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Completed

NCT Number: NCT02533466

In Vivo Investigation of Initial Stages of Enamel Erosion

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.

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Key information

Conditions

Tooth Erosion Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Wear

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Bristol, BS1 2LY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium fluoride + potassium nitrate

Other

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

Potassium Nitrate

Other

Experimental toothpaste containing 5% potassium nitrate

Primary outcomes

  1. Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge

    Time frame: Baseline, 30 minutes post dietary 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 outcomes

  1. Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.

    Time frame: Baseline, 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

  2. Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge

    Time frame: Baseline, 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

  3. Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge

    Time frame: Baseline, 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

  4. Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge

    Time frame: Baseline, 30 mins post dietary acid challenge

    Saliva stored at 0 - 20°C was used for determining calcium concentration

  5. Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge

    Time frame: Baseline, 7 hours post dietary acid challenge

    Saliva stored at 0 - 20°C was used for determining calcium concentration

  6. Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge

    Time frame: Baseline, 30 mins post dietary acid challenge

    Saliva stored at 0 - 20°C was used for determining pH

  7. Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge

    Time frame: Baseline, 7 hours post dietary acid challenge

    Saliva stored at 0 - 20°C was used for determining pH

  8. Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge

    Time frame: Baseline, 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.

  9. Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study to Investigate the Initial Stages of Enamel Erosion in Vivo

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2015
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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