NCT07352644

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

Keywords

ATTACHMENTATTACHMENT LOSScCLEAR ALIGNER TREATMENT

Outcome Measures

Primary Outcomes (1)

  • Attachment Loss Rate

    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.

    6 months

Study Arms (1)

Clear Aligner Treatment

EXPERIMENTAL

Participants received clear aligner therapy (Invisalign®) with composite attachments bonded according to the manufacturer's protocol. Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated over a 6-month follow-up period.

Device: Clear Aligners with Composite Attachments

Interventions

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.

Clear Aligner Treatment

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

MalocclusionCrowding

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 20, 2026

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations