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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00010861 |
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Date of registration:
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11/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Transfer accuracy of indirectly bonded brackets using the Individua® System
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Scientific title:
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Transfer accuracy of indirectly bonded brackets using the Individua® System - JK-CAD/CAM |
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Date of first enrolment:
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15/08/2016 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00010861 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Paul-Georg
Jost-Brinkmann |
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Address:
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Aßmannshauser Str. 4-6
14197
Berlin
Germany |
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Telephone:
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+49 30 450 562 522 |
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Email:
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paul-g.jost-brinkmann@charite.de |
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Affiliation:
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Charité - Universitätsmedizin Berlin, CharitéCentrum 03 für Zahn-, Mund- und Kieferheilkunde |
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Name:
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Paul-Georg
Jost-Brinkmann |
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Address:
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Aßmannshauser Str. 4-6
14197
Berlin
Germany |
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Telephone:
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+49 30 450 562 522 |
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Email:
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paul-g.jost-brinkmann@charite.de |
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Affiliation:
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Charité - Universitätsmedizin Berlin, CharitéCentrum 03 für Zahn-, Mund- und Kieferheilkunde |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Full permanent dentition from second molar to second molar in both jaws
2. Informed consent
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
Age minimum:
12 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bracket Transfer accuracy
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Intervention(s)
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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
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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Please see Primary Outcome
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Source(s) of Monetary Support
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CA DIGITAL GmbH
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DENTAURUM GmbH & Co. KG
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Ethics review
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Status: Approved
Approval date: 14/04/2016
Contact:
ethikkommission@charite.de
Ethikkommission der Charité – Universitätsmedizin Berlin
(+49)30-450517222
ethikkommission@charite.de
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