Transfer accuracy of indirectly bonded brackets using the Individua® System

Transfer accuracy of indirectly bonded brackets using the Individua® System - JK-CAD/CAM

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010861

Enrollment

Registered

2016-08-11

Start date

2016-08-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Bracket Transfer accuracy

Interventions

Group 1: Transfer accuracy: transfer tray Individua® derived from intraoral scan Group 2: Transfer accuracy: transfer tray Individua® derived from dental cast made from silicone-based impression

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Full permanent dentition from second molar to second molar in both jaws 2. Informed consent

Exclusion criteria

Exclusion criteria: 1. Contraindications for fixed-appliance treatment (poor oral hygiene, severe root resorptions, patients with limited cooperation). 2. Malocclusions that prevent all brackets being bonded simultaneously. 3. Malformed or ill-structured teeth that cannot be bonded with brackets. 4. Treatment only in one jaw 5. Need for molar banding

Design outcomes

Primary

Measure	Time frame
To evaluate bracket positioning accuracy the post-bonding bracket positions in both arches will be recorded again by intraoral scanning. The deviations will be evaluated between pre- and post-bonding through virtual superimposition with a software (Geomagic Control®). Timepoint 1: First appointment of patients, dentist decides bracket placement, order Individua tray. >>> three days Timepoint 2: Individua tray fabrication, digital data export, tray sent to orthodontic department. >>> nine workdays timepoint 3: Second appointment of patients, data measurement. The whole process (timepoint 1 to 3) should not exceed four weeks. The difference between two bracket transfer methods is considered clinically significant when translational deviations exceed 0.2 mm (SD 0.04mm) or rotational deviations exceed 5°. For each bracket pair seven values in all planes and axes are obtained, including three translational values in millimeters (x, y, z, sum) and three rotational values in degrees (x, y, z).	—

Measure

Time frame

To evaluate bracket positioning accuracy the post-bonding bracket positions in both arches will be recorded again by intraoral scanning. The deviations will be evaluated between pre- and post-bonding through virtual superimposition with a software (Geomagic Control®). Timepoint 1: First appointment of patients, dentist decides bracket placement, order Individua tray. >>> three days Timepoint 2: Individua tray fabrication, digital data export, tray sent to orthodontic department. >>> nine workdays timepoint 3: Second appointment of patients, data measurement. The whole process (timepoint 1 to 3) should not exceed four weeks. The difference between two bracket transfer methods is considered clinically significant when translational deviations exceed 0.2 mm (SD 0.04mm) or rotational deviations exceed 5°. For each bracket pair seven values in all planes and axes are obtained, including three translational values in millimeters (x, y, z, sum) and three rotational values in degrees (x, y, z).

—

Secondary

Measure	Time frame
Please see Primary Outcome	—

Countries

Germany

Contacts

Public ContactPaul-Georg Jost-Brinkmann

Charité - Universitätsmedizin Berlin, CharitéCentrum 03 für Zahn-, Mund- und Kieferheilkunde

paul-g.jost-brinkmann@charite.de+49 30 450 562 522

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026