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CompletedNCT03850951Updated Feb 14, 2022

Comparison Between Lingual and Labial Fixed Orthodontic Appliances in the Treatment of Crowding Cases

An interventional study of Lingual appliances and Labial appliances in Crowding, 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 2022-02-14.

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

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Feb 2018, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study summary

Patients who have moderate crowding that could be treated without extraction will be treated in this study using either lingual or labial fixed orthodontic appliances. All patients will receive a cone-beam computed tomography (CBCT) scan in two different times (T0: before treatment, T1: after treatment). The dentoalveolar changes will be assessed.

Read the detailed description

Lingual orthodontic appliances provide an ultimate esthetic solution for patients who do not want visible orthodontic appliances. Recently, lingual orthodontic treatment outcomes have become similar and comparable to those produced with labial orthodontic treatment. However, placement of orthodontic brackets on the lingual surfaces of teeth causes changes in their morphology, which results in articulation problems, chewing difficulties, tongue irritation and other impairments. In this respect, the main difference between the labial and lingual techniques is the distance between the point of application of the force that is transmitted through the bracket and the centre of resistance of the tooth. Consequently, the displacement and stress induced in bone by these two techniques will also differ, and these need to be evaluated so that useful comparisons can be made between these two techniques. Patients who have moderate crowding that could be treated without extraction will be treated in this study using either lingual or labial fixed orthodontic appliances. All patients will receive a cone-beam computed tomography (CBCT) scan in two different times (T0: before treatment, T1: after treatment). The dentoalveolar changes will be assessed.

02

Conditions studied

  • Crowding

Keywords

  • Fixed appliances
  • labial appliances
  • lingual appliances
03

In context

Lead sponsor

Damascus University is the lead sponsor of 206 studies on the registry; 10 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

Inclusion criteria

  • Class I malocclusion.
  • Moderate crowding in the dental arch (3 to 5-mm tooth-size arch-length discrepancy).

Exclusion criteria

Exclusion Criteria:

  • Inappropriate oral hygiene and periodontal diseases.
  • Previous orthodontic treatment.
  • Craniofacial syndromes, cleft lip and/or palate (soft and/or hard).
  • Subject with systemic diseases.
05

Study design

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

Study arms

  • Experimental
    Lingual appliances "AO®"

    Patients with moderate crowding will be treated without extraction using lingual fixed appliances from American Orthodontics company.

    Device: Lingual appliances

  • Experimental
    Labial appliances "AO®"

    Patients with moderate crowding will be treated without extraction using labial fixed appliances from American Orthodontics company.

    Device: Labial appliances

Interventions

  • DeviceLingual appliances

    Patients with moderate crowding will be treated without extraction using lingual appliances.

  • DeviceLabial appliances

    Patients with moderate crowding will be treated without extraction using labial appliances.

06

What researchers measure

Primary outcomes

  1. Dentoalveolar changes after crowding treatment

    Dentoalveolar changes before and after crowding treatment will be evaluated using CBCT.

    Time frame: Changes will be evaluated before and after crowding treatment which will take approximately 12 months

Secondary outcomes

  1. ABO- Objective Grading System

    Objective grading system phase III examination will be done to systematically grade post treatment records. The ABO-OGS contains eight criteria: alignment, marginal ridges, buccolingual inclination, occlusal relationships, occlusal contacts, overjet, interproximal contacts and root angulation. Patients will be deducted for any discrepancy from ideal as described by the ABO. Every case that loses 30 or fewer points generally receives a passing grade for the ABO phase III examination.

    Time frame: After treatment completion, an average of 1 year

  2. Change in oral health related quality of life

    Patients in both groups will be given a questionnaire to be filled. The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled in 3 minutes. OHIP-14 includes a subjective evaluation of the individual's oral health, functional well being, emotional well being, expectations and satisfaction with care and sense of self.

    Time frame: (1) at the beginning of the treatment, (2) after week, (3) after 2 weeks, (4) after 4 weeks, (5) after 6 months, (6) after treatment completion, an average of 1 year.

07

Study locations

1 site
  • Damascus University
    Damascus, 00963, Syrian Arab Republic
08

References and documents

Publications

  • Fritz U, Diedrich P, Wiechmann D. Lingual technique--patients' characteristics, motivation and acceptance. Interpretation of a retrospective survey. J Orofac Orthop. 2002 May;63(3):227-33. doi: 10.1007/s00056-002-0124-3. English, German. PubMed 12132310 ↗
  • Jacobs C, Gebhardt PF, Jacobs V, Hechtner M, Meila D, Wehrbein H. Root resorption, treatment time and extraction rate during orthodontic treatment with self-ligating and conventional brackets. Head Face Med. 2014 Jan 23;10:2. doi: 10.1186/1746-160X-10-2. PubMed 24456620 ↗
  • 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 ↗
  • Klang E, Beyling F, Knosel M, Wiechmann D. Quality of occlusal outcome following space closure in cases of lower second premolar aplasia using lingual orthodontic molar mesialization without maxillary counterbalancing extraction. Head Face Med. 2018 Sep 24;14(1):17. doi: 10.1186/s13005-018-0176-2. PubMed 30249268 ↗
  • Pauls AH. Therapeutic accuracy of individualized brackets in lingual orthodontics. J Orofac Orthop. 2010 Sep;71(5):348-61. doi: 10.1007/s00056-010-1027-3. Epub 2010 Oct 21. English, German. PubMed 20963544 ↗
  • Pauwels R. Cone beam CT for dental and maxillofacial imaging: dose matters. Radiat Prot Dosimetry. 2015 Jul;165(1-4):156-61. doi: 10.1093/rpd/ncv057. Epub 2015 Mar 23. PubMed 25805884 ↗
  • Tian YL, Liu F, Sun HJ, Lv P, Cao YM, Yu M, Yue Y. Alveolar bone thickness around maxillary central incisors of different inclination assessed with cone-beam computed tomography. Korean J Orthod. 2015 Sep;45(5):245-52. doi: 10.4041/kjod.2015.45.5.245. Epub 2015 Sep 23. PubMed 26445719 ↗

Individual participant data

Plan to share: No — The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03850951
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
Feb 22, 2019
Start date
Feb 22, 2018
Primary completion
Aug 22, 2021
Completion
Dec 15, 2021
Last update
Feb 14, 2022

Study contacts

Ahmad S Burhan, PhD.
study director · 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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