Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSaglik Bilimleri Universitesi
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
GC G-ænial A'Chord Universal Composite
DeviceUniversal composite resin used as the control material for attachment reproduction.
Spectra ST HV (High Viscosity)
DeviceHigh-viscosity universal composite resin clinically used for clear aligner attachment reproduction.
Spectra ST LV (Low Viscosity)
DeviceLow-viscosity universal composite resin clinically used for clear aligner attachment reproduction.
GC Aligner Connect Composite
DeviceCustomized composite resin specifically developed for clear aligner attachments.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Group 1: All Participants4 interventions
Trial outcomes
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.
Time frame
Baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov