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Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later May 2026 → Dec 2026
See other at-risk trials from Saglik Bilimleri Universitesi

Record History

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  1. Notable Primary completion pushed from May 2026 to Dec 2026 Show 5 more changesShow less
    • Study completion pushed from Aug 2026 to Dec 2026
    • Interventions: GC Aligner Connect Composite (Device), GC G-ænial A'Chord Universal Composite (Device), Spectra ST HV (High Viscosity) (Device), Spectra ST… to GC Aligner Connect Composite (Device), GC G-ænial A'Chord Universal Composite (Device), Spectra ST HV (High Viscosity) (Device), Spectra ST…
    • Eligibility criteria expanded, about 15 words
    • Study description revised
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07261735
Lead Sponsor Saglik Bilimleri Universitesi
Conditions
(from sponsor)
Clear Aligner Therapy, Aligner Attachment Wear
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov