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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 65
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 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)
Genders Eligible for Study:   Both
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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563172     History of Changes
Other Study ID Numbers: T3158587 
Study First Received: February 16, 2012
Last Updated: June 6, 2016
Health Authority: United States: Food and Drug Administration

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 September 30, 2016