Last updated: 03/04/2021 11:30:08
Intra oral kinetics of fluoride containing dentifrices
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Intra-oral kinetics of fluoride containing dentifrices in a modified saliva clearance study
Trial description: The aim of this study is to assess the impact of formulation differences on fluoride retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and comparing between treatments the concentrations of fluoride and calcium ions in saliva over 60 minutes after a single brushing with US marketed fluoridated dentifrices and following a dietary acid challenge post 60 minutes of brushing with study treatment.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Concentrations of fluoride ions in saliva 60 minutes post brushing prior to administration of the orange juice or de-ionised water rinse
Timeframe: 60 minutes
Secondary outcomes:
Concentrations of fluoride and calcium ions in saliva post brushing prior to administration of orange juice or de-ionised water rinse
Timeframe: up to 60 minutes
Concentrations of fluoride and calcium ions in saliva following administration of the orange juice or de-ionised water rinse
Timeframe: 60 minutes
Concentrations of fluoride and calcium ions in the initial expectorate, de-ionised water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse
Timeframe: up to 60 minutes
Interventions:
Other: Test Dentifrice
Other: Reference Dentifrice
Other: Comparator Dentifrice
Other: Orange Juice
Other: De-ionised water
Enrollment:
29
Observational study model:
Not applicable
Primary completion date:
2015-30-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
tooth erosion
Product
potassium nitrate, potassium nitrate/sodium fluoride, sodium fluoride
Collaborators
Not applicable
Study date(s)
September 2015 to October 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged 18-65 years
- Pregnant or breast feeding women
- Presence of chronic debilitating disease.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged 18-65 years
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or oral examination b) Absence of any condition that would impact on the participant’s safety or well being or affect the individual’s ability to understand and follow study procedures and requirements
- A minimum of 20 permanent natural teeth
- A gum-base stimulated whole saliva flow rate ≥ 0.8 mL/min and an unstimulated whole saliva flow rate ≥ 0.5 mL/min.
Exclusion criteria:
- Pregnant or breast feeding women
- Presence of chronic debilitating disease.
- Any condition that causes xerostomia as determined by the Investigator.
- Evidence of untreated caries.
- Gross periodontal disease.
- Tongue or lip piercing or presence of dental implants. Professional tooth cleaning or dental treatment during study. Oral surgery or extraction within 6 weeks of the screening visit.
- Self reported oral symptoms including lesions, sores or inflammation
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Currently taking antibiotics or have taken antibiotics within 2 weeks of the screening visit
- Any medication that could affect salivary flow or cause xerostomia as determined by the Investigator
- Use of multivitamins, calcium supplements and or fluoride supplements within 7 days of treatment phase
- Participant unwilling to abstain from smoking for at least 4 hours on the day of each test visit
- Recent history (within the last year) of alcohol or other substance abuse.
Trial location(s)
Location
GSK Investigational Site
Ellesmere Port, Cheshire, United Kingdom, CH65 4BW
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
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
2015-30-10
Actual study completion date
2015-30-10
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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