The Effectiveness of Resin-Modified Glass Ionomer Varnish in Preventing White Spot Lesions During Fixed Appliance Orthodontic Therapy

0548-18-FB

This is a prospective study to determine the effects of resin-modified glass ionomer (RMGI) on the prevention of white spot lesion (WSL) development during fixed appliance orthodontic treatment. WSLs are the beginning stages of cavity formation on teeth and RMGI is a preventative material placed on teeth. The RMGI will be applied at the initial bonding appointment when braces are put on. RMGI will be applied to some participant's teeth while others will not receive the varnish treatment. Patients will be given standardized oral hygiene instructions. At six months, the RMGI will be reapplied to the same teeth that received the original RMGI application. The development of WSLs will be assessed both by photographs and visual assessment as well as utilizing laser technology to assess the level of enamel demineralization via a dental scanner called the Canary System. Participants will be examined at 3-month intervals for a total of nine months to one year to determine if application of RMGI during fixed appliance orthodontic therapy is effective in preventing the development of WSLs.

2018-08-01

2019-04-22

2019-04-22

Withdrawn

Early phase I

Inclusion Criteria: * Willingness to participate in research project * Age ≥ 10 years old, fully erupted maxillary central and lateral incisors * treatment time with fixed appliances estimated to be at least 6 months Exclusion Criteria: * Presence of peg lateral maxillary incisors * Presence of one or more significant WSLs on maxillary incisors prior to orthodontic therapy * Restorations covering a significant portion of the labial surfaces of the maxillary incisors * Unerupted maxillary incisors, presence of uncontrolled caries * Craniofacial Syndromic patients and patients with cleft lip and/or palate * Pregnant or breast-feeding patients

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split mouth study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-08-15