Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion
NCT ID: NCT03647241
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2018-08-15
2020-06-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth:
* Group 1 : Patients will be treated using self-ligating brackets
* Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy.
* Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth)
At the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) Also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial.
* A random sample of 100 patients from the sampling frame will be chosen.
* An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate.
* A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Self-Ligating Brackets
Patients will be treated using self-ligating brackets to achieve proper alignment of teeth
Self-Ligating Brackets
These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
Self-Ligating Brackets with Corticotomy
Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment.
Self-Ligating Brackets
These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
Corticotomy
Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.
Traditionally-Ligated Brackets
Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth
Traditionally-Ligated Brackets
These brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Self-Ligating Brackets
These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
Traditionally-Ligated Brackets
These brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.
Corticotomy
Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
3. The Little's Index of Irregularity is over 7 mm.
4. There is no previous orthodontic treatment.
5. The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
6. The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).
7. Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
8. Overbite is between 0-4 mm.
9. There is no skeletal constriction on the upper jaw.
10. Full presence of all permanent teeth in the dental arch (except for third molars)
Exclusion Criteria
2. Any congenital syndromes or cleft lip and palate cases
3. Bad oral health
17 Years
28 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Damascus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heba Al-Ibrahim, DDS
Role: PRINCIPAL_INVESTIGATOR
MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Mohammad Y Hajeer, DDS MSc PhD
Role: STUDY_CHAIR
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Issam Khoury, DDS MSc PhD
Role: STUDY_DIRECTOR
Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Orthodontics, University of Damascus Dental School
Damascus, , Syria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yang X, Xue C, He Y, Zhao M, Luo M, Wang P, Bai D. Transversal changes, space closure, and efficiency of conventional and self-ligating appliances : A quantitative systematic review. J Orofac Orthop. 2018 Jan;79(1):1-10. doi: 10.1007/s00056-017-0110-4. Epub 2017 Nov 3.
Yang X, Su N, Shi Z, Xiang Z, He Y, Han X, Bai D. Effects of self-ligating brackets on oral hygiene and discomfort: a systematic review and meta-analysis of randomized controlled clinical trials. Int J Dent Hyg. 2017 Feb;15(1):16-22. doi: 10.1111/idh.12220. Epub 2016 Apr 20.
Yang X, He Y, Chen T, Zhao M, Yan Y, Wang H, Bai D. Differences between active and passive self-ligating brackets for orthodontic treatment : Systematic review and meta-analysis based on randomized clinical trials. J Orofac Orthop. 2017 Mar;78(2):121-128. doi: 10.1007/s00056-016-0059-8. Epub 2017 Feb 21.
Qamruddin I, Alam MK, Mahroof V, Fida M, Khamis MF, Husein A. Effects of low-level laser irradiation on the rate of orthodontic tooth movement and associated pain with self-ligating brackets. Am J Orthod Dentofacial Orthop. 2017 Nov;152(5):622-630. doi: 10.1016/j.ajodo.2017.03.023.
Nahas AZ, Samara SA, Rastegar-Lari TA. Decrowding of lower anterior segment with and without photobiomodulation: a single center, randomized clinical trial. Lasers Med Sci. 2017 Jan;32(1):129-135. doi: 10.1007/s10103-016-2094-5. Epub 2016 Oct 20.
Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
Wahab RM, Idris H, Yacob H, Ariffin SH. Comparison of self- and conventional-ligating brackets in the alignment stage. Eur J Orthod. 2012 Apr;34(2):176-81. doi: 10.1093/ejo/cjq179. Epub 2011 Apr 8.
Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):470.e1-8. doi: 10.1016/j.ajodo.2008.04.018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UDDS-Ortho-10-2018
Identifier Type: -
Identifier Source: org_study_id