NCT03267914|Completed
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Sponsor study identifier
interventional
20
1 country
1
Study Start
August 29, 2017
Actual (reported)Primary Completion
November 22, 2021
Actual (reported)Study Completion
November 22, 2021
Actual (reported)Approximately 40 people will participate in this study. This study will compare two different methods of fluoride application. Both methods are currently used in dental practice and both have been shown to be effective. If the participant chooses to participate in this study, participant will be asked to either wear a small tray that has been custom made to fit into the mouth into which fluoride is placed and worn for 5 minutes at bedtime, or participant will be asked to brush fluoride onto the teeth for 2 minutes at bedtime. Participant will be randomly assigned to use one of these methods of fluoride application: participant will not be allowed to choose which method of application you prefer. Participant will be asked to use fluoride every night while enrolled in the study. The fluoride that is used in the study is approved by the United States Food and Drug Administration and is commercially available with a prescription. After the study is over, participant will need to continue to use fluoride every night for life to help reduce the risk for dental cavities in the future. During the study, participant will receive a dental examination every 3 months for a total of 4 study visits over the period of 1 year. This visit will consist of a dental examination to identify any new cavities and instructions for fluoride use. Participant will also be asked to complete a written log to document daily fluoride use and to give feedback about compliance with fluoride use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 22, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 14, 2017
Actual (reported)August 29, 2017
Actual (reported)August 31, 2017
Actual (reported)November 22, 2021
Actual (reported)November 22, 2021
Actual (reported)Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.
3 months
Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.
6 months
Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.
9 months
Dental caries incidence assessed at 4 time points
3 months
Dental caries incidence assessed clinically at 4 time points
6 months
Dental caries incidence assessed at 4 time points
9 months
Dental caries incidence assessed at 4 time points
12 months
Dental caries incidence assessed radiographically at 2 time points
6 months
Dental caries incidence assessed radiographically at 2 time points
12 months
Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.
Patients will brush with the fluoride for 2 minutes each day.
Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.
Patients will brush with the fluoride for 2 minutes each day.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
A.T. Still University, Arizona School of Dentistry & Oral Health
Mesa, Arizona, 85206, United States
Seena Patel, DMD, MPH
A.T. Still University, Arizona School of Dentistry & Oral Health
20 participants (actual enrollment reported by the registry).
First Submitted
August 14, 2017
First Posted
August 31, 2017
Study Start
Comparative Effectiveness of School-based Caries Prevention
Fluoride use compliance
To evaluate compliance, subjects will be asked about their fluoride use according to methods described by Epstein et al. (1996). High compliance is defined as daily use; low compliance is defined as two to three times per week; not compliant is defined as less than two times per week.
12 months
Contact the study team to confirm eligibility.
August 29, 2017
Primary Completion
November 22, 2021
Actual (reported)Study Completion
November 22, 2021
Actual (reported)Last Updated
November 24, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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