Phase 4
N=65
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01563172 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: 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; 34.66 % SMH — p=0.0008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium fluoride / silica and carbopol, 0.5g (Drug); Sodium fluoride / silica and carbopol, 1.5g (Drug); Fluoride free dentifrice (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 34.66 | 0.0008 sig |
| SECONDARY Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. |
30.75; 25.05 | 0.0049 sig |
| SECONDARY 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; 41.61 | <0.0001 sig |
| SECONDARY 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; 34.66 | <0.0001 sig |
| SECONDARY 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; 26.23 | <0.0001 sig |
| SECONDARY Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. |
2426.51; 1912.51 | <0.0001 sig |
| SECONDARY Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. |
1603.63; 1337.72 | 0.0218 sig |
| SECONDARY 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; 2426.51 | <0.0001 sig |
| SECONDARY 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; 1912.51 | <0.0001 sig |
| SECONDARY 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; 1132.18 | <0.0001 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
General and Dental Health
- Good general and dental health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
- Have no current active caries or periodontal disease that may compromise the study or the health of the subjects
- Residency: Currently living in the Indianapolis, Indiana area
Dentures:
- Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 mm x 7 mm)
- Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
- All restorations in a good state of repair
- Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute)
Exclusion Criteria
- Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use during the study treatment periods
- Study Scale Use: Subjects unable to measure product weights accurately using the assigned study scale as determined by the study staff (as demonstrated on or before Visit 4)
- A member of the site study staff who is directly working on the project or living in that staff's household
- Any employee of any toothpaste manufacturer or their spouse or family member
Data sourced from ClinicalTrials.gov (NCT01563172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.