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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: July 31, 2017
Last verified: June 2017
  Purpose
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).

Condition Intervention Phase
Dental Caries Drug: Sodium fluoride / silica and carbopol, 0.5g Drug: Sodium fluoride / silica and carbopol, 1.5g Other: Fluoride free dentifrice Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 65
Actual Study Start Date: January 1, 2009
Study Completion Date: June 1, 2009
Primary Completion Date: June 1, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental dentifrice 0.5g, 45 seconds brushing group
Participants brush twice a daily for 45 seconds with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 0.5g
Dentifrice containing 1150 parts per million (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 1.5g, 45 seconds brushing group
Participants brush twice a daily for 45 seconds with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 1.5g
Dentifrice containing 1150 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, 2 minutes brushing group
Participants brush twice a daily for 2 minutes with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 0.5g
Dentifrice containing 1150 parts per million (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 1.5g, 2 minutes brushing group
Participants brush twice a daily for 2 minutes with experimental dentifrice.
Drug: Sodium fluoride / silica and carbopol, 1.5g
Dentifrice containing 1150 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
Active Comparator: Contol group
Participants brush twice a daily for 2 minutes with controll dentifrice.
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563172

Locations
United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563172     History of Changes
Other Study ID Numbers: T3158587
Study First Received: February 16, 2012
Results First Received: April 27, 2017
Last Updated: July 31, 2017

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 18, 2017