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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04357067
Other study ID # DHF-15010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2015
Est. completion date April 1, 2017

Study information

Verified date April 2020
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 1, 2017
Est. primary completion date January 5, 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 22 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Lingual brackets
A type of bracket that applied lingual surface of teeth.
Labial brackets
A type of bracket that applied labial surface of teeth.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

References & Publications (7)

Alobeid A, El-Bialy T, Reimann S, Keilig L, Cornelius D, Jäger 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. — View Citation

Auluck A. Lingual orthodontic treatment: what is the current evidence base? J Orthod. 2013 Sep;40 Suppl 1:S27-33. doi: 10.1179/ortho/40.s1.s27. Review. — View 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. English, German. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Irregularity index (mm) Crowding of anterior teeth changes after alignment 18 weeks
Primary Distance between canine teeth (mm) Measurement from right canine to left canine distance 18 weeks
Primary Distance between first premolar teeth (mm) Measurement from right first premolar to left first premolar distance 18 weeks
Primary Distance between second premolar teeth (mm) Measurement from right first premolar to left first premolar distance 18 weeks
Primary Distance between first molar teeth (mm) Measurement from right first molar to left first molar distance 18 weeks
Secondary Arch length (mm) Measurement of arch length from mesial side of right first molar to messiah side of left first molar 18 weeks