Last updated: 11/04/2018 10:26:08
A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Trial description: An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage surface microhardness recovery of test dentifrices relative to placebo dentifrice
Timeframe: Baseline to 4 hours
Secondary outcomes:
%SMHR of enamel specimens exposed to test treatments
Timeframe: Baseline to 4 hours
Percent net acid resistance (%NAR) of enamel specimens
Timeframe: Baseline to 4 hours
Enamel fluoride uptake
Timeframe: Baseline to 4 hours
Interventions:
Drug: Fluoride
Drug: Placebo
Enrollment:
55
Observational study model:
Not applicable
Primary completion date:
2012-31-05
Time perspective:
Not applicable
Clinical publications:
Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2:31-8.
Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2:31-8.
Medical condition
dental caries
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
February 2012 to May 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 14 years
Accepts healthy volunteers
Yes
- Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).
Trial location(s)
Location
Indiana University School of Dentistry
Indianapolis, IN, United States, 46202
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-31-05
Actual study completion date
2012-31-05
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
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