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

November 19, 2020 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Orthodontics, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 28 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Self-Ligating Brackets
Patients will be treated using self-ligating brackets to achieve proper alignment of teeth
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.
Other Names:
  • SLBs
EXPERIMENTAL: Self-Ligating Brackets with Corticotomy
Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment.
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.
Other Names:
  • SLBs
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.
Other Names:
  • Piezosurgery
  • Decortication
ACTIVE_COMPARATOR: Traditionally-Ligated Brackets
Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth
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.
Other Names:
  • Non-SLBs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Alignment
Time Frame: This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months)
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
Time Frame: 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)
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
Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
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
Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
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
Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
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
Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
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
Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Heba Al-Ibrahim, DDS, MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
  • Study Director: Issam Khoury, DDS MSc PhD, Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 15, 2018

Primary Completion (ACTUAL)

November 10, 2019

Study Completion (ACTUAL)

June 19, 2020

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (ACTUAL)

August 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-10-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malocclusion of Anterior Teeth

Clinical Trials on Self-Ligating Brackets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe