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Trial record 10 of 32 for:    FLUORIDE ION AND NITRATE ION

In Vivo Investigation of Initial Stages of Enamel Erosion

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ClinicalTrials.gov Identifier: NCT02533466
Recruitment Status : Completed
First Posted : August 26, 2015
Results First Posted : June 15, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Tooth Erosion Other: Sodium fluoride + potassium nitrate Other: Potassium nitrate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study to Investigate the Initial Stages of Enamel Erosion in Vivo
Study Start Date : October 1, 2015
Actual Primary Completion Date : November 6, 2015
Actual Study Completion Date : November 6, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Test Product
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
Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate

Placebo Comparator: Reference Product
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
Experimental toothpaste containing 5% potassium nitrate




Primary Outcome Measures :
  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:

    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


Secondary Outcome Measures :
  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:

    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

  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:

    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

  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:

    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

  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533466


Locations
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United Kingdom
GSK Investigational Site
Bristol, United Kingdom, BS1 2LY
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02533466     History of Changes
Other Study ID Numbers: 204739
First Posted: August 26, 2015    Key Record Dates
Results First Posted: June 15, 2017
Last Update Posted: August 2, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Tooth Erosion
Tooth Wear
Tooth Diseases
Stomatognathic Diseases
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents