Enamel Lesion Detection With New DX Tool
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age13+
SponsorColgate Palmolive
About this trial
The primary objective of this 12-week study is to test BlueCheck's ability to identify enamel lesions consistently, and its ability to track changes in these lesions over time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Informed Consent/Assent Form.
Male and female subjects aged 13 years or older.
Availability for the duration of the study.
Good general health and good oral health based on the opinion of the study investigator.
Disqualifiers
Subjects with fixed or removable orthodontic appliances or removable partial dentures.
Obvious signs of periodontal disease or any condition that the dental examiner considers exclusionary from the study.
Cavities.
Concurrent participation in another oral clinical study.
Trial design
Design model
Single group
Treatments tested in this trial
BlueCheck
DeviceBlueCheck, a carious lesion detection formulated device, will be used to track enamel lesions for patients who are newly receiving a high fluoride toothpaste.
Prevident 5000ppm Booster Plus Toothpaste
DrugThis clinical study is testing the ability of BlueCheck to detect enamel lesions over time. In order to show changes in lesions, subjects will be prescribed Prevident 5000ppm Booster Plus Toothpaste
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Test GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Enamel Lesions per BlueCheck
Number of enamel lesions counted after using BlueCheck
Time frame
Baseline, 4 weeks, and 12 weeksSecondary outcomes
1
Self-perceived reactions to BlueCheck application
Questionnaire clinician and subject feedback on the BlueCheck application
Time frame
Baseline, 4 weeks, and 12 weeks2
Enamel Lesions per Xray
Number and location of visible enamel lesions on Xray
Time frame
Baseline, 4 weeks, and 12 weeks3
Enamel lesions per intraoral camera
Number and location of enamel lesions detected by an intraoral camera using a caries mode
Time frame
Baseline, 4 weeks, and 12 weeks4
White spots
Number and location of visible white spots per examiner's identification
Time frame
Baseline, 4 weeks, and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Colgate Palmolive
Lead sponsor
Dental Dreams, LLC
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: