Back to resultsIn Vivo Investigation of Initial Stages of Enamel Erosion
Primary Purpose
Tooth Erosion
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sodium fluoride + potassium nitrate
Potassium nitrate
Sponsored by
About this trial
This is an interventional basic science trial for Tooth Erosion
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test Product
Reference Product
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining pH
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
Saliva stored at 0 - 20°C was used for determining pH
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02533466
Brief Title
In Vivo Investigation of Initial Stages of Enamel Erosion
Official Title
Study to Investigate the Initial Stages of Enamel Erosion in Vivo
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (undefined)
Primary Completion Date
November 6, 2015 (Actual)
Study Completion Date
November 6, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Erosion
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Product
Arm Type
Experimental
Arm 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.
Arm Title
Reference Product
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Sodium fluoride + potassium nitrate
Intervention Description
Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate
Intervention Type
Other
Intervention Name(s)
Potassium nitrate
Intervention Description
Experimental toothpaste containing 5% potassium nitrate
Primary Outcome Measure Information:
Title
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge
Description
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
Time Frame
Baseline, 30 minutes post dietary acid challenge
Secondary Outcome Measure Information:
Title
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.
Description
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
Time Frame
Baseline, 2 hours post acid challenge
Title
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge
Description
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
Time Frame
Baseline, 4 hours post acid challenge
Title
Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge
Description
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
Time Frame
Baseline, 7 hours post acid challenge
Title
Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge
Description
Saliva stored at 0 - 20°C was used for determining calcium concentration
Time Frame
Baseline, 30 mins post dietary acid challenge
Title
Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge
Description
Saliva stored at 0 - 20°C was used for determining calcium concentration
Time Frame
Baseline, 7 hours post dietary acid challenge
Title
Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge
Description
Saliva stored at 0 - 20°C was used for determining pH
Time Frame
Baseline, 30 mins post dietary acid challenge
Title
Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge
Description
Saliva stored at 0 - 20°C was used for determining pH
Time Frame
Baseline, 7 hours post dietary acid challenge
Title
Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge
Description
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.
Time Frame
Baseline, 30 mins post dietary acid challenge
Title
Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge
Description
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.
Time Frame
Baseline, 7 hours post dietary acid challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bristol
ZIP/Postal Code
BS1 2LY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
In Vivo Investigation of Initial Stages of Enamel Erosion
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