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:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT04788550
Eligibility Criteria:
Inclusion Criteria:
* Subjects on multibracket fixed appliance treatment
* Subjects with 2 or more bracketed surfaces with labial subsurface WSLs from
* upper right permanent canine (13) to upper left permanent canine (23) with an ICDAS II score of 1 and 2 will be selected.
* Indicated for thermoform or vacuum formed retainers on the upper arch.
Exclusion Criteria:
* Systemic diseases or any physical anomalies.
* Subjects with intention to move out from Klang Valley area for the next 1.5 years.
* Periodontal diseases (pocket depth of more than 3mm).
* Smoker.
* Severe fluorosis or any enamel abnormalities.
* Antimicrobial agents or antibiotic therapy within the past 3 months.
* Orthognathic surgery cases, cleft lip and palate.
* Single arched lower fixed orthodontic treatment.
* Milk protein and benzoate preservatives (a common preservatives) allergies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT04788550
Study Brief:
Protocol Section:
NCT04788550