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Treatment of Crowding Without Extraction Using Self Ligating Brackets

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ClinicalTrials.gov Identifier: NCT02996292
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Crowding Device: Traditional brackets Device: Active self-ligating brackets Device: Passive self-ligating brackets Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Self-ligating Brackets Using CBCT Randomized Controlled Trial
Actual Study Start Date : September 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : July 19, 2018

Arm Intervention/treatment
Experimental: Traditional brackets
Fixed 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
Device: Traditional brackets
Treating of crowding using traditional brackets

Experimental: Active self-ligating brackets
Fixed 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"
Device: Active self-ligating brackets
Treating of crowding using active self-ligating brackets

Experimental: Passive self-ligating brackets
Fixed 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"
Device: Passive self-ligating brackets
Treating of crowding using passive self-ligating brackets




Primary Outcome Measures :
  1. Speed of alignment [ Time Frame: After 9 months ]
    Speed of alignment will be measured and compared between the groups.


Secondary Outcome Measures :
  1. Changes of the torque and tipping of teeth [ Time Frame: Evaluation before and after alignment and leveling teeth. (after 9 months) ]
    The torque and tipping of teeth will be evaluated before and after treatment and compared between the groups using CBCT images.

  2. Changes of widths and depths of the dental arches [ Time Frame: Evaluation before and after alignment and leveling teeth. (after 9 months) ]
    Changes of dental arches dimensions will be measured and compared between groups.

  3. External apical root resorption [ Time Frame: After 9 months ]
    External apical root resorption of each tooth on CBCT images (frequencies) after treatment.



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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996292


Locations
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Syrian Arab Republic
Damascus University
Damascus, Syrian Arab Republic
Sponsors and Collaborators
Damascus University
Investigators
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Study Chair: Ahmad S Burhan, PhD. Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Publications of Results:

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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02996292     History of Changes
Other Study ID Numbers: UDDS-Ortho-03-2016
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will be only available to the researchers in the department of Orthodontics, Damascus University

Keywords provided by Damascus University:
Crowding
Self ligating
CBCT
RCT