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

April 21, 2020 updated by: YAZGI AY UNUVAR, PhD, Aydin Adnan Menderes University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 22 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lingual brackets
Patients with moderate crowding without extraction treated with Incognito lingual bracket (3M Unitek, Bad Essen, Germany)
Device: Lingual brackets
A type of bracket that applied lingual surface of teeth.
Other Names:
  • Customized lingual brackets
Device: Labial brackets
A type of bracket that applied labial surface of teeth.
Other Names:
  • Conventional labial brackets
EXPERIMENTAL: Labial brackets
Patients with moderate crowding without extraction treated with labial bracket (3M Unitek, Ca, USA
Device: Lingual brackets
A type of bracket that applied lingual surface of teeth.
Other Names:
  • Customized lingual brackets
Device: Labial brackets
A type of bracket that applied labial surface of teeth.
Other Names:
  • Conventional labial brackets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irregularity index (mm)
Time Frame: 18 weeks
Crowding of anterior teeth changes after alignment
18 weeks
Distance between canine teeth (mm)
Time Frame: 18 weeks
Measurement from right canine to left canine distance
18 weeks
Distance between first premolar teeth (mm)
Time Frame: 18 weeks
Measurement from right first premolar to left first premolar distance
18 weeks
Distance between second premolar teeth (mm)
Time Frame: 18 weeks
Measurement from right first premolar to left first premolar distance
18 weeks
Distance between first molar teeth (mm)
Time Frame: 18 weeks
Measurement from right first molar to left first molar distance
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arch length (mm)
Time Frame: 18 weeks
Measurement of arch length from mesial side of right first molar to messiah side of left first molar
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Study Director: Yazgı Ay Ünüvar, PhD, Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

January 5, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (ACTUAL)

April 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHF-15010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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