Clinical trial NCT06401369: Comparing Labial and Lingual Orthodontic Appliances on Root Resorption and Bone Height
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crowding of Anterior Maxillary Teeth
Crowding of Anterior Mandibular Teeth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Change in tooth lengths
timeFrame: T0: one day before the commencement of treatment. T1: one day following the end of treatment
measure: Change in the alveolar bone height
timeFrame: T0: one day before the commencement of treatment. T1: one day following the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Jehad M. Kara-Boulad, DDS MSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University
name: Ahmad S. Burhan, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.