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

Crowding Clinical Trial

Official title:

Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Fixed Lingual Orthodontic Appliances Versus Fixed Labial Orthodontic Appliances. 'A Clinical Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850951
• Other study ID #: UDDS-Ortho-04-2018
• Status: Completed
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 15, 2021
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Class I malocclusion.

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

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.

Related Conditions & MeSH terms

• Crowding

Intervention

Device:
• Lingual appliances
Patients with moderate crowding will be treated without extraction using lingual appliances.
• Labial appliances
Patients with moderate crowding will be treated without extraction using labial appliances.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

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. English, German. — View Citation

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. — View 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. — View Citation

Klang E, Beyling F, Knösel 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dentoalveolar changes after crowding treatment	Dentoalveolar changes before and after crowding treatment will be evaluated using CBCT.	Changes will be evaluated before and after crowding treatment which will take approximately 12 months
Secondary	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.	After treatment completion, an average of 1 year
Secondary	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.	(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.