Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase

NCT ID: NCT04357067

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irregular Teeth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lingual brackets

Patients with moderate crowding without extraction treated with Incognito lingual bracket (3M Unitek, Bad Essen, Germany)

Group Type EXPERIMENTAL

Lingual brackets

Intervention Type DEVICE

A type of bracket that applied lingual surface of teeth.

Labial brackets

Intervention Type DEVICE

A type of bracket that applied labial surface of teeth.

Labial brackets

Patients with moderate crowding without extraction treated with labial bracket (3M Unitek, Ca, USA

Group Type EXPERIMENTAL

Lingual brackets

Intervention Type DEVICE

A type of bracket that applied lingual surface of teeth.

Labial brackets

Intervention Type DEVICE

A type of bracket that applied labial surface of teeth.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lingual brackets

A type of bracket that applied lingual surface of teeth.

Intervention Type DEVICE

Labial brackets

A type of bracket that applied labial surface of teeth.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Customized lingual brackets Conventional labial brackets

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

YAZGI AY UNUVAR, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yazgı Ay Ünüvar, PhD

Role: STUDY_DIRECTOR

Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25707826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24005948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29546390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24785929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22573909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21464153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16231112 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DHF-15010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.