Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

NCT ID: NCT01563172

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2009-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental dentifrice 0.5g, 45 seconds brushing group

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

Group Type: EXPERIMENTAL

Sodium fluoride / silica and carbopol, 0.5g

Intervention Type: DRUG

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

Fluoride free dentifrice

Intervention Type: OTHER

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

Experimental dentifrice 1.5g, 45 seconds brushing group

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

Group Type: EXPERIMENTAL

Sodium fluoride / silica and carbopol, 1.5g

Intervention Type: DRUG

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

Fluoride free dentifrice

Intervention Type: OTHER

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

Experimental dentifrice 0.5g, 2 minutes brushing group

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

Group Type: EXPERIMENTAL

Sodium fluoride / silica and carbopol, 0.5g

Intervention Type: DRUG

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

Fluoride free dentifrice

Intervention Type: OTHER

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

Experimental dentifrice 1.5g, 2 minutes brushing group

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

Group Type: EXPERIMENTAL

Sodium fluoride / silica and carbopol, 1.5g

Intervention Type: DRUG

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

Fluoride free dentifrice

Intervention Type: OTHER

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

Contol group

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

Group Type: ACTIVE_COMPARATOR

Sodium fluoride / silica and carbopol, 1.5g

Intervention Type: DRUG

Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol

Fluoride free dentifrice

Intervention Type: OTHER

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

Interventions

Sodium fluoride / silica and carbopol, 0.5g

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

Intervention Type: DRUG

Sodium fluoride / silica and carbopol, 1.5g

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

Intervention Type: DRUG

Sodium fluoride / silica and carbopol, 1.5g

Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol

Intervention Type: DRUG

Fluoride free dentifrice

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Indiana University School of Dentistry

Indianapolis, Indiana, United States

Countries

United States

References

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

Reference Type: 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.

Reference Type: DERIVED

PMID: 27717756 (View on PubMed)

Other Identifiers

T3158587

Identifier Type: -

Identifier Source: org_study_id