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NCT Number: NCT07352644

Factors Affecting Attachment Loss in Clear Aligner Treatment

This prospective clinical study evaluated the incidence of composite attachment loss in patients undergoing clear aligner treatment and identified patient-, tooth-, and treatment-related factors associated with attachment debonding. Twenty-one patients were followed for six months, and attachment failures were recorded at routine visits. Outcomes were compared according to attachment type (conventional vs. optimized), attachment size, tooth type, dental arch, and patient-related factors.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

About this study

Composite attachments are integral to clear aligner therapy for improving force delivery, retention, and control of complex tooth movements. Despite their biomechanical importance, attachment loss remains a common clinical challenge and may compromise treatment efficiency and predictability. In this prospective study, attachments were bonded following the manufacturer's protocol using a high-viscosity composite. Patients were followed for six months, and attachment failures were documented with respect to type, size, tooth position, and patient-related behaviors. The primary objective was to determine the incidence of attachment loss and to identify factors associated with debonding, thereby contributing to clinical strategies that may reduce attachment failure and enhance treatment outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Permanent dentition. Mild to moderate crowding. No history of previous orthodontic treatment with fixed appliances or clear aligners

Exclusion criteria

Poor oral health. Bruxism. Crown restorations. Dental fluorosis. Enamel hypoplasia or other structural abnormalities affecting attachment bonding

Treatment and study plan

Clear Aligners with Composite Attachments

Device

Participants received clear aligner therapy (Invisalign®, Align Technology, San Jose, CA, USA). Composite attachments were bonded according to the manufacturer's protocol using a high-viscosity composite. Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated during a 6-month follow-up period.

Primary outcomes

  1. Attachment Loss Rate

    Time frame: 6 months

    Proportion of composite attachments exhibiting complete detachment or partial debonding (irregular residual composite) during routine follow-up visits. Attachment loss was assessed by direct intraoral examination and tactile verification using a dental explorer.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Factors Affecting Attachment Loss in Clear Aligner Treatment: A Prospective Clinical Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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