteria; 3 had protocol violations; 2 withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were evaluated for baseline characteristics. | 79 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Other Reason | 2 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 63.5 Years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 75 | 13 / 71 | 14 / 70 | 11 / 69 | 13 / 71 |
| serious Total, serious adverse events | 1 / 75 | 0 / 71 | 2 / 70 | 0 / 69 | 0 / 71 |
Outcome results
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.
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.
Time frame: Baseline to 21 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | 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. | 30.15 Percentage SMHR | Standard Error 2.447 |
| Dentifrice Containing 0 Ppm Fluoride + 0% CSP | 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. | 32.32 Percentage SMHR | Standard Error 2.673 |
Comparison: The null hypothesis states that the population mean for the 1500 ppm fluoride as SMFP + 0% CSP minus the population mean for the 1500 ppm fluoride as SMFP and 5% CSP dentifrice is more than 6 %.p-value: 0.260195% CI: [-6.11, 1.66]ANOVA
Secondary
Enamel Fluoride Uptake (EFU)
Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.
Time frame: Baseline to 21 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | Enamel Fluoride Uptake (EFU) | 15.58 ppm EFU | Standard Error 0.784 |
| Dentifrice Containing 0 Ppm Fluoride + 0% CSP | Enamel Fluoride Uptake (EFU) | 14.85 ppm EFU | Standard Error 0.729 |
| Dentifrice Containing 0 Ppm Fluoride + 5% CSP | Enamel Fluoride Uptake (EFU) | 9.23 ppm EFU | Standard Error 0.44 |
| Dentifrice Containing 0 Ppm Fluoride + 0% CSP | Enamel Fluoride Uptake (EFU) | 4.17 ppm EFU | Standard Error 0.241 |
| Dentifrice Containing 0 Ppm Fluoride + 5% CSP | Enamel Fluoride Uptake (EFU) | 4.54 ppm EFU | Standard Error 0.291 |
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.
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.
Time frame: Baseline to 21 days
Population: PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP | 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. | 18.72 Percentage SMHR | Standard Error 1.649 |
| Dentifrice Containing 0 Ppm Fluoride + 0% CSP | 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. | 14.74 Percentage SMHR | Standard Error 1.362 |
| Dentifrice Containing 0 Ppm Fluoride + 5% CSP | 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. | 14.01 Percentage SMHR | Standard Error 1.392 |