Last updated: 11/04/2018 12:46:30
In situ caries of fluoride toothpastes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Comparison of the clinical efficacy from the retention phase of fluoride delivery 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:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean Percentage surface microhardness recovery (%SMHR) of enamel specimens exposed to NaF/Carbopol toothpaste (1400 ppmF), NaF toothpaste (1350ppmF) compared to NaMFP/NaF toothpaste (1450ppmF)
Timeframe: Baseline to 14 days
Secondary outcomes:
Mean %SMHR of enamel specimens exposed to NaF/Carbopol toothpaste (1400 ppmF), NaF toothpaste (1350ppmF), NaMFP/NaF toothpaste (1450ppmF), NaF toothpaste (250ppmF) and Placebo toothpaste (0ppmF)
Timeframe: Baseline to 14 days
Adjusted mean change from baseline in enamel fluoride uptake
Timeframe: Baseline to 14 days
Interventions:
Drug: Sodium fluoride toothpaste
Drug: Placebo toothpaste
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
2008-30-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, partial denture wearers, Caries
Product
fluoride
Collaborators
Not applicable
Study date(s)
November 2007 to April 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 78 years
Accepts healthy volunteers
Yes
- Inclusion Criteria
- 1. 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria 1. 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. 2. Age:Aged between 18 and 78 years. 3. Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period. 5. Diagnosis: Oral
- i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair. 6. 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 1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required. 2. Breast-feeding:Women who are breast–feeding. 3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 4. Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient. 5. Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit. 6. Fluoride:Taking fluoride supplements for medical reasons. 7. Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects. 8. Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.
Trial location(s)
No location data available.
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
2008-30-04
Actual study completion date
2008-30-04
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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