Comparison Between Lingual and Labial Fixed Orthodontic Appliances in the Treatment of Crowding Cases
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
1 other identifier
interventional
44
1 country
1
Brief 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.
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 Feb 2018
Longer than P75 for not_applicable
1 active site
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
February 22, 2018
CompletedFirst Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2021
CompletedFebruary 14, 2022
February 1, 2022
3.5 years
December 17, 2018
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
ABO- Objective Grading System
After treatment completion, an average of 1 year
Change in oral health related quality of life
(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.
Study Arms (2)
Lingual appliances "AO®"
EXPERIMENTALPatients with moderate crowding will be treated without extraction using lingual fixed appliances from American Orthodontics company.
Labial appliances "AO®"
EXPERIMENTALPatients with moderate crowding will be treated without extraction using labial fixed appliances from American Orthodontics company.
Interventions
Patients with moderate crowding will be treated without extraction using lingual appliances.
Patients with moderate crowding will be treated without extraction using labial appliances.
Eligibility Criteria
You may qualify if:
- Class I malocclusion.
- Moderate crowding in the dental arch (3 to 5-mm tooth-size arch-length discrepancy).
You may not qualify if:
- Inappropriate oral hygiene and periodontal diseases.
- Previous orthodontic treatment.
- Craniofacial syndromes, cleft lip and/or palate (soft and/or hard).
- Subject with systemic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Damascus University
Damascus, 00963, Syria
Related 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. doi: 10.1007/s00056-002-0124-3. English, German.
PMID: 12132310BACKGROUNDJacobs 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.
PMID: 24456620BACKGROUNDKhattab 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: 23075062BACKGROUNDKlang 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.
PMID: 30249268BACKGROUNDPauls 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.
PMID: 20963544BACKGROUNDPauwels 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.
PMID: 25805884BACKGROUNDTian 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.
PMID: 26445719BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmad S Burhan, PhD.
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
December 17, 2018
First Posted
February 22, 2019
Study Start
February 22, 2018
Primary Completion
August 22, 2021
Study Completion
December 15, 2021
Last Updated
February 14, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share
The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University