Last updated: 11/03/2018 22:45:18
In Vivo investigation of initial stages of enamel erosion
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to investigate the initial stages of enamel erosion in vivo
Trial description: This exploratory study is designed to help develop a clinical model to measure the earlier stages of dietary acid medicated enamel loss. The study will use fluoride as positive control to explore the validity of this design.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from pre-acid challenge (baseline) tooth impression grading score immediately following an acid challenge
Timeframe: Baseline, 30 minutes post dietary acid challenge
Secondary outcomes:
Change from pre-acid challenge (baseline) tooth impression grading score following 2 hours post acid challenge.
Timeframe: Baseline, 2 hours post acid challenge
Change from pre-acid challenge (baseline) tooth impression grading score following 4 hours post acid challenge
Timeframe: Baseline, 4 hours post acid challenge
Change from pre-acid challenge (baseline) tooth impression grading score following 7 hours post acid challenge
Timeframe: Baseline, 7 hours post acid challenge
Change from Baseline of Salivary Calcium Concentration at 30 mins post dietary acid challenge
Timeframe: Baseline, 30 mins post dietary acid challenge
Change from Baseline of Salivary Calcium Concentration 7 hours post dietary acid challenge
Timeframe: Baseline, 7 hours post dietary acid challenge
Change from Baseline of pH Measurement at 30 mins post dietary acid challenge
Timeframe: Baseline, 30 mins post dietary acid challenge
Change from baseline of pH measurement 7 hours post dietary acid challenge
Timeframe: Baseline, 7 hours post dietary acid challenge
Change from baseline in buffering capacity at 30 mins post dietary acid challenge
Timeframe: Baseline, 30 mins post dietary acid challenge
Change from baseline in buffering capacity 7 hours post dietary acid challenge
Timeframe: Baseline, 7 hours post dietary acid challenge
Interventions:
Other: Sodium fluoride + potassium nitrate
Other: Potassium nitrate
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
2015-06-11
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)
October 2015 to November 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 70 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 at least 18 years
- Pregnant or breast feeding women
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
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 at least 18 years
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
- Absence of any condition that would impact the participant’s safety or well-being, or affect the participant’s ability to understand and follow study procedures and requirements.
- Two anterior maxillary teeth, without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations.
Exclusion criteria:
- Pregnant or breast feeding women
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Recent history (within the last year) of alcohol or other substance abuse
- Presence of a disease or medication which in the opinion of the investigator, will impact on assessments
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening
- Surface irregularities, discoloration due to trauma, restorations and hypo or hyperplasic areas which, in the opinion of the investigator or dental assessor, would prevent accurate impressions and grading
- Daily doses of a medication which, in the opinion of the investigator, could impact the assessment, for example acidic medications
- Any condition that would impact on the subject’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2015-06-11
Actual study completion date
2015-06-11
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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