In Vivo Investigation of Initial Stages of Enamel Erosion

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Tooth Erosion

Treatments: Other: Sodium fluoride + potassium nitrate; Other: Potassium nitrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02533466

204739

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Test Product

Experimental group

Description:

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.

Treatment:

Other: Sodium fluoride + potassium nitrate

Reference Product

Placebo Comparator group

Description:

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.

Treatment:

Other: Potassium nitrate