Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

Dental Caries Clinical Trial

Official title:

A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563172
• Other study ID #: T3158587
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2012
• Last updated: January 11, 2018
• Start date: January 1, 2009
• Est. completion date: June 1, 2009

Study information

• Verified date: January 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 1, 2009
• Est. primary completion date: June 1, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Sodium fluoride / silica and carbopol, 0.5g
Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol
• Sodium fluoride / silica and carbopol, 1.5g
Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
• Sodium fluoride / silica and carbopol, 1.5g
Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol

Other:
• Fluoride free dentifrice
A non fluoride dentifrice was given to participants of each arm at washout period

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

https://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Baseline and at Day 14
Secondary	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.	At Baseline and at Day 14
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.	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.	At Baseline and at Day 14
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.	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.	At Baseline and at Day 14
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.	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.	At Baseline and at Day 14
Secondary	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.	At Day 14
Secondary	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.	At Day 14
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.	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.	At Day 14
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.	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.	At Day 14
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.	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.	At Day 14