NCT03647241

Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion

An Evaluation of the Efficacy of Self-Ligating Brackets Alone Or In Combination With Flapless Corticotomy In Leveling And Aligning Severely Crowded Dental Arches Compared With Conventional Brackets: A Randomized Clinical Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 17 Years – 28 Years
• Healthy volunteers: Not accepted

Summary

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched. 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

The sample of this study will be chosen according the following steps: * 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

• Malocclusion of Anterior Teeth

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
PROCEDURE	Corticotomy	Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.

Timeline

• Start date: 2018-08-15
• Primary completion: 2019-11-10
• Completion: 2020-06-19
• First posted: 2018-08-27
• Last updated: 2020-11-20

Locations

1 site across 1 country: Syria