In Vivo Investigation of Initial Stages of Enamel Erosion

Study to Investigate the Initial Stages of Enamel Erosion in Vivo

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.

Study Overview

• Status: Completed
• Conditions: Tooth Erosion
• Intervention / Treatment: Other: Sodium fluoride + potassium nitrate; Other: Potassium nitrate

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS1 2LY
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product; Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water.	Other: Sodium fluoride + potassium nitrate; Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate
Placebo Comparator: Reference Product; Subjects will apply a full ribbon of dentifrice and brush their teeth for 1 timed minute using a wetted toothbrush, swish the resulting slurry around the mouth for 30 seconds making sure it contacts the selected teeth, spit out slurry and rinse mouth for 10 seconds with water.	Other: Potassium nitrate; Experimental toothpaste containing 5% potassium nitrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an 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: - No signs of surface erosive wear (no evidence of the "lock and key" structure); - Early signs of erosive surface changes; - Mild signs of erosive surface changes (early signs of the "lock and key" structure).; - Moderate signs of erosive surface changes; - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable	Baseline, 30 minutes post dietary acid challenge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post 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: - No signs of surface erosive wear (no evidence of the "lock and key" structure); - Early signs of erosive surface changes; - Mild signs of erosive surface changes (early signs of the "lock and key" structure).; - Moderate signs of erosive surface changes; - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable	Baseline, 2 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post 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: - No signs of surface erosive wear (no evidence of the "lock and key" structure); - Early signs of erosive surface changes; - Mild signs of erosive surface changes (early signs of the "lock and key" structure).; - Moderate signs of erosive surface changes; - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable	Baseline, 4 hours post acid challenge
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post 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: - No signs of surface erosive wear (no evidence of the "lock and key" structure); - Early signs of erosive surface changes; - Mild signs of erosive surface changes (early signs of the "lock and key" structure).; - Moderate signs of erosive surface changes; - Severe signs of erosive surface changes ("lock and key" structure and enamel "pits") X - Not evaluable	Baseline, 7 hours post acid challenge
Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge	Saliva stored at 0 - 20°C was used for determining calcium concentration	Baseline, 30 mins post dietary acid challenge
Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge	Saliva stored at 0 - 20°C was used for determining calcium concentration	Baseline, 7 hours post dietary acid challenge
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge	Saliva stored at 0 - 20°C was used for determining pH	Baseline, 30 mins post dietary acid challenge
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge	Saliva stored at 0 - 20°C was used for determining pH	Baseline, 7 hours post dietary acid challenge
Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge	Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.	Baseline, 30 mins post dietary acid challenge
Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge	Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.	Baseline, 7 hours post dietary acid challenge

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): November 6, 2015
• Study Completion (Actual): November 6, 2015

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Erosion; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: 204739