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

NCT07550179 | Completed

• 1 other identifier: UoS-WSLPC-2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Removal; White Spot Lesions; Proximal Caries; Oral Hygiene in Orthodontic Patients

Keywords

Clear aligners; Fixed orthodontic appliances; White spot lesions; Proximal caries; Enamel demineralization; Professional mechanical plaque removal; Intraoral scanner; Near-infrared imaging; Caries risk assessment; Past caries experience

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline (1 week before treatment) and 6 months into treatment.

Secondary Outcomes (3)

• Behavior of Early Incident and Pre-existing White Spot Lesions

  Assessed at 3 months and 6 months.

• Frequency of Professional Mechanical Plaque Removal (PMPR)

  Up to 6 months.

• Change in Oral Hygiene Status

  Baseline and 6 months.

Study Arms (2)

Fixed labial braces group

ACTIVE COMPARATOR

Participants in this group will be treated with pre-adjusted fixed orthodontic appliances.

Device: Fixed pre-adjusted edgewise orthodontic appliance

Clear aligner group

ACTIVE COMPARATOR

Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition.

Device: Clear aligner therapy

Interventions

Fixed pre-adjusted edgewise orthodontic appliance DEVICE

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

Fixed labial braces group

Clear aligner therapy DEVICE

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

Clear aligner group

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Demographics: Patients aged 13-45 years, possessing fully erupted permanent dentition (excluding third molars).
• Malocclusion Severity: Skeletal class I according to an ANB angle of 2-4 degrees (Steiner, 1953), moderate lower malalignment of 4-9 mm based on Little's Irregularity Index, and a class I incisor relationship (British Standards Institute, 1983).
• Treatment Protocol: Comprehensive, dual-arch orthodontic treatment strictly on a non-extraction basis.
• Handover form from their referring dentist confirming absence of caries requiring restorations and that all indicated restorative therapies have been completed, in addition to no active periodontal disease or pathologic probing depths.
• No prior history of orthodontic treatment.
• No full coverage restorations (crowns/veneers) on anterior teeth or premolars.

You may not qualify if:

• Inability to maintain adequate oral hygiene prior to treatment initiation.
• Dental Anomalies and Missing Teeth: Congenitally missing teeth, presence of dental implants, or impacted teeth (excluding third molars).
• Structural Enamel Defects: Presence of developmental enamel defects that mimic or obscure demineralization, including enamel hypoplasia, fluorosis, or amelogenesis imperfecta.
• Fluoride Supplementation: Patients currently utilizing a prescribed, daily supplemental fluoride regimen beyond standard over-the-counter fluoridated toothpaste.
• Adjunctive Appliances: Treatment plans requiring the use of plaque-retentive adjunct intraoral appliances (e.g., expanders, distalizers).
• Contraindications to Therapy: Any existing biological contraindications to comprehensive orthodontic tooth movement (e.g., advanced root resorption).

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, United Arab Emirates

Location

MeSH Terms

Interventions

Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Orthodontics

Model Details: The interventional study model used in this study is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 allocation ratio between two treatment arms: clear aligners and fixed braces.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: January 8, 2024
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available once the trial is finalized up to 3 years post recruitment.
• Access Criteria: Principal investigator and researchers will have access to all IPD collected throughout the trial once it has been depersonalized.

Locations

AE (1)