RecruitingNCT07261735

Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy

Three-Dimensional Evaluation of Wear and Clinical Survival of Attachments Reproduced With Customized Composites for Clear Aligner Therapy: A Prospective Observational Clinical Study


Sponsor

Saglik Bilimleri Universitesi

Enrollment

24 participants

Start Date

Aug 25, 2025

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria5

  • Fully erupted permanent dentition.
  • No existing prosthetic restorations.
  • Mild-to-moderate dental crowding or spacing (2-6 mm).
  • Patients who are scheduled to undergo clear aligner therapy at the Department of Orthodontics, Gülhane Faculty of Dentistry, between 01.08.2025 and 01.08.2026.
  • Patients who agree to participate and provide informed consent.

Exclusion Criteria10

  • History of previous fixed orthodontic treatment.
  • Patients with poor predicted compliance or low cooperation.
  • Presence of severe or generalized periodontal disease.
  • High caries incidence or untreated caries.
  • Poor oral hygiene
  • Habitual consumption of hard foods.
  • Bruxism
  • Congenitally missing permanent teeth.
  • Dental developmental anomalies.
  • Teeth with existing composite resin restorations or ceramic crowns on buccal surfaces (which may interfere with attachment bonding or wear analysis)

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Interventions

DEVICEGC G-ænial A'Chord Universal Composite

Universal composite resin used as the control material for attachment reproduction.

DEVICESpectra ST HV (High Viscosity)

High-viscosity universal composite resin clinically used for clear aligner attachment reproduction.

DEVICESpectra ST LV (Low Viscosity)

Low-viscosity universal composite resin clinically used for clear aligner attachment reproduction.

DEVICEGC Aligner Connect Composite

Customized composite resin specifically developed for clear aligner attachments.


Locations(1)

University of Health Sciences, Gülhane Faculty of Dental Medicine

Ankara, Turkey (Türkiye)

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NCT07261735