Last updated: 11/04/2018 12:47:02
Enamel Remineralization Potential of Dentifrices in situ
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Comparison of enamel remineralization potential of dentifrices incorporating different fluoride salts using an in situ caries model
Trial description: This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.
Primary purpose:
Prevention
Trial design:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage surface microhardness recovery (%SMHR) of enamel specimens exposed to NaF toothpaste (1450ppmF) and SnF/NaF toothpaste (1450ppmF)
Timeframe: Baseline to 14 days
Secondary outcomes:
%SMHR of enamel specimens exposed to NaF toothpaste (1450ppmF), SnF/NaF toothpaste (1450ppmF), NaMFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF)
Timeframe: Baseline to 14 days
Change from baseline in enamel fluoride uptake upon exposure to NaF toothpaste (1450ppmF), SnF/NaF toothpaste (1450ppmF), NaMFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF)
Timeframe: Baseline to 14 days
Interventions:
Drug: NaF
Drug: SnF
Drug: NaMFP
Enrollment:
83
Observational study model:
Not applicable
Primary completion date:
2010-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
dental caries
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
November 2009 to April 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
Yes
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
- No current active caries or periodontal disease that may compromise the study or health of the subject.
- Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
- Current active caries or periodontal disease that may compromise the study or health of the subject.
Inclusion and exclusion criteria
Inclusion criteria:
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
- No current active caries or periodontal disease that may compromise the study or health of the subject.
- All restorations in a good state of repair
- Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
- Willing to have their denture modified to accomodate enamel test specimens
- Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
- Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.
Exclusion criteria:
- Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
- Current active caries or periodontal disease that may compromise the study or health of the subject.
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
2010-31-03
Actual study completion date
2010-01-04
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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