Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
This aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of Class I malocclusion patients treated on a nonextraction basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 19, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedApril 22, 2020
April 1, 2020
1.3 years
April 19, 2020
April 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Irregularity index (mm)
Crowding of anterior teeth changes after alignment
18 weeks
Distance between canine teeth (mm)
Measurement from right canine to left canine distance
18 weeks
Distance between first premolar teeth (mm)
Measurement from right first premolar to left first premolar distance
18 weeks
Distance between second premolar teeth (mm)
Measurement from right first premolar to left first premolar distance
18 weeks
Distance between first molar teeth (mm)
Measurement from right first molar to left first molar distance
18 weeks
Secondary Outcomes (1)
Arch length (mm)
18 weeks
Study Arms (2)
Lingual brackets
EXPERIMENTALPatients with moderate crowding without extraction treated with Incognito lingual bracket (3M Unitek, Bad Essen, Germany)
Labial brackets
EXPERIMENTALPatients with moderate crowding without extraction treated with labial bracket (3M Unitek, Ca, USA
Interventions
A type of bracket that applied lingual surface of teeth.
A type of bracket that applied labial surface of teeth.
Eligibility Criteria
You may qualify if:
- Class I malocclusion
- Completed permanent dentition
- Crowding ≥ 6 mm
You may not qualify if:
- Tooth loss or extraction except third molars
- Having cross bite
- Having genetic or hormonal disorder
- Using a chronic drug
- Previous orthodontic treatment and prosthetic restoration
- Inappropriate oral hygiene and periodontal diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Khattab TZ, Hajeer MY, Farah H, Al-Sabbagh R. Maxillary dental arch changes following the leveling and alignment stage with lingual and labial orthodontic appliances: a preliminary report of a randomized controlled trial. J Contemp Dent Pract. 2014 Sep 1;15(5):561-6. doi: 10.5005/jp-journals-10024-1579.
PMID: 25707826BACKGROUNDAuluck A. Lingual orthodontic treatment: what is the current evidence base? J Orthod. 2013 Sep;40 Suppl 1:S27-33. doi: 10.1179/1465313313Y.0000000073.
PMID: 24005948BACKGROUNDAlobeid A, El-Bialy T, Reimann S, Keilig L, Cornelius D, Jager A, Bourauel C. Comparison of the efficacy of tooth alignment among lingual and labial brackets: an in vitro study. Eur J Orthod. 2018 Nov 30;40(6):660-665. doi: 10.1093/ejo/cjy005.
PMID: 29546390BACKGROUNDZiebura T, Hohoff A, Flieger S, Stamm T. Accidental debondings: Buccal vs fully individualized lingual multibracket appliances. Am J Orthod Dentofacial Orthop. 2014 May;145(5):649-54. doi: 10.1016/j.ajodo.2013.12.030.
PMID: 24785929BACKGROUNDSifakakis I, Pandis N, Makou M, Eliades T, Katsaros C, Bourauel C. A comparative assessment of torque generated by lingual and conventional brackets. Eur J Orthod. 2013 Jun;35(3):375-80. doi: 10.1093/ejo/cjs029. Epub 2012 May 9.
PMID: 22573909BACKGROUNDSifakakis I, Pandis N, Makou M, Katsaros C, Eliades T, Bourauel C. A comparative assessment of forces and moments generated by lingual and conventional brackets. Eur J Orthod. 2013 Feb;35(1):82-6. doi: 10.1093/ejo/cjr048. Epub 2011 Apr 4.
PMID: 21464153BACKGROUNDFuck LM, Wiechmann D, Drescher D. Comparison of the initial orthodontic force systems produced by a new lingual bracket system and a straight-wire appliance. J Orofac Orthop. 2005 Sep;66(5):363-76. doi: 10.1007/s00056-005-0442-3. English, German.
PMID: 16231112BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yazgı Ay Ünüvar, PhD
Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 19, 2020
First Posted
April 22, 2020
Study Start
October 1, 2015
Primary Completion
January 5, 2017
Study Completion
April 1, 2017
Last Updated
April 22, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share