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

Not Applicable

Completed

• Conditions: Oral Hygiene
• Interventions: Drug: Sodium fluoride (250 ppm); Drug: Sodium fluoride (1150 ppm); Drug: Sodium fluoride (1426 ppm) + zinc base A; Drug: Sodium fluoride (1426 ppm); Drug: Fluoride (0 ppm); Drug: Sodium fluoride (1426 ppm) + zinc base B

• Registration Number: NCT02195583
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-03
• Results First Submitted: 2015-03-26
• Results First Submitted QC: 2015-03-26
• Results First Posted: 2015-04-07
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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Exclusion Criteria

• Participants taking fluoride supplement
• Pregnant or breast-feeding women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sodium fluoride (250 ppm)	Sodium fluoride (250 ppm)	Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1150 ppm)	Sodium fluoride (1150 ppm)	Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base A	Sodium fluoride (1426 ppm) + zinc base A	Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm)	Sodium fluoride (1426 ppm)	Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Fluoride (0 ppm)	Fluoride (0 ppm)	Non-zinc, 0ppm fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base B	Sodium fluoride (1426 ppm) + zinc base B	Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base

Primary Outcome Measures

Name	Time	Method
Percentage Surface Microhardness Recovery (% SMHR)	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

Name	Time	Method
Percentage Comparative Acid Resistance (% CAR)	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.
Enamel Fluoride Uptake	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).
Percentage Net Acid Resistance (% NAR)	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Indianapolis, Indiana, United States