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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07318857

Enrollment

Registered

2026-01-06

Start date

2023-06-15

Completion date

2024-06-24

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indirect Bonding

Brief summary

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.

Interventions

PROCEDURESemi-Digital Indirect Bonding

Bonding brackets using thermoformed transfer trays.

PROCEDUREFully Digital Indirect Bonding

Bonding brackets using 3D printed transfer trays.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

12 Years to 25 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Linear Transfer Accuracy	Immediately after the bonding procedure (Day 1)	Linear deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software. Unit of Measure: Millimeters
Angular Transfer Accuracy	Immediately after the bonding procedure (Day 1)	Angular deviations between the virtually planned bracket positions and the actual clinical bracket positions. Measurements are calculated by superimposing the post-bonding intraoral scans onto the virtual setup models using GOM Inspect software. Unit of Measure: Degrees

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026