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Completed

NCT Number: NCT03850951

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

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.

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Key information

Conditions

Crowding Behavior Spatial Behavior

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00963, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lingual appliances

Device

Patients with moderate crowding will be treated without extraction using lingual appliances.

Labial appliances

Device

Patients with moderate crowding will be treated without extraction using labial appliances.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2019
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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