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NCT Number: NCT02996292

Treatment of Crowding Without Extraction Using Self Ligating Brackets

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.

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Key information

Conditions

Crowding Behavior Spatial Behavior

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional brackets

Device

Treating of crowding using traditional brackets

Active self-ligating brackets

Device

Treating of crowding using active self-ligating brackets

Passive self-ligating brackets

Device

Treating of crowding using passive self-ligating brackets

Primary outcomes

  1. Speed of alignment

    Time frame: After 9 months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 19, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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