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NCT Number: NCT02195583

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

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.

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Key information

Conditions

Oral Hygiene

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Sodium fluoride (1426 ppm)

Drug

Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base

Sodium fluoride (1150 ppm)

Drug

Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base

Sodium fluoride (250 ppm)

Drug

Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base

Sodium fluoride (1426 ppm) + zinc base A

Drug

Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base

Sodium fluoride (1426 ppm) + zinc base B

Drug

Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base

Fluoride (0 ppm)

Drug

Non-zinc, 0ppm fluoride in a silica gel base

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2014
Registry last updated
May 1, 2015

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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