The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
2 other identifiers
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 17, 2014
CompletedFirst Posted
Study publicly available on registry
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
April 7, 2015
CompletedMay 1, 2015
March 1, 2015
2 months
July 17, 2014
March 26, 2015
April 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Enamel Fluoride Uptake
Baseline to 4 hours
Percentage Net Acid Resistance (% NAR)
Baseline to 4 hours
Percentage Comparative Acid Resistance (% CAR)
Baseline to 4 hours
Study Arms (6)
Sodium fluoride (1426 ppm)
EXPERIMENTALNon-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1150 ppm)
EXPERIMENTALNon-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (250 ppm)
EXPERIMENTALNon-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base A
EXPERIMENTALZinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base B
EXPERIMENTALZinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
Fluoride (0 ppm)
PLACEBO COMPARATORNon-zinc, 0ppm fluoride in a silica gel base
Interventions
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participants taking fluoride supplement
- Pregnant or breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2014
First Posted
July 21, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
May 1, 2015
Results First Posted
April 7, 2015
Record last verified: 2015-03