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Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563172
First Posted: March 26, 2012
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
February 16, 2012
March 26, 2012
April 27, 2017
August 10, 2017
September 13, 2017
January 1, 2009
June 1, 2009   (Final data collection date for primary outcome measure)
Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. [ Time Frame: At Baseline and at Day 14 ]
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.
  • Percentage surface microhardness (% SMH) recovery [ Time Frame: 2 weeks (14 days) ]
  • enamel fluoride uptake (EFU), [ Time Frame: 2 weeks (14 days) ]
  • percentage increase in resistance to acid demineralization (% NAR) [ Time Frame: 2 weeks (14 days) ]
Complete list of historical versions of study NCT01563172 on ClinicalTrials.gov Archive Site
  • Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. [ Time Frame: At Baseline and at Day 14 ]
    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.
  • 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. [ Time Frame: At Baseline and at Day 14 ]
    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.
  • 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. [ Time Frame: At Baseline and at Day 14 ]
    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.
  • 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. [ Time Frame: At Baseline and at Day 14 ]
    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.
  • Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. [ Time Frame: At Day 14 ]
    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.
  • Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice. [ Time Frame: At Day 14 ]
    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.
  • 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. [ Time Frame: At Day 14 ]
    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.
  • 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. [ Time Frame: At Day 14 ]
    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.
  • 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. [ Time Frame: At Day 14 ]
    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.
  • treatment-emergent oral soft tissue abnormalities [ Time Frame: 2 weeks (14 days) ]
  • AE collection [ Time Frame: (total duration is 16 weeks) ]
Not Provided
Not Provided
 
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Dental Caries
  • Drug: Sodium fluoride / silica and carbopol, 0.5g
    Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol
  • Drug: Sodium fluoride / silica and carbopol, 1.5g
    Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
  • Drug: 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
  • Experimental: Experimental dentifrice 0.5g, 45 seconds brushing group
    Participants brush twice a daily for 45 seconds with experimental dentifrice.
    Interventions:
    • Drug: Sodium fluoride / silica and carbopol, 0.5g
    • Other: Fluoride free dentifrice
  • Experimental: Experimental dentifrice 1.5g, 45 seconds brushing group
    Participants brush twice a daily for 45 seconds with experimental dentifrice.
    Interventions:
    • Drug: Sodium fluoride / silica and carbopol, 1.5g
    • Other: Fluoride free dentifrice
  • Experimental: Experimental dentifrice 0.5g, 2 minutes brushing group
    Participants brush twice a daily for 2 minutes with experimental dentifrice.
    Interventions:
    • Drug: Sodium fluoride / silica and carbopol, 0.5g
    • Other: Fluoride free dentifrice
  • Experimental: Experimental dentifrice 1.5g, 2 minutes brushing group
    Participants brush twice a daily for 2 minutes with experimental dentifrice.
    Interventions:
    • Drug: Sodium fluoride / silica and carbopol, 1.5g
    • Other: Fluoride free dentifrice
  • Active Comparator: Contol group
    Participants brush twice a daily for 2 minutes with controll dentifrice.
    Interventions:
    • Drug: Sodium fluoride / silica and carbopol, 1.5g
    • Other: Fluoride free dentifrice
Creeth JE, Kelly SA, González-Cabezas C, Karwal R, Martinez-Mier EA, Lynch RJ, Bosma ML, Zero DT. Effect of toothbrushing duration and dentifrice quantity on enamel remineralisation: An in situ randomized clinical trial. J Dent. 2016 Dec;55:61-67. doi: 10.1016/j.jdent.2016.10.003. Epub 2016 Oct 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 1, 2009
June 1, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01563172
T3158587
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP