Clinical trial NCT02533466: In Vivo Investigation of Initial Stages of Enamel Erosion
Official title: Study to Investigate the Initial Stages of Enamel Erosion in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Erosion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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:
measure: Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.
timeFrame: Baseline, 2 hours post acid challenge
measure: Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge
timeFrame: Baseline, 4 hours post acid challenge
measure: Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge
timeFrame: Baseline, 7 hours post acid challenge
measure: Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge
timeFrame: Baseline, 30 mins post dietary acid challenge
measure: Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge
timeFrame: Baseline, 7 hours post dietary acid challenge
measure: Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
timeFrame: Baseline, 30 mins post dietary acid challenge
measure: Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
timeFrame: Baseline, 7 hours post dietary acid challenge
measure: Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge
timeFrame: Baseline, 30 mins post dietary acid challenge
measure: Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge
timeFrame: Baseline, 7 hours post dietary acid challenge
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: