Clinical trial NCT03647241: Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion of Anterior Teeth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Alignment
timeFrame: This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months)
measure: Change in Little's Index
timeFrame: T0: one day before the beginning of treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months)
measure: Change in inter-canine width lingually
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
measure: Change in inter-canine width
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
measure: Change in Canine Rotation Angle
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
measure: Change in Lateral Incisor Rotation Angle
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
measure: Change in Central Incisor Rotation Angle
timeFrame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
name: Heba Al-Ibrahim, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_CHAIR
affiliation: Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA
name: Issam Khoury, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.