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

Damascus University

Status: Completed

Conditions: Malocclusion of Anterior Teeth

Treatments: Procedure: Corticotomy; Device: Traditionally-Ligated Brackets; Device: Self-Ligating Brackets

Study type: Interventional

Funder types: Other

Identifiers

NCT03647241

UDDS-Ortho-10-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 17 to 28 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age of patients: 17-28 years.
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

1. Any systemic diseases that would affect tooth movement .
2. Any congenital syndromes or cleft lip and palate cases
3. Bad oral health

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Self-Ligating Brackets

Experimental group

Description:

Patients will be treated using self-ligating brackets to achieve proper alignment of teeth

Treatment:

Device: Self-Ligating Brackets

Self-Ligating Brackets with Corticotomy

Experimental group

Description:

Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment.

Treatment:

Device: Self-Ligating Brackets

Procedure: Corticotomy

Traditionally-Ligated Brackets

Active Comparator group

Description:

Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth

Treatment:

Device: Traditionally-Ligated Brackets