Clinical trial NCT01563172: Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
Official title: A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
timeFrame: At Baseline and at Day 14
Secondary outcomes:
measure: Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
timeFrame: At Baseline and at Day 14
measure: 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.
timeFrame: At Baseline and at Day 14
measure: 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.
timeFrame: At Baseline and at Day 14
measure: 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.
timeFrame: At Baseline and at Day 14
measure: Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
timeFrame: At Day 14
measure: Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
timeFrame: At Day 14
measure: 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.
timeFrame: At Day 14
measure: 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.
timeFrame: At Day 14
measure: 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.
timeFrame: At Day 14
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: https://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1
citation: 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.