Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

• ClinicalTrials.gov Identifier: NCT01563172
• Recruitment Status: Completed
• First Posted: March 26, 2012
• Results First Posted: August 10, 2017
• Last Update Posted: February 7, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief 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).

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• 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
• Actual Study Start Date: January 1, 2009
• Actual Primary Completion Date: June 1, 2009
• Actual Study Completion Date: June 1, 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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 of Results:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Creeth JE, Kelly SA, Gonzalez-Cabezas C, Karwal R, Martinez-Mier EA, Lynch RJM, 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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01563172
• Other Study ID Numbers: T3158587
• First Posted: March 26, 2012
• Results First Posted: August 10, 2017
• Last Update Posted: February 7, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Listerine; Fluorides; Sodium Fluoride; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents