Study to Investigate the Initial Stages of Enamel Erosion in Vivo

GlaxoSmithKline1 site in 1 country30 target enrollmentOctober 1, 2015

ConditionsTooth Erosion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tooth Erosion
Sponsor: GlaxoSmithKline
Enrollment: 30
Locations: 1
Primary Endpoint: Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2015

End Date

November 6, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge

Time Frame: Baseline, 30 minutes post dietary acid challenge

The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography. The Images were graded as follows: 1. - No signs of surface erosive wear (no evidence of the "lock and key" structure) 2. - Early signs of erosive surface changes 3. - Mild signs of erosive surface changes (early signs of the "lock and key" structure). 4. - Moderate signs of erosive surface changes 5. - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable

Secondary Outcomes

Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.(Baseline, 2 hours post acid challenge)
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge(Baseline, 4 hours post acid challenge)
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge(Baseline, 7 hours post acid challenge)
Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge(Baseline, 30 mins post dietary acid challenge)
Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge(Baseline, 7 hours post dietary acid challenge)
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge(Baseline, 30 mins post dietary acid challenge)
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge(Baseline, 7 hours post dietary acid challenge)
Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge(Baseline, 30 mins post dietary acid challenge)
Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge(Baseline, 7 hours post dietary acid challenge)