Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT01059058
Eligibility Criteria:
Inclusion Criteria:
* Completed fixed appliance orthodontic therapy within the past two years
* Have at least one white spot lesion on the facial surface of a maxillary central or lateral incisor tooth that was not present prior to treatment with fixed orthodontic appliances.
* Between the ages of 12 and 20 years of age
* Agrees to randomization to the different treatment protocols
* Signed informed consent obtained from a parent or guardian of the patient f the patient is under the age of eighteen
Exclusion Criteria:
* Not willing to be randomly assigned to one of the three treatment groups
* Any abnormal oral, medical, or mental conditions, including any milk-related allergies and/or any medical conditions involving the kidneys.
* Any patients who underwent therapy for white spot lesion after completion of orthodontic treatment
* Any white spot lesion present on qualifying teeth with frank cavitation
* Patient is non-English speaking or non-English reading
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
20 Years
Study:
NCT01059058
Study Brief:
Protocol Section:
NCT01059058