Labial White Spot Lesions and Proximal Caries Development in Orthodontic Patients Using Clear Aligners Versus Traditional Braces
Summary
This ClinicalTrials.gov registration describes a randomized clinical trial (NCT07550179) comparing the development of white spot lesions and proximal caries in orthodontic patients treated with clear aligners versus traditional fixed braces. The six-month study will enroll 24 participants who will be monitored for oral health at baseline, three months, and six months using visual examinations and Near-Infrared Imaging (NIRI) technology. The trial aims to generate comparative evidence on cavity risk associated with each orthodontic appliance type to inform patient and clinician decision-making.
“The primary goal of this study is to compare how many new white spot lesions and between-the-teeth cavities develop in each group over the six-month observation period.”
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What changed
This entry is a clinical trial registration on ClinicalTrials.gov describing a randomized study comparing dental decay outcomes between clear aligner therapy and traditional fixed orthodontic braces. The study monitors 24 participants over six months for white spot lesions on tooth surfaces and proximal caries between teeth using visual examination and radiation-free Near-Infrared Imaging. Participants receive either clear aligner therapy or a fixed pre-adjusted edgewise appliance and are assessed at baseline, three months, and six months.
This is a research registry entry with no compliance obligations or regulatory implications. Clear aligner manufacturers and orthodontic practices may wish to monitor findings from this trial as they may influence future treatment recommendations and patient counseling on cavity risk during orthodontic treatment.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Labial White Spot Lesions And Proximal Caries Development In Orthodontic Patients Using Clear Aligners Versus Traditional Braces.
N/A NCT07550179 Kind: NA Apr 24, 2026
Abstract
This randomized clinical trial evaluates the risk of developing early tooth decay in patients undergoing orthodontic treatment with either traditional fixed braces or clear aligners. Because orthodontic appliances can trap plaque and make tooth cleaning difficult, patients are at a higher risk for developing early decay, such as chalky "white spot lesions" on the visible surfaces of the teeth and hidden decay between the teeth (proximal caries).
In this six-month study, 24 participants are randomly assigned to receive either fixed braces or clear aligners. Researchers will monitor the participants' oral health prior to treatment, at 3 months, and at 6 months. To safely and accurately detect decay, the study uses standard visual examinations for the front of the teeth and a radiation-free optical scanner (Near-Infrared Imaging, or NIRI) to detect hidden cavities between the teeth.
The primary goal of this study is to compare how many new white spot lesions and between-the-teeth cavities develop in each group over the six-month observation period. Additionally, the study tracks how these early lesions behave over time, monitors changes in the patients' daily oral hygiene, and records how often patients in each group require professional dental cleanings (professional mechanical plaque removal). Ultimately, this study aims to help patients and dental professionals make better-informed decisions regarding the specific cavity risks associated with each type of orthodontic app...
Conditions: White Spot Lesions, Proximal Caries, Oral Hygiene in Orthodontic Patients, Plaque Removal
Interventions: Fixed pre-adjusted edgewise orthodontic appliance, Clear aligner therapy
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