Last updated: 11/04/2018 12:47:10
In situ caries efficacy of fluoride toothpastes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical efficacy of fluoride toothpastes using an in situ caries model
Trial description: This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage surface microhardness recovery (%SMHR) of sound enamel specimens exposed to NaF toothpaste (1450ppmF) and NaF toothpaste (1400ppmF)
Timeframe: Baseline to 14 days
Secondary outcomes:
Percentage SMHR of sound enamel specimens exposed to NaF toothpaste (1450ppmF), NaF toothpaste (1400ppmF), NaMFP/NaF toothpaste (1450ppmF), NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF)
Timeframe: Baseline to 14 days
Percentage SMHR of demineralized enamel specimens exposed to NaF toothpaste (1450ppmF), NaF toothpaste (1400ppmF), NaF toothpaste (675ppmF), NaMFP/NaF toothpaste(1450ppmF) and Placebo toothpaste (0ppmF)
Timeframe: Baseline to 14 days
Enamel fluoride uptake (sound enamel specimens)
Timeframe: Baseline to 14 days
Enamel fluoride uptake (demineralized specimens)
Timeframe: Baseline to 14 days
Interventions:
Drug: NaF
Drug: Placebo
Drug: NaMFP
Enrollment:
57
Observational study model:
Not applicable
Primary completion date:
2008-31-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Caries
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2008 to July 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 78 years
Accepts healthy volunteers
Yes
- Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age:Aged between 18 and 80 years.
- Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding:Women who are breast-feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age:Aged between 18 and 80 years.
- Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
- Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons
- Dentures: a)Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total
- required dimensions 12 x 7 millimeter (mm) per side. b) 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
- Dental health: Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and 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 milliliter (mL)/minute; gum base stimulated whole saliva flow rate = 0.8 mL/minute)
Exclusion criteria:
- Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding:Women who are breast-feeding.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
- Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study.
- Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
- Personnel:a) A member of the site study staff living in same household.b)An employee of the sponsor. c) 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
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
2008-31-07
Actual study completion date
2008-31-07
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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