Transfer accuracy of indirectly bonded brackets using the Individua® System
Organizational Data
- DRKS-ID:
- DRKS00010861
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2016-08-11
- Last update in DRKS:
- 2016-08-11
- Registration type:
- Prospective
Acronym/abbreviation of the study
JK-CAD/CAM
URL of the study
No Entry
Brief summary in lay language
There are two ways to place orthodontic brackets: Direct bonding (DB) and indirect bonding (IDB). The latter has the advantage of offering more comfort and for the patient more precise bracket positioning. IDB has been around for years; however, it requires extra laboratory work. Now orthodontists are offered a transfer tray based on computer-aided design and manufacturing (CAD/CAM) transfer tray to bond orthodontic braces. Our goal is to investigate whether this new technology improves the precision of bracket placement in patients with full permanent dentition. The aim is to compare bracket transfer accuracy of CAD/CAM-based IDB (Individua®) with conventional IDB described by Nedwed et al. [1](Aim 1). We will also investigate if there is a difference in accuracy between two ways of patient data processing: impression/stone cast versus digital intraoral scanning (Aim 2). Reference 1. Nedwed V, Böhme A, Kossack K-H (2003) Eine praxistaugliche Methode zur indirekten Bracketplatzierung. Kieferorthop 17: 91-98
Brief summary in scientific language
The importance of placing brackets precisely cannot be overemphasized. Indirect bonding (IDB) offers more comfort for both, orthodontist and patient, and has been implemented years ago; however, it requires loads of laboratory work. Since recently a computer-designed transfer tray (Individua®) is on the market. This research was composed to compare bracket transfer accuracy of the innovative Individua® IDB trays with conventional ones made of silicone [1](Aim 1). We will also investigate if transfer accuracy is significantly different between CAD/CAM trays (Individua®) with two different ways of patient data processing: impression/stone cast versus digital intraoral scanning (Aim 2). Reference 1. Nedwed V, Böhme A, Kossack K-H (2003) Eine praxistaugliche Methode zur indirekten Bracketplatzierung. Kieferorthop 17: 91-98
Health condition or problem studied
- Free text:
- Bracket Transfer accuracy
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Transfer accuracy: transfer tray Individua® derived from intraoral scan
- Arm 2:
- Transfer accuracy: transfer tray Individua® derived from dental cast made from silicone-based impression
Endpoints
- Primary outcome:
- 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 outcome:
- Please see Primary Outcome
Study Design
- Purpose:
- Treatment
- Allocation:
- Non-randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Charité - Universitätsmedizin Berlin Berlin
Recruitment period and number of participants
- Planned study start date:
- 2016-08-15
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 24
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 12 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Charité - Universitätsmedizin Berlin, CharitéCentrum 03 für Zahn-, Mund- und KieferheilkundeProf. Dr. Paul-Georg Jost-BrinkmannAßmannshauser Str. 4-614197 BerlinGermany
- Telephone:
- +49 30 450 562 522
- Fax:
- +49 30 450 562 592
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kieferorthopaedie.charite.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Charité - Universitätsmedizin Berlin, CharitéCentrum 03 für Zahn-, Mund- und KieferheilkundeProf. Dr. Paul-Georg Jost-BrinkmannAßmannshauser Str. 4-614197 BerlinGermany
- Telephone:
- +49 30 450 562 522
- Fax:
- +49 30 450 562 952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kieferorthopaedie.charite.de
Contact for Public Queries
- Address:
- Charité - Universitätsmedizin Berlin, CharitéCentrum 03 für Zahn-, Mund- und KieferheilkundeProf. Dr. Paul-Georg Jost-BrinkmannAßmannshauser Str. 4-614197 BerlinGermany
- Telephone:
- +49 30 450 562 522
- Fax:
- +49 30 450 562 952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kieferorthopaedie.charite.de
Principal Investigator
- Address:
- Charité - Universitätsmedizin Berlin, CharitéCentrum 03 für Zahn-, Mund- und KieferheilkundeProf. Dr. Paul-Georg Jost-BrinkmannAßmannshauser Str. 4-614197 BerlinGermany
- Telephone:
- +49 30 450 562 522
- Fax:
- +49 30 450 562 952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://kieferorthopaedie.charite.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- DENTAURUM GmbH & Co. KGTurnstraße 3175228 IspringenGermany
- Telephone:
- +49 7231 803-0
- Fax:
- +49 7231 803-295
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- CA DIGITAL GmbHWillettstraße 1040822 MettmannGermany
- Telephone:
- +49 2104 8004100
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Charité – Universitätsmedizin BerlinCharitéplatz 110117 BerlinGermany
- Telephone:
- (+49)30-450517222
- Fax:
- (+49)30-450517952
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-03-22
- Ethics committee number:
- EA2/054/16
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-04-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry