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CrowdingNCT02996292

Treatment of Crowding Without Extraction Using Self Ligating Brackets

A study testing Traditional brackets, Active self-ligating brackets and Passive self-ligating brackets in people with Crowding, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This experimental study will evaluate the effect of active and passive self-ligating brackets in treatment of crowding, compared with the control group of conventional brackets in class I malocclusion without extraction. The study sample will consist of 66 patients with 3-6mm crowding. Read more about this study

Who is it for?
Ages 14 to 24 years
Conditions the study is for
Crowding
What is being tested?
Traditional brackets, Active self-ligating brackets and Passive self-ligating brackets
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSyria
Study dates
Sep 2016to 19 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • patients permanent dentition stage.
  • crowding up to 6 mm
  • Class I relationship.
  • Good oral hygiene.

Who cannot join

  • Poor oral hygiene.
  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Class II or III skeletal anteroposterior relationship.
  • Crowding less than 3mm and more than 6mm.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Damascus University

    Damascus

Other trials in Syria

About this study

Official title: Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Self-ligating Brackets Using CBCT Randomized Controlled Trial

This experimental study will evaluate the effect of active and passive self-ligating brackets in treatment of crowding, compared with the control group of conventional brackets in class I malocclusion without extraction.

The study sample will consist of 66 patients with 3-6mm crowding. The sample will be allocated randomly into two experimental groups, in addition to a control group.

The brackets will be applied using indirect bonding method for all patients. The dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using CBCT radiographs; pre and post- treatment changes for each group will be evaluated individually.

Read the detailed description

Producing of modern and various brackets systems both self- ligating and conventional make the 3 dimensional important in order to evaluate the root positions and to investigate EARR in multi root teeth, so the research will depend on CBCT to carry out these purposes in our study. Beside to compare the duration of alignment among groups.

Fixed appliances will be applied into three groups as 1. Active self ligating brackets (ASLB), 2. Passive self ligating brackets (PSLB), 3. Conventional brackets (CB) until reach to wire 19*25 S.S upper and lower. During leveling, thermal activated wires will be used in all patients.

CBCT images will be done before and after leveling and alignment of teeth to compare dentoalveolar changes between study groups.

Conditions
Crowding
Being tested
Traditional brackets, Active self-ligating brackets, Passive self-ligating brackets
Keywords
Crowding, Self ligating, CBCT, RCT
Medical subject headings
Crowding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional bracketsDevice

    Treating of crowding using traditional brackets

  • Active self-ligating bracketsDevice

    Treating of crowding using active self-ligating brackets

  • Passive self-ligating bracketsDevice

    Treating of crowding using passive self-ligating brackets

Study groups in NCT02996292
Study groupRoleWhat they receive
Traditional bracketsExperimentalFixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022" Brackets
Receives: Device: Traditional brackets
Active self-ligating bracketsExperimentalFixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using active self-ligating brackets; American orthodontics active self-ligating Empower® MBT 0.022"
Receives: Device: Active self-ligating brackets
Passive self-ligating bracketsExperimentalFixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using passive self-ligating brackets; American orthodontics passive self-ligating Empower® MBT 0.022"
Receives: Device: Passive self-ligating brackets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speed of alignment

    Speed of alignment will be measured and compared between the groups.

    Measured: After 9 months

Secondary outcomes (3)

  1. Changes of the torque and tipping of teeth

    The torque and tipping of teeth will be evaluated before and after treatment and compared between the groups using CBCT images.

    Measured: Evaluation before and after alignment and leveling teeth. (after 9 months)

  2. Changes of widths and depths of the dental arches

    Changes of dental arches dimensions will be measured and compared between groups.

    Measured: Evaluation before and after alignment and leveling teeth. (after 9 months)

  3. External apical root resorption

    External apical root resorption of each tooth on CBCT images (frequencies) after treatment.

    Measured: After 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionNov 2017
  4. Study completion19 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02996292
Sponsor's protocol ID
UDDS-Ortho-03-2016
Status last verified
Jul 2018
First submitted
29 Nov 2016
Last updated
30 Jul 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Individual participant data will be only available to the researchers in the department of Orthodontics, Damascus University

Publications

  • Badawi HM, Toogood RW, Carey JP, Heo G, Major PW. Torque expression of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2008 May;133(5):721-8. doi: 10.1016/j.ajodo.2006.01.051.

    PubMed 18456146

  • Chan EK, Darendeliler MA, Petocz P, Jones AS. A new method for volumetric measurement of orthodontically induced root resorption craters. Eur J Oral Sci. 2004 Apr;112(2):134-9. doi: 10.1111/j.1600-0722.2004.00118.x.

    PubMed 15056110

  • Chen SS, Greenlee GM, Kim JE, Smith CL, Huang GJ. Systematic review of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):726.e1-726.e18; discussion 726-7. doi: 10.1016/j.ajodo.2009.11.009.

    PubMed 20685517

  • Garcia-Figueroa MA, Raboud DW, Lam EW, Heo G, Major PW. Effect of buccolingual root angulation on the mesiodistal angulation shown on panoramic radiographs. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):93-9. doi: 10.1016/j.ajodo.2006.07.034.

    PubMed 18617108

  • Lagravere MO, Carey J, Toogood RW, Major PW. Three-dimensional accuracy of measurements made with software on cone-beam computed tomography images. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):112-6. doi: 10.1016/j.ajodo.2006.08.024.

    PubMed 18617110

  • Morina E, Eliades T, Pandis N, Jager A, Bourauel C. Torque expression of self-ligating brackets compared with conventional metallic, ceramic, and plastic brackets. Eur J Orthod. 2008 Jun;30(3):233-8. doi: 10.1093/ejo/cjn005.

    PubMed 18540011

  • Sifakakis I, Pandis N, Makou M, Eliades T, Bourauel C. A comparative assessment of the forces and moments generated at the maxillary incisors between conventional and self-ligating brackets using a reverse curve of Spee NiTi archwire. Aust Orthod J. 2010 Nov;26(2):127-33.

    PubMed 21175021

Questions about this trial

What is this clinical trial studying?

A study testing Traditional brackets, Active self-ligating brackets and Passive self-ligating brackets in people with Crowding, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speed of alignment (time frame: After 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02996292, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.

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