NCT06401369

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 2, 2024

Last Update Submit

May 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

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

  • 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.

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

Study Arms (2)

The lingual fixed orthodontic group (LA)

EXPERIMENTAL

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

The labial fixed orthodontic group (BA)

ACTIVE COMPARATOR

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

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

The lingual fixed orthodontic group (LA)

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

The labial fixed orthodontic group (BA)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

Location

Related Publications (6)

  • 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.

    PMID: 23075062BACKGROUND
  • 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.

    PMID: 35371870BACKGROUND
  • 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.

    PMID: 28737425BACKGROUND
  • 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.

    PMID: 35606269BACKGROUND
  • 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.

    PMID: 37290351BACKGROUND
  • 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.

    PMID: 35600066BACKGROUND

Study Officials

  • Jehad M. Kara-Boulad, DDS MSc PhD

    Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

    PRINCIPAL INVESTIGATOR
  • Ahmad S. Burhan, DDS MSc PhD

    Department of Orthodontics, Faculty of Dentistry, Damascus University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 6, 2024

Study Start

March 10, 2022

Primary Completion

June 15, 2022

Study Completion

September 15, 2023

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations