Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07550179
NA

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

Sponsor: University of Sharjah

View on ClinicalTrials.gov

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.

Official title: Incidence of White Spot Lesions and Proximal Caries During Orthodontic Treatment With Fixed Pre-adjusted Edgewise Appliances Versus Clear Aligners: A Pilot Randomized Clinical Trial

Key Details

Gender

All

Age Range

13 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-01-08

Completion Date

2025-11-27

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DEVICE

Fixed pre-adjusted edgewise orthodontic appliance

Participants in this group will be treated with pre-adjusted fixed orthodontic appliances (Master Series®, American Orthodontics™, WI, USA). This system includes fixed brackets bonded on the labial surface of teeth and a sequence of progressively larger arch wires aimed at achieving alignment over time.

DEVICE

Clear aligner therapy

Participants in this group will receive clear aligners (Eon Aligner, Minneapolis, USA), designed and customized based on a digital model of each patient's dental structure. Aligners will be worn for at least 22 hours daily, and patients will change to a new aligner depending on treatment progress.

Locations (1)

University of Sharjah

Sharjah city, United Arab Emirates