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The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ

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ClinicalTrials.gov Identifier: NCT02195583
Recruitment Status : Completed
First Posted : July 21, 2014
Results First Posted : April 7, 2015
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.

Condition or disease Intervention/treatment Phase
Oral Hygiene Drug: Sodium fluoride (1426 ppm) Drug: Sodium fluoride (1150 ppm) Drug: Sodium fluoride (250 ppm) Drug: Sodium fluoride (1426 ppm) + zinc base A Drug: Sodium fluoride (1426 ppm) + zinc base B Drug: Fluoride (0 ppm) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sodium fluoride (1426 ppm)
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
 Drug: Sodium fluoride (1426 ppm)
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (1150 ppm)
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
 Drug: Sodium fluoride (1150 ppm)
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (250 ppm)
Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
 Drug: Sodium fluoride (250 ppm)
Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (1426 ppm) + zinc base A
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
 Drug: Sodium fluoride (1426 ppm) + zinc base A
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (1426 ppm) + zinc base B
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
 Drug: Sodium fluoride (1426 ppm) + zinc base B
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
Placebo Comparator: Fluoride (0 ppm)
Non-zinc, 0ppm fluoride in a silica gel base
 Drug: Fluoride (0 ppm)
Non-zinc, 0ppm fluoride in a silica gel base


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Surface Microhardness Recovery (% SMHR) [ Time Frame: Baseline to 4 hours ]
    Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.


Secondary Outcome Measures :
  1. Enamel Fluoride Uptake [ Time Frame: Baseline to 4 hours ]
    The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).

  2. Percentage Net Acid Resistance (% NAR) [ Time Frame: Baseline to 4 hours ]
    Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.

  3. Percentage Comparative Acid Resistance (% CAR) [ Time Frame: Baseline to 4 hours ]
    Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
  • Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion Criteria:

  • Participants taking fluoride supplement
  • Pregnant or breast-feeding women
Contacts and Locations
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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): NCT02195583


Locations
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United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02195583    
Other Study ID Numbers: 202194
RH02437 ( Other Identifier: GSK )
First Posted: July 21, 2014    Key Record Dates
Results First Posted: April 7, 2015
Last Update Posted: May 1, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Zinc
Listerine
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
 Physiological Effects of Drugs
Trace Elements
Micronutrients
Anti-Infective Agents, Local
Anti-Infective Agents