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Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

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ClinicalTrials.gov Identifier: NCT02436473
Recruitment Status : Withdrawn (This study was cancelled. No subjects were enrolled and no data has been collected)
First Posted : May 6, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Toothpaste containing 1150ppm F Other: Toothpaste containing 0ppm F Drug: Toothpaste containing 250ppm F Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
Study Start Date : December 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Test fluoride toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods
Drug: Toothpaste containing 1150ppm F
US marketed toothpaste containing 1150ppm of F

Placebo Comparator: Fluoride free (0ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Other: Toothpaste containing 0ppm F
Experimental toothpaste containing 0ppm F

Active Comparator: Low dose fluoride (250ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Drug: Toothpaste containing 250ppm F
Experimental toothpaste containing 250ppm F

Active Comparator: Fluoride (1150ppm F) reference control toothpaste
Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods.
Drug: Toothpaste containing 1150ppm F
Experimental toothpaste containing 1150ppm F




Primary Outcome Measures :
  1. Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste [ Time Frame: 4 weeks ]
    The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)


Secondary Outcome Measures :
  1. Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments [ Time Frame: 4 weeks ]
    The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)

  2. Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments [ Time Frame: 4 weeks ]
    The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth)

  3. Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments [ Time Frame: 4 weeks ]
    The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Demonstrates understanding of the study.
  2. Aged 18 to 85 years.
  3. Understands and is willing, able and likely to comply with all study procedures and restrictions.
  4. Has good general health (in the opinion of the investigator or medically qualified designee).
  5. Currently living in the Indianapolis, Indiana area.
  6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
  7. Have no current active caries or periodontal disease and all restorations in a good state of repair.
  8. Have a salivary flow rate in the range of normal values.

Exclusion Criteria:

  1. Pregnant or breast feeding women.
  2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
  3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
  4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
  5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
  7. Recent history (within the last year) of alcohol or other substance abuse.

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): NCT02436473


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02436473     History of Changes
Other Study ID Numbers: 203161
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs