Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

NCT01563172 | Completed Phase 4 Results

• 1 other identifier: T3158587
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.

  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.

  At Baseline and at Day 14

Secondary Outcomes (9)

• Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.

  At Baseline and at Day 14

• 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.

  At Baseline and at Day 14

• 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.

  At Baseline and at Day 14

• 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.

  At Baseline and at Day 14

• Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.

  At Day 14

Study Arms (5)

Experimental dentifrice 0.5g, 45 seconds brushing group

EXPERIMENTAL

Participants brush twice a daily for 45 seconds with experimental dentifrice.

Drug: Sodium fluoride / silica and carbopol, 0.5g; Other: Fluoride free dentifrice

Experimental dentifrice 1.5g, 45 seconds brushing group

EXPERIMENTAL

Participants brush twice a daily for 45 seconds with experimental dentifrice.

Drug: Sodium fluoride / silica and carbopol, 1.5g; Other: Fluoride free dentifrice

Experimental dentifrice 0.5g, 2 minutes brushing group

EXPERIMENTAL

Participants brush twice a daily for 2 minutes with experimental dentifrice.

Drug: Sodium fluoride / silica and carbopol, 0.5g; Other: Fluoride free dentifrice

Experimental dentifrice 1.5g, 2 minutes brushing group

EXPERIMENTAL

Participants brush twice a daily for 2 minutes with experimental dentifrice.

Drug: Sodium fluoride / silica and carbopol, 1.5g; Other: Fluoride free dentifrice

Contol group

ACTIVE COMPARATOR

Participants brush twice a daily for 2 minutes with controll dentifrice.

Drug: Sodium fluoride / silica and carbopol, 1.5g; Other: Fluoride free dentifrice

Interventions

Sodium fluoride / silica and carbopol, 0.5g DRUG

Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol

Experimental dentifrice 0.5g, 2 minutes brushing group; Experimental dentifrice 0.5g, 45 seconds brushing group

Sodium fluoride / silica and carbopol, 1.5g DRUG

Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol

Experimental dentifrice 1.5g, 2 minutes brushing group; Experimental dentifrice 1.5g, 45 seconds brushing group

Fluoride free dentifrice OTHER

A non fluoride dentifrice was given to participants of each arm at washout period

Contol group; Experimental dentifrice 0.5g, 2 minutes brushing group; Experimental dentifrice 0.5g, 45 seconds brushing group; Experimental dentifrice 1.5g, 2 minutes brushing group; Experimental dentifrice 1.5g, 45 seconds brushing group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

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

  RESULT

• 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.

  PMID: 27717756 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Sodium Fluoride; Silicon Dioxide; carboxypolymethylene

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Minerals; Oxides; Oxygen Compounds; Silicon Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 26, 2012
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 7, 2018
• Results First Posted: August 10, 2017

Record last verified: 2018-01

Locations

US (1)