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OpenTrials
Completed

NCT Number: NCT04357067

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

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.

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Key information

Conditions

Irregular Teeth Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

15 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lingual brackets

Device

A type of bracket that applied lingual surface of teeth.

Other names: Customized lingual brackets

Labial brackets

Device

A type of bracket that applied labial surface of teeth.

Other names: Conventional labial brackets

Primary outcomes

  1. Irregularity index (mm)

    Time frame: 18 weeks

    Crowding of anterior teeth changes after alignment

  2. Distance between canine teeth (mm)

    Time frame: 18 weeks

    Measurement from right canine to left canine distance

  3. Distance between first premolar teeth (mm)

    Time frame: 18 weeks

    Measurement from right first premolar to left first premolar distance

  4. Distance between second premolar teeth (mm)

    Time frame: 18 weeks

    Measurement from right first premolar to left first premolar distance

  5. Distance between first molar teeth (mm)

    Time frame: 18 weeks

    Measurement from right first molar to left first molar distance

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2020
Registry last updated
Apr 22, 2020

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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