Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

GC G-ænial A'Chord Universal Composite: Universal composite resin used as the control material for attachment reproduction.

Spectra ST HV (High Viscosity): High-viscosity universal composite resin clinically used for clear aligner attachment reproduction.

Spectra ST LV (Low Viscosity): Low-viscosity universal composite resin clinically used for clear aligner attachment reproduction.

GC Aligner Connect Composite: Customized composite resin specifically developed for clear aligner attachments.

Study summary

This prospective observational clinical study aims to evaluate the three-dimensional surface wear and clinical survival of orthodontic attachments fabricated with customized composite materials used in clear aligner therapy. Attachments play a critical role in the biomechanical efficiency of aligner treatment by facilitating planned tooth movements. However, the mechanical and surface properties of the composites used for attachment fabrication may affect their wear behavior and long-term stability.

In this study, four different composite materials will be tested using a split-mouth design in patients treated with clear aligners. Each quadrant will receive a different composite, including both customized and universal types. All attachments will be fabricated using standardized digital templates and bonded under identical clinical conditions. Surface wear will be evaluated using three-dimensional optical scanning and metrology software at baseline, 1 week, 1 month, 3 months, and 6 months. Lost attachments will be replaced and recorded but excluded from wear analysis.

The results of this study are expected to provide valuable insights into the optimal material selection for clear aligner attachments, improving treatment accuracy and clinical durability.

Eligibility

Primary outcome measure(s)

• 3D Surface Wear of Orthodontic Attachments — Baseline to 6 months
  The three-dimensional surface wear of attachments will be evaluated using Zeiss Inspect software (Zeiss GmbH) by comparing baseline (T0) and follow-up scans (T1: 1 week, T2: 1 month, T3: 3 months, T4: 6 months). Wear will be quantified as total surface deviation (sigma) across the entire attachment surface and as point deviations measured at predefined corner and mid-surface points. All 3D alignments and analyses will be performed by an independent, blinded examiner who is unaware of the composite allocation for each quadrant.

Trial sites (1)

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