Comparing Labial and Lingual Orthodontic Appliances on Root Resorption and Bone Height
CBCT-based Assessment of Apical Root Resorption and Alveolar Bone Height Following Orthodontic Treatment of Moderate Crowding With Labial vs. Lingual Fixed Appliances: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedFirst Submitted
Initial submission to the registry
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 6, 2024
CompletedMay 6, 2024
May 1, 2024
3 months
May 2, 2024
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)
EXPERIMENTALThis 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.
The labial fixed orthodontic group (BA)
ACTIVE COMPARATORPatients 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.
Interventions
These brackets will be used on the lingual surfaces of the upper and lower teeth.
These brackets will be used on the vestibular surfaces of the upper and lower teeth.
Eligibility Criteria
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
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: 23075062BACKGROUNDKara-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: 35371870BACKGROUNDNassif 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: 28737425BACKGROUNDHajeer 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: 35606269BACKGROUNDAlfailany 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: 37290351BACKGROUNDKara-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
- PRINCIPAL INVESTIGATOR
Jehad M. Kara-Boulad, DDS MSc PhD
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
- STUDY DIRECTOR
Ahmad S. Burhan, DDS MSc PhD
Department of Orthodontics, Faculty of Dentistry, Damascus University
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