A Phase 4 interventional study of Sodium fluoride / silica and carbopol, 0.5g and Sodium fluoride / silica and carbopol, 1.5g in Dental Caries, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).
1,107 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 65 is close to the median of 60 across 915 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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General and Dental Health
Dentures:
Exclusion Criteria:
Participants brush twice a daily for 45 seconds with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 0.5g · Other: Fluoride free dentifrice
Participants brush twice a daily for 45 seconds with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 1.5g · Other: Fluoride free dentifrice
Participants brush twice a daily for 2 minutes with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 0.5g · Other: Fluoride free dentifrice
Participants brush twice a daily for 2 minutes with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 1.5g · Other: Fluoride free dentifrice
Participants brush twice a daily for 2 minutes with controll dentifrice.
Drug: Sodium fluoride / silica and carbopol, 1.5g · Other: Fluoride free dentifrice
Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol
Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
A non fluoride dentifrice was given to participants of each arm at washout period
Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Time frame: At Baseline and at Day 14
Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Time frame: At Baseline and at Day 14
Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Time frame: At Baseline and at Day 14
Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Time frame: At Baseline and at Day 14
Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Time frame: At Baseline and at Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Time frame: At Day 14
Participants were recruited from 1 center in the USA.
| Milestone | Overall |
|---|---|
| Started | 65 |
| Experimental dentifrice 0.5g/2 min | 59 |
| Experimental dentifrice 0.5g/45 sec | 59 |
| Experimental dentifrice 1.5g/ 2min | 58 |
| Experimental dentifrice 1.5g/ 45 sec | 58 |
| Control dentifrice | 60 |
| Completed | 52 |
| Not completed | 13 |
| Withdrew: Adverse event | 5 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Other (protocol deviation) | 5 |
| Withdrew: Other (not specified) | 1 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
| % SMH | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 41.61 ± 2.244 | 34.66 ± 2.284 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
| % SMH | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group |
|---|---|---|
| Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | 30.75 ± 2.232 | 25.05 ± 2.266 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
| % SMH | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group |
|---|---|---|
| Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice. | 30.75 ± 2.232 | 41.61 ± 2.244 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
| % SMH | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 25.05 ± 2.266 | 34.66 ± 2.284 |
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
| % SMH | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group |
|---|---|---|
| Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice. | 41.61 ± 2.244 | 26.23 ± 2.232 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
| micrograms (μg)×F/centimeters(cm)2 | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 2426.51 ± 103.802 | 1912.51 ± 106.620 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
| μg×F/cm2 | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group |
|---|---|---|
| Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. | 1603.63 ± 103.018 | 1337.72 ± 105.260 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
| μg×F/cm2 | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group |
|---|---|---|
| Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice. | 1603.63 ± 103.018 | 2426.51 ± 103.802 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
| μg×F/cm2 | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group |
|---|---|---|
| Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. | 1337.72 ± 105.260 | 1912.51 ± 106.620 |
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
| μg×F/cm2 | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group |
|---|---|---|
| Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice. | 2426.51 ± 103.802 | 1132.18 ± 103.044 |
Collected over Approximately 16 Weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | 0/59 (0%) | 0/59 (0%) | 11/59 (18.6%) |
| Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | 0/59 (0%) | 0/59 (0%) | 8/59 (13.6%) |
| Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | 0/58 (0%) | 0/58 (0%) | 12/58 (20.7%) |
| Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | 0/58 (0%) | 0/58 (0%) | 10/58 (17.2%) |
| Contol Group | 0/60 (0%) | 0/60 (0%) | 10/60 (16.7%) |
| Event | Experimental Dentifrice 0.5g, 45 Seconds Brushing Group | Experimental Dentifrice 0.5g, 2 Minutes Brushing Group | Experimental Dentifrice 1.5g, 45 Seconds Brushing Group | Experimental Dentifrice 1.5g, 2 Minutes Brushing Group | Contol Group |
|---|---|---|---|---|---|
| Common coldGeneral disorders | 3/59 | 2/59 | 3/58 | 2/58 | 1/60 |
| Erythema anterior hard palateGastrointestinal disorders | 1/59 | 0/59 | 1/58 | 0/58 | 0/60 |
| Gingival mucosa erythema left posterior edentulous ridgeGastrointestinal disorders | 0/59 | 0/59 | 1/58 | 0/58 | 0/60 |
| Urinary tract infectionGeneral disorders | 0/59 | 0/59 | 1/58 | 1/58 | 0/60 |
| Boil on vaginal areaGeneral disorders | 0/59 | 0/59 | 1/58 | 0/58 | 0/60 |
| White coating on tongueGastrointestinal disorders | 0/59 | 0/59 | 1/58 | 0/58 | 0/60 |
| Chest painsGeneral disorders | 0/59 | 0/59 | 1/58 | 0/58 | 0/60 |
| Worsening of acid refluxGeneral disorders | 0/59 | 0/59 | 1/58 | 0/58 | 0/60 |
| Mycosis fungoides of the skinGeneral disorders | 0/59 | 0/59 | 1/58 | 0/58 | 0/60 |
| Sore area on ridge area #22 from partialGastrointestinal disorders | 0/59 | 0/59 | 1/58 | 0/58 | 0/60 |
Safety population: The overall Safety Population included all the participants who were randomized and used at least one of the treatment dentifrices during the study and had at least one safety assessment (e.g. assessment of adverse events \[AEs\] or had an oral soft tissue examination) after using the treatment dentifrices.
| Age, Continuous(Years) | Overall |
|---|---|
| Mean | 63.6 ± 8.56 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 38 |
| Male | 27 |
| Race/Ethnicity, Customized(Participants) | Overall |
|---|---|
| Caucasian | 28 |
| Black | 37 |
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GlaxoSmithKline