Last updated: 11/04/2018 12:46:39
Effect of dentifrice usage regime on delivery and efficacy of fluoride
GSK study ID
T3158587
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
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:
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
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
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
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
Enamel fluoride uptake (EFU) after brushing for 2 minutes vs. brushing for 45 seconds with 1.5g of experimental dentifrice.
Timeframe: At Day 14
Enamel Fluoride Uptake (EFU) after brushing for 2 minutes vs. brushing for 45 seconds with 0.5g of experimental dentifrice.
Timeframe: At Day 14
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
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
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
Interventions:
Drug: Sodium fluoride / silica and carbopol, 0.5g
Drug: Sodium fluoride / silica and carbopol, 1.5g
Other: Fluoride free dentifrice
Enrollment:
65
Observational study model:
Not applicable
Primary completion date:
2009-01-06
Time perspective:
Not applicable
Clinical publications:
https://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1
Medical condition
dental caries
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
January 2009 to June 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
Yes
- General and Dental Health
- Good general and dental health with (in the opinion of the investigator) no
- Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use
- during the study treatment periods
Inclusion and exclusion 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
Trial location(s)
Location
Indiana University School of Dentistry
Indianapolis, IN, United States, 46202
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-01-06
Actual study completion date
2009-11-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website