Comparing Labial and Lingual Orthodontic Appliances on Root Resorption and Bone Height

May 2, 2024 updated by: Damascus University

CBCT-based Assessment of Apical Root Resorption and Alveolar Bone Height Following Orthodontic Treatment of Moderate Crowding With Labial vs. Lingual Fixed Appliances: A Randomized Controlled Trial

Patients who have moderate crowding that could be treated on a non-extraction will be treated in this study. The apical root resorption and alveolar bone height of the lingual and labial fixed appliances will be assessed. All patients will receive a cone-beam computed tomography (CBCT) scan at two different times (T0: Before treatment, T1: After treatment).

There are two groups: The first group (Experimental): The patients in this group will be treated using Lingual Fixed Orthodontic Appliances. The second group (Control): The patients in this group will be treated using Labial Fixed Orthodontic Appliances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, the therapeutic results of lingual orthodontics have become similar to those produced by labial orthodontics. However, lingual appliances act differently. The application of force near the center of resistance and the distance between the lingual brackets leads to an increase in friction and, thus, an increase in the force applied during treatment. In addition, the contact of the lower incisors with the brackets of the upper incisors in the lingual technique can lead to the intrusion of these incisors. Therefore, these factors can be potential risks for apical root resorption and alveolar bone height in lingual orthodontics.

2D radiographs may not accurately depict the true amount of root resorption due to magnification errors and difficulties in obtaining repeatable images. Besides, conventional two-dimensional radiographs cannot accurately assess alveolar bone height in the anterior region. CBCT has proven to be valuable in diagnosing root resorption due to its capability to produce distortion-free images, as well as its ability to maintain a high level of reproducibility despite changes in tooth positions after treatment, with high sensitivity and specificity. On the other hand, the use of CBCT allows for an evaluation of alveolar bone height in the anterior region with high accuracy and precision.

Study Type

Interventional

Enrollment (Actual)

40

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

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20 HAJ72
        • Department of Orthodontics, Faculty of Dentistry, University of Damsacus

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Class I molar and canine relationships on both sides.
  2. Moderate crowding of both arches of about 4 to 6 mm treated on a non-extraction basis.
  3. Age from 18 to 25 years.
  4. The presence of permanent dentition (except third molars).

Exclusion Criteria:

  1. The existence of craniofacial syndromes, cleft lip and/or palate (soft and/or hard).
  2. Skeletal or dental crossbite.
  3. Patients with missing teeth or periodontal diseases.
  4. Previous orthodontic treatment.

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: The lingual fixed orthodontic group (LA)
This group received treatment with lingual brackets with 0.018-inch slots (DTC Orthodontics, Hangzhou, China) applied with the aid of a special, indirect bonding technique, the "Modified HIRO® Technique." Individual lingual archwires (Forestadent®, Germany) were also used.
Procedure: Lingual brackets
These brackets will be used on the lingual surfaces of the upper and lower teeth.
Active Comparator: The labial fixed orthodontic group (BA)
Patients in this group received treatment with labial appliances with 0.018-inch slots (American Orthodontics brackets, Mini Master series, MBT prescription) directly bonded on both arches. Prefabricated archwires (American Orthodontics, Sheboygan, WI, USA) were also used.
Procedure: Buccal brackets
These brackets will be used on the vestibular surfaces of the upper and lower teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tooth lengths
Time Frame: T0: one day before the commencement of treatment. T1: one day following the end of treatment

Axial, coronal, and sagittal planes of the CBCT images will be reoriented to be perpendicular to the long axis of each tooth under assessment. The distances were measured as follows.

Central and lateral incisors: from incisal edge to apex (sagittal section). Canines: from cusp tip to apex (sagittal section). Single-rooted premolar: from vestibular cusp tip to apex (sagittal section). Two-rooted premolar: from vestibular cusp tip to apex (sagittal section) and lingual cusp tip to apex (coronal section).

Upper molars: from the mesiolingual cusp tip to the apex of the lingual root of the molar (coronal section), from the mesobuccal cusp tip to the apex of the mesobuccal root of the molar (sagittal section), from distobuccal cusp tip to the apex of distobuccal root of molar (sagittal section).
T0: one day before the commencement of treatment. T1: one day following the end of treatment
Change in the alveolar bone height
Time Frame: T0: one day before the commencement of treatment. T1: one day following the end of treatment

The CBCT images were redirected according to the long axis of each tooth as given previously.

The distance between the cementoenamel junction and the crest of the alveolar bone was measured in the sagittal plane for central and lateral incisors, while in the coronal plane for canines. For the premolars and first molars, the distance between the cementoenamel junction and the crest of the alveolar bone was measured in the coronal plane.
T0: one day before the commencement of treatment. T1: one day following the end of treatment

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Jehad M. Kara-Boulad, DDS MSc PhD, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
  • Study Director: Ahmad S. Burhan, DDS MSc PhD, Department of Orthodontics, 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)

March 10, 2022

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-1-2024

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

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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