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

Oral Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195583
• Other study ID #: 202194
• Secondary ID: RH02437
• Status: Completed
• Phase: N/A
• First received: July 17, 2014
• Last updated: April 9, 2015
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Hygiene

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Surface Microhardness Recovery (% SMHR)	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.	Baseline to 4 hours	No
Secondary	Enamel Fluoride Uptake	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).	Baseline to 4 hours	No
Secondary	Percentage Net Acid Resistance (% NAR)	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.	Baseline to 4 hours	No
Secondary	Percentage Comparative Acid Resistance (% CAR)	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.	Baseline to 4 hours	No