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CompletedNCT06401369Updated May 6, 2024

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

An interventional study of Lingual brackets and Buccal brackets in Crowding of Anterior Maxillary Teeth and Crowding of Anterior Mandibular Teeth, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Mar 2022, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Crowding of Anterior Maxillary Teeth
  • Crowding of Anterior Mandibular Teeth

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03

In context

Crowding

88 studies on the registry are indexed under Crowding; 22 are open to participants now.

This study's enrollment of 40 is above the median of 36 across 74 interventional studies indexed under Crowding.

Browse Crowding studies →

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureLingual brackets

    These brackets will be used on the lingual surfaces of the upper and lower teeth.

  • ProcedureBuccal brackets

    These brackets will be used on the vestibular surfaces of the upper and lower teeth.

06

What researchers measure

Primary outcomes

  1. Change in tooth lengths

    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).

    Time frame: T0: one day before the commencement of treatment. T1: one day following the end of treatment

  2. Change in the alveolar bone height

    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.

    Time frame: T0: one day before the commencement of treatment. T1: one day following the end of treatment

07

Study locations

1 site
  • Department of Orthodontics, Faculty of Dentistry, University of Damsacus
    Damascus, DM20 HAJ72, Syrian Arab Republic
08

References and documents

Publications

  • Khattab TZ, Farah H, Al-Sabbagh R, Hajeer MY, Haj-Hamed Y. Speech performance and oral impairments with lingual and labial orthodontic appliances in the first stage of fixed treatment. Angle Orthod. 2013 May;83(3):519-26. doi: 10.2319/073112-619.1. Epub 2012 Oct 18. PubMed 23075062 ↗
  • Kara-Boulad JM, Burhan AS, Hajeer MY, Khattab TZ, Nawaya FR. Evaluation of the Oral Health-Related Quality of Life (OHRQoL) in Patients Undergoing Lingual Versus Labial Fixed Orthodontic Appliances: A Randomized Controlled Clinical Trial. Cureus. 2022 Mar 22;14(3):e23379. doi: 10.7759/cureus.23379. eCollection 2022 Mar. PubMed 35371870 ↗
  • Nassif CE, Cotrim-Ferreira A, Conti ACCF, Valarelli DP, de Almeida Cardoso M, de Almeida-Pedrin RR. Comparative study of root resorption of maxillary incisors in patients treated with lingual and buccal orthodontics. Angle Orthod. 2017 Nov;87(6):795-800. doi: 10.2319/041117-247.1. Epub 2017 Jul 24. PubMed 28737425 ↗
  • Hajeer MY, Al-Homsi HK, Alfailany DT, Murad RMT. Evaluation of the diagnostic accuracy of CBCT-based interpretations of maxillary impacted canines compared to those of conventional radiography: An in vitro study. Int Orthod. 2022 Jun;20(2):100639. doi: 10.1016/j.ortho.2022.100639. Epub 2022 May 21. PubMed 35606269 ↗
  • Alfailany DT, Shaweesh AI, Hajeer MY, Brad B, Alhaffar JB. The diagnostic accuracy of cone-beam computed tomography and two-dimensional imaging methods in the 3D localization and assessment of maxillary impacted canines compared to the gold standard in-vivo readings: A cross-sectional study. Int Orthod. 2023 Sep;21(3):100780. doi: 10.1016/j.ortho.2023.100780. Epub 2023 Jun 6. PubMed 37290351 ↗
  • Kara-Boulad JM, Burhan AS, Hajeer MY, Khattab TZ, Nawaya FR, Al-Sabbagh R. Treatment of Moderately Crowded Teeth Using Lingual Fixed Appliance Prepared by a Modified HIRO(R) Technique: A Case Report and Method Description. Cureus. 2022 May 17;14(5):e25077. doi: 10.7759/cureus.25077. eCollection 2022 May. PubMed 35600066 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06401369
Responsible party
Sponsor
First posted
May 6, 2024
Start date
Mar 10, 2022
Primary completion
Jun 15, 2022
Completion
Sep 15, 2023
Last update
May 6, 2024

Study contacts

Jehad M. Kara-Boulad, DDS MSc PhD
principal investigator · Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Ahmad S. Burhan, DDS MSc PhD
study director · Department of Orthodontics, Faculty of Dentistry, Damascus University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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