In Vivo Investigation of Initial Stages of Enamel Erosion

NCT02533466 | Completed Results

• 1 other identifier: 204739
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Erosion

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Baseline, 30 minutes post dietary acid challenge

Secondary Outcomes (9)

• 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

Study Arms (2)

Test Product

EXPERIMENTAL

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

Reference Product

PLACEBO COMPARATOR

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

Interventions

Sodium fluoride + potassium nitrate OTHER

Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate

Test Product

Potassium nitrate OTHER

Experimental toothpaste containing 5% potassium nitrate

Reference Product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Conditions

Tooth Erosion

Interventions

Sodium Fluoride; potassium nitrate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 26, 2015
• Study Start: October 1, 2015
• Primary Completion: November 6, 2015
• Study Completion: November 6, 2015
• Last Updated: August 2, 2017
• Results First Posted: June 15, 2017

Record last verified: 2017-03

Locations

GB (1)