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

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT03850951
Collaborator
(none)
44
1
2
45.7
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Lingual appliances
  • Device: Labial appliances
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 22, 2018
Actual Primary Completion Date :
Aug 22, 2021
Actual Study Completion Date :
Dec 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Dentoalveolar changes after crowding treatment [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.

Secondary Outcome Measures

  1. ABO- Objective Grading System [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.

  2. Change in oral health related quality of life [(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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damascus University Damascus Syrian Arab Republic 00963

Sponsors and Collaborators

  • Damascus University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT03850951
Other Study ID Numbers:
  • UDDS-Ortho-04-2018
First Posted:
Feb 22, 2019
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damascus University

Study Results

No Results Posted as of Feb 14, 2022