Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy
NCT ID: NCT07261735
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
24 participants
OBSERVATIONAL
2025-08-25
2026-08-31
Brief Summary
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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.
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Detailed Description
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Four composite materials will be evaluated: GC G-ænial A'Chord (control), Spectra ST HV, Spectra ST LV, and GC Aligner Connect. Each patient will receive four different materials applied to separate quadrants following a randomized split-mouth allocation. The study planning and randomization were performed by a single researcher to ensure methodological consistency. All attachments will be fabricated using standardized digital templates based on the virtual treatment plan. The bonding procedure will be carried out by one investigator using Transbond XT adhesive and 37% phosphoric acid etching for 15 seconds.
Intraoral scanning will be performed at baseline, 1 week, 1 month, 3 months, and 6 months. The scanned data will be analyzed using Zeiss Inspect software to quantify volumetric and surface wear. All 3D alignments and superimpositions will be performed by a blinded evaluator to ensure objectivity. Lost or fractured attachments will be recorded and replaced but excluded from quantitative wear analysis.
All participants will be followed for six months. Statistical analysis will include repeated-measures ANOVA and post-hoc testing with a significance level of p \< 0.05. Reliability will be evaluated using the intraclass correlation coefficient (ICC).
This study has been approved by the Gülhane Scientific Research Ethics Committee of the University of Health Sciences (Approval No: 2024/015, August 19, 2025). The findings are expected to enhance understanding of how different composite materials influence attachment wear and longevity in clear aligner therapy, thereby improving the accuracy and clinical predictability of treatment outcomes.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
ALL
Yes
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Locations
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University of Health Sciences, Gülhane Faculty of Dental Medicine
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBU-GULHANE-ORTHO-ATTACH-2025
Identifier Type: -
Identifier Source: org_study_id
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