In Vivo Investigation of Initial Stages of Enamel Erosion

Tooth Erosion Clinical Trial

Official title:

Study to Investigate the Intial Stages of Enamel Erosion in Vivo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533466
• Other study ID #: 204739
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: June 29, 2016
• Start date: October 2015
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 planing 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tooth Erosion

Intervention

Other:
• Sodium fluoride + potassium nitrate
Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate
• Potassium nitrate
Experimental toothpaste containing 5% potassium nitrate

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 30 minutes post dietary acid challenge	No
Secondary	Change from pre-acid challenge (baseline) tooth impression grading score following 2, 4, and 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	Upto 7 hours	No
Secondary	Change from pre-acid challenge (baseline) tooth impression grading score immediately following brushing with a fluoride toothpaste.	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. Change from Baseline in Grading Score of SEM of Tooth Impression immediately following brushing was tested for product containing fluoride only i.e. Test Product	Baseline to immediately following brushing	No
Secondary	Change from Baseline of Salivary Calcium Concentration at 30 mins and 7 hours post dietary acid challenge	Saliva stored at 0 - 20°C was used for determining calcium concentration	Upto 7 hours	No
Secondary	Change from Baseline of pH Measurement at 30 mins and 7 hours post dietary acid challenge	Saliva stored at 0 - 20°C was used for determining pH	Upto 7 hours	No
Secondary	Change from baseline of buffering ability measurement at 30 mins and 7 hours post dietary acid challenge	Saliva stored at 0 - 20°C was used for determining buffering capacity.	upto 7 hours	No