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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02533466
Other study ID # 204739
Secondary ID
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


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
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