An interventional study of Fixed pre-adjusted edgewise orthodontic appliance and Clear aligner therapy in White Spot Lesions, Proximal Caries and Oral Hygiene in Orthodontic Patients, sponsored by University of Sharjah. Completed at 1 site in United Arab Emirates. Open to participants aged 13 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Sharjah · Not applicable, Interventional, and Treatment
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.
Background and Purpose While orthodontic treatments like traditional braces and clear aligners successfully straighten teeth, they introduce a significant challenge: they make it harder to keep teeth clean. Orthodontic appliances create new areas for dental plaque and bacteria to hide, which can rapidly lead to early tooth decay. This decay typically takes two forms: white spot lesions (WSLs), which are chalky, white marks that form on the visible front surfaces of the teeth, and proximal caries, which is hidden decay that develops in the tight spaces between adjacent teeth.
Historically, it was assumed that clear aligners were a "safer" alternative to braces regarding tooth decay because they can be removed for brushing and flossing. However, clear aligners cover the teeth for 22 hours a day, preventing natural saliva from washing away food and neutralizing acids. Because of this, the actual risk of developing both visible and hidden decay associated with the two treatments required rigorous investigation.
The primary purpose of this 6-month randomized clinical trial was to directly compare the risk, incidence, and behavior of early tooth decay in patients treated with conventional fixed braces versus those treated with clear aligners.
Study Design and Participants
This study was designed as a prospective, randomized clinical trial. A total of 24 eligible adult and adolescent participants who required orthodontic treatment were randomly assigned to one of two groups:
To gain a complete picture of the patients' oral health, the research team tracked three major outcomes:
Study Timeline
Why This Study Matters This study provides highly valuable, real-world evidence for both patients and healthcare providers. By demonstrating that neither appliance is completely cavity-free, it helps orthodontists provide highly accurate, evidence-based informed consent to their patients. It reveals that while clear aligners may protect the front of the teeth better and require fewer professional cleaning procedures, they still carry a significant risk for hidden decay between the teeth. Ultimately, this study emphasizes that regardless of the appliance chosen, highly personalized, strict oral hygiene routines are mandatory to protect the teeth during orthodontic treatment.
University of Sharjah is the lead sponsor of 41 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group will be treated with pre-adjusted fixed orthodontic appliances.
Device: Fixed pre-adjusted edgewise orthodontic appliance
Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition.
Device: Clear aligner therapy
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.
Also known as: Fixed orthodontic appliance, Fixed labial braces, Conventional braces, Edgewise appliance, Straight-wire Appliance, Fixed appliance, Fixed multibracket appliance, Fixed straight-wire technique, Pre-adjusted edgewise bracket system, Fixed braces, Pre-adjusted appliance, Fixed orthodontic braces
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.
Also known as: Clear aligners, Clear aligner therapy (CAT), Eon aligner
Incidence of White Spot Lesions
The development of new (incident) white spot lesions on the labial surfaces of teeth during orthodontic treatment. Lesions are detected and classified using the visual International Caries Detection and Assessment System (ICDAS).
Time frame: Up to 6 months (assessed 1 week before treatment at baseline, then 3 months and 6 months into treatment)
Incidence of Proximal Caries
The development of new caries lesions on the interproximal surfaces of teeth (specifically premolars). Detection is performed non-invasively using Near-Infrared Imaging (NIRI) technology via an intraoral scanner.
Time frame: Baseline (1 week before treatment) and 6 months into treatment.
Behavior of Early Incident and Pre-existing White Spot Lesions
The dynamic changes (progression, regression, or stability) of white spot lesions over time. This tracks both lesions that were present prior to treatment and early incident lesions that formed within the first 3 months, evaluated using changes in their ICDAS codes.
Time frame: Assessed at 3 months and 6 months.
Frequency of Professional Mechanical Plaque Removal (PMPR)
The cumulative frequency of reactive professional mechanical plaque removal (PMPR) required by participants due to inadequate at-home plaque control. This data is extracted from the institutional electronic health records.
Time frame: Up to 6 months.
Change in Oral Hygiene Status
The changes in the participants' oral hygiene maintenance, evaluated clinically using a visual scale adapted from published literature.
Time frame: Baseline and 6 months.
Plan to share: Yes — All IPD collected throughout the trial
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Sharjah