Clinical Investigation of the Transfer Accuracy of Semi-Digital and Fully Digital Indirect Bonding Trays

NCT ID: NCT07318857

Last Updated: 2026-01-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-06-24

Brief Summary

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This randomized clinical study compares the transfer accuracy of semi-digital and fully digital indirect bonding trays in orthodontic treatment. Thirty-two patients were randomly divided into two groups to receive brackets bonded with either semi-digital trays (thermoformed on 3D printed models) or fully digital trays (directly 3D printed). The primary outcome measures are linear and angular deviations between the virtually planned and actual clinical bracket positions, analyzed using 3D superimposition techniques.

Detailed Description

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Conditions

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Indirect Bonding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Semi-Digital Transfer Tray Group

Indirect bonding using transfer trays prepared by thermoforming over 3D printed models

Group Type ACTIVE_COMPARATOR

Semi-Digital Indirect Bonding

Intervention Type PROCEDURE

Bonding brackets using thermoformed transfer trays.

Fully Digital Transfer Tray Group

Indirect bonding using directly 3D printed transfer trays designed in CAD software

Group Type EXPERIMENTAL

Fully Digital Indirect Bonding

Intervention Type PROCEDURE

Bonding brackets using 3D printed transfer trays.

Interventions

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Semi-Digital Indirect Bonding

Bonding brackets using thermoformed transfer trays.

Intervention Type PROCEDURE

Fully Digital Indirect Bonding

Bonding brackets using 3D printed transfer trays.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 12-25 years in permanent dentition
* Had a mild irregularity (≤ 3mm)
* Requiring comprehensive fixed orthodontic treatment and had no previous orthodontic therapy
* Not having malformed, excessively rotated, large restorations or missing teeth in the upper arch

Exclusion Criteria

* Inadequate oral hygiene
* Had severe crowding
* Systemic or craniofacial anomalies
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Ramazan Emre Karakoç

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthodontics, Faculty of Dentistry, Selcuk University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SU-ORTO-2542

Identifier Type: -

Identifier Source: org_study_id

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