Clinical trial NCT04357067: Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase
Official title: Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irregular Teeth
Keywords: Customized lingual brackets
lingual orthodontics
digital model
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study included 20 patients who presented with Class I malocclusion and scheduled for orthodontic treatment without tooth extraction. The patients were randomly assigned for treatment with customized lingual brackets or with conventional labial brackets. During the alignment period 0.012 inch (T1) , 0.014 inch(T2), 0.016 inch (T3)NiTi arch wires were performed respectively and the control visits were scheduled by 6-weeks intervals. In all sessions, digital models were obtained by intra-oral scanning device after removal of arch wire, which then analyzed by software. In order to analyze change in T0 (pretreatment), T1, T2 and T3; Little's irregularity index, distance between canine teeth, distance between first premolar teeth, distance between second premolar teeth, distance between first molar teeth and arch length measurements were performed on digital models.

Eligibility criteria: Inclusion Criteria:

* Class I malocclusion
* Completed permanent dentition
* Crowding ≥ 6 mm

Exclusion Criteria:

* 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

Primary outcomes:
measure: Irregularity index (mm)
timeFrame: 18 weeks
measure: Distance between canine teeth (mm)
timeFrame: 18 weeks
measure: Distance between first premolar teeth (mm)
timeFrame: 18 weeks
measure: Distance between second premolar teeth (mm)
timeFrame: 18 weeks
measure: Distance between first molar teeth (mm)
timeFrame: 18 weeks
Secondary outcomes:
measure: Arch length (mm)
timeFrame: 18 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics
name: Yazgı Ay Ünüvar, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Auluck A. Lingual orthodontic treatment: what is the current evidence base? J Orthod. 2013 Sep;40 Suppl 1:S27-33. doi: 10.1179/1465313313Y.0000000073.
citation: Alobeid 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.
citation: Ziebura 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.
citation: Sifakakis 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.
citation: Sifakakis 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.
citation: Fuck 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.