NCT03850951

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

3.5 years

First QC Date

December 17, 2018

Last Update Submit

February 10, 2022

Conditions

Keywords

Fixed applianceslabial applianceslingual appliances

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®"

EXPERIMENTAL

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

Device: Lingual appliances

Labial appliances "AO®"

EXPERIMENTAL

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

Device: Labial appliances

Interventions

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

Lingual appliances "AO®"

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

Labial appliances "AO®"

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 12132310BACKGROUND
  • 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.

    PMID: 24456620BACKGROUND
  • 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: 23075062BACKGROUND
  • 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.

    PMID: 30249268BACKGROUND
  • 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.

    PMID: 20963544BACKGROUND
  • 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.

    PMID: 25805884BACKGROUND
  • 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.

    PMID: 26445719BACKGROUND

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Officials

  • Ahmad S Burhan, PhD.

    Faculty of Dentistry, Damascus University

    STUDY DIRECTOR

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

Locations