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Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563172
First received: February 16, 2012
Last updated: June 6, 2016
Last verified: June 2016

February 16, 2012
June 6, 2016
January 2009
June 2009   (final data collection date for primary outcome measure)
Change from baseline in the recovery of percentage surface micro hardness (% SMH), of brushing for 2 minutes versus (vs.) brushing for 45 seconds with 1.5 grams (g) of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
Percent SMH recovery (%SMHR) was calculated from hardness values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in vitro demineralization (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
  • Percentage surface microhardness (% SMH) recovery [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: No ]
  • enamel fluoride uptake (EFU), [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: No ]
  • percentage increase in resistance to acid demineralization (% NAR) [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01563172 on ClinicalTrials.gov Archive Site
  • Change from baseline in the recovery of % SMH, of brushing for 2 minutes vs. brushing for 45 seconds with 0.5 g of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    Percent SMH recovery (%SMHR) was calculated from hardness values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in vitro demineralization (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
  • Change from baseline in the recovery of % SMH, of brushing for 2 minutes with 0.5g of experimental dentifrice vs. brushing for 2 minutes with 1.5 g of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    Percent SMH recovery (%SMHR) was calculated from hardness values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in vitro demineralization (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
  • Change from baseline in Enamel fluoride uptake (EFU) after brushing for 45 seconds vs. brushing for 2 minutes with 1.5g of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    EFU was measured by using microdrill analysis of the enamel specimens will be carried out after 14 days of intra-oral exposure for each of the toothpaste treatments
  • Change from baseline in EFU after brushing for 45 seconds vs. brushing for 2 minutes with 0.5g of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    EFU was measured by using microdrill analysis of the enamel specimens will be carried out after 14 days of intra-oral exposure for each of the toothpaste treatments
  • Change from baseline in EFU after brushing with 0.5g of experimental dentifrice for 2 minutes vs. brushing for 2 minutes with 1.5g of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    EFU was measured by using microdrill analysis of the enamel specimens will be carried out after 14 days of intra-oral exposure for each of the toothpaste treatments
  • Change from baseline in EFU after brushing with 0.5g of experimental dentifrice for 45 seconds vs. brushing for 45 seconds with 1.5g of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    EFU was measured by using microdrill analysis of the enamel specimens will be carried out after 14 days of intra-oral exposure for each of the toothpaste treatments
  • Change from baseline in the recovery of % SMH, of brushing for 45 seconds with 0.5g of experimental dentifrice vs. brushing for 45 seconds with 1.5 g of experimental dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    Percent SMH recovery (%SMHR) was calculated from hardness values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in vitro demineralization (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
  • Change from baseline in the recovery of % SMH, of brushing for 2 minutes with 1.5g of experimental dentifrice vs. brushing for 2 minutes with 1.5 g of an control dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    Percent SMH recovery (%SMHR) was calculated from hardness values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in vitro demineralization (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
  • Change from baseline in EFU after brushing with 1.5g of experimental dentifrice for 2 minutes vs. brushing for 2 minutes with 1.5g of control dentifrice. [ Time Frame: Baseline and at 14 days ] [ Designated as safety issue: No ]
    EFU was measured by using microdrill analysis of the enamel specimens will be carried out after 14 days of intra-oral exposure for each of the toothpaste treatments
  • treatment-emergent oral soft tissue abnormalities [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: Yes ]
  • AE collection [ Time Frame: (total duration is 16 weeks) ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2009
June 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
Both
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
June 2016

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