Status:
COMPLETED
Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model
Lead Sponsor:
Domenick Zero
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Caries
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model involving the use ...
Detailed Description
This will be a double blind, single center, 4-way crossover design study involving 34 adult subjects, between the ages of 18 and 85 years. Two to three days before the start of each treatment period t...
Eligibility Criteria
Inclusion
- provide voluntary, written informed consent;
- be between 18 and 85 years old;
- understand and be willing, able and likely to comply with all study procedures and restrictions;
- be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 × 7 mm) and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
- be willing and capable of wearing their removable partial denture 24 hours a day for four (4), two-week treatment periods;
- be willing to allow study personnel to drill specimen sites (as described #4) in their mandibular partial denture;
- be in good medical and dental health with no active caries or periodontal disease; NOTE; subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1.
- have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).
Exclusion
- currently be pregnant, intending to become pregnant during the study period or breast feeding;
- currently have any medical condition that could be expected to interfere with the subject's safety during the study period;
- currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment 1;
- have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
- be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement;
- be taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis;
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03383783
Start Date
December 19 2017
End Date
May 2 2018
Last Update
May 20 2019
Active Locations (1)
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1
Indiana University School of Dentistry, Oral Health Research Institute
Indianapolis, Indiana, United States, 46202