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

NCT03647241 | Completed DMC

• 1 other identifier: UDDS-Ortho-10-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion of Anterior Teeth

Outcome Measures

Primary Outcomes (7)

• Duration of Alignment

  The time required in days will be calculated from the beginning of treatment till the end of the alignment stage

  This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months)

• Change in Little's Index

  The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is.

  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)

• Change in inter-canine width lingually

  The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models.

  T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)

• Change in inter-canine width

  The distance between the cusp tips of the upper canines. This variable will be measured on plaster models.

  T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)

• Change in Canine Rotation Angle

  It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine.

  T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)

• Change in Lateral Incisor Rotation Angle

  It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor.

  T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)

• Change in Central Incisor Rotation Angle

  It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor.

  T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)

Study Arms (3)

Self-Ligating Brackets

EXPERIMENTAL

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

Device: Self-Ligating Brackets

Self-Ligating Brackets with Corticotomy

EXPERIMENTAL

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

Device: Self-Ligating Brackets; Procedure: Corticotomy

Traditionally-Ligated Brackets

ACTIVE COMPARATOR

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

Device: Traditionally-Ligated Brackets

Interventions

Self-Ligating Brackets DEVICE

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.

Also known as: SLBs

Self-Ligating Brackets; Self-Ligating Brackets with Corticotomy

Traditionally-Ligated Brackets DEVICE

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.

Also known as: Non-SLBs

Traditionally-Ligated Brackets

Corticotomy PROCEDURE

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

Also known as: Piezosurgery, Decortication

Self-Ligating Brackets with Corticotomy

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age of patients: 17-28 years.
• Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
• The Little's Index of Irregularity is over 7 mm.
• There is no previous orthodontic treatment.
• The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
• The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).
• Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
• Overbite is between 0-4 mm.
• There is no skeletal constriction on the upper jaw.
• Full presence of all permanent teeth in the dental arch (except for third molars)

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (9)

• 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.

  PMID: 29101414 BACKGROUND

• 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.

  PMID: 27095145 BACKGROUND

• 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.

  PMID: 28224175 BACKGROUND

• 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.

  PMID: 29103440 BACKGROUND

• 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.

  PMID: 27761668 BACKGROUND

• 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.

  PMID: 27484605 BACKGROUND

• 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.

  PMID: 27129491 BACKGROUND

• 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.

  PMID: 21478298 BACKGROUND

• 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.

  PMID: 18929262 BACKGROUND

MeSH Terms

Interventions

Piezosurgery; Cerebral Decortication

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Heba Al-Ibrahim, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY CHAIR

• Issam Khoury, DDS MSc PhD

  Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

  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: August 22, 2018
• First Posted: August 27, 2018
• Study Start: August 15, 2018
• Primary Completion: November 10, 2019
• Study Completion: June 19, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)