Clinical Trial

Labial White Spot Lesions and Proximal Caries Development in Orthodontic Patients Using Clear Aligners Versus Traditional Braces.

Completed
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Summary
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 hidden cavities between teeth 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 cleaning procedures. 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 appliance.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-17.
Trial Details
NCT Number NCT07550179
Lead Sponsor University of Sharjah
Conditions White Spot Lesions, Proximal Caries, Oral Hygiene in Orthodontic Patients, Plaque Removal
Enrollment 24 participants
Start Date 2024-01-08
Primary Completion 2025-11-27 (estimated)
Study Completion 2025-11-27 (estimated)
Updated on ClinicalTrials.gov 2026-04-30