Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy

NCT07261735 | Recruiting

• 1 other identifier: SBU-GULHANE-ORTHO-ATTACH-2025
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clear Aligner Therapy; Aligner Attachment Wear

Keywords

Clear aligner therapy; Orthodontic attachments; Split-mouth design; Customized composites; Surface wear; Clinical survival

Outcome Measures

Primary Outcomes (1)

• 3D Surface Wear of Orthodontic Attachments

  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.

  Baseline to 6 months

Study Arms (1)

Group 1: All Participants

All participants receive four different composite materials using a randomized split-mouth design. Each quadrant is assigned one composite for attachment reproduction

Device: GC G-ænial A'Chord Universal Composite; Device: Spectra ST HV (High Viscosity); Device: Spectra ST LV (Low Viscosity); Device: GC Aligner Connect Composite

Interventions

Spectra ST HV (High Viscosity) DEVICE

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

Group 1: All Participants

GC G-ænial A'Chord Universal Composite DEVICE

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

Group 1: All Participants

Spectra ST LV (Low Viscosity) DEVICE

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

Group 1: All Participants

GC Aligner Connect Composite DEVICE

Customized composite resin specifically developed for clear aligner attachments.

Group 1: All Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals with fully erupted permanent dentition who are beginning clear aligner treatment at the Gülhane Faculty of Dentistry. Participants are enrolled prospectively after providing written informed consent for participation and for additional follow-up intraoral scans used for attachment wear analysis. Eligible patients present with mild-to-moderate crowding or spacing, show adequate oral hygiene and periodontal health, and have no prosthetic restorations or history of fixed orthodontic treatment. Patients with bruxism, high caries activity, generalized periodontal disease, poor cooperation, or buccal-surface restorations are excluded. As part of routine orthodontic care, all participants receive standardized oral hygiene instructions, including a daily tooth-brushing protocol and recommendations for toothbrush and toothpaste selection. No invasive or non-routine procedures are performed.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences, Gülhane Faculty of Dental Medicine

Ankara, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Gizem Boztaş Demir, Asst. Prof.

CONTACT

+905331518464; gizem.demir@sbu.edu.tr

Kübra Gülnur Topsakal, Assoc. Prof. Dr.

CONTACT

+905369759013; kubra.topsakal@sbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: August 25, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)