Comparison Between Lingual and Labial Fixed Orthodontic Appliances in the Treatment of Crowding Cases

February 10, 2022 updated by: Damascus University

Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Fixed Lingual Orthodontic Appliances Versus Fixed Labial Orthodontic Appliances. 'A Clinical Randomized Controlled Trial

Patients who have moderate crowding that could be treated without extraction will be treated in this study using either lingual or labial fixed orthodontic appliances. All patients will receive a cone-beam computed tomography (CBCT) scan in two different times (T0: before treatment, T1: after treatment). The dentoalveolar changes will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lingual orthodontic appliances provide an ultimate esthetic solution for patients who do not want visible orthodontic appliances. Recently, lingual orthodontic treatment outcomes have become similar and comparable to those produced with labial orthodontic treatment. However, placement of orthodontic brackets on the lingual surfaces of teeth causes changes in their morphology, which results in articulation problems, chewing difficulties, tongue irritation and other impairments. In this respect, the main difference between the labial and lingual techniques is the distance between the point of application of the force that is transmitted through the bracket and the centre of resistance of the tooth. Consequently, the displacement and stress induced in bone by these two techniques will also differ, and these need to be evaluated so that useful comparisons can be made between these two techniques. Patients who have moderate crowding that could be treated without extraction will be treated in this study using either lingual or labial fixed orthodontic appliances. All patients will receive a cone-beam computed tomography (CBCT) scan in two different times (T0: before treatment, T1: after treatment). The dentoalveolar changes will be assessed.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Class I malocclusion.
  • Moderate crowding in the dental arch (3 to 5-mm tooth-size arch-length discrepancy).

Exclusion Criteria:

  • Inappropriate oral hygiene and periodontal diseases.
  • Previous orthodontic treatment.
  • Craniofacial syndromes, cleft lip and/or palate (soft and/or hard).
  • Subject with systemic 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lingual appliances "AO®"
Patients with moderate crowding will be treated without extraction using lingual fixed appliances from American Orthodontics company.
Device: Lingual appliances
Patients with moderate crowding will be treated without extraction using lingual appliances.
Experimental: Labial appliances "AO®"
Patients with moderate crowding will be treated without extraction using labial fixed appliances from American Orthodontics company.
Device: Labial appliances
Patients with moderate crowding will be treated without extraction using labial appliances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentoalveolar changes after crowding treatment
Time Frame: Changes will be evaluated before and after crowding treatment which will take approximately 12 months
Dentoalveolar changes before and after crowding treatment will be evaluated using CBCT.
Changes will be evaluated before and after crowding treatment which will take approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABO- Objective Grading System
Time Frame: After treatment completion, an average of 1 year
Objective grading system phase III examination will be done to systematically grade post treatment records. The ABO-OGS contains eight criteria: alignment, marginal ridges, buccolingual inclination, occlusal relationships, occlusal contacts, overjet, interproximal contacts and root angulation. Patients will be deducted for any discrepancy from ideal as described by the ABO. Every case that loses 30 or fewer points generally receives a passing grade for the ABO phase III examination.
After treatment completion, an average of 1 year
Change in oral health related quality of life
Time Frame: (1) at the beginning of the treatment, (2) after week, (3) after 2 weeks, (4) after 4 weeks, (5) after 6 months, (6) after treatment completion, an average of 1 year.
Patients in both groups will be given a questionnaire to be filled. The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled in 3 minutes. OHIP-14 includes a subjective evaluation of the individual's oral health, functional well being, emotional well being, expectations and satisfaction with care and sense of self.
(1) at the beginning of the treatment, (2) after week, (3) after 2 weeks, (4) after 4 weeks, (5) after 6 months, (6) after treatment completion, an average of 1 year.

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Study Director: Ahmad S Burhan, PhD., Faculty of Dentistry, Damascus University

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)

February 22, 2018

Primary Completion (Actual)

August 22, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UDDS-Ortho-04-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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