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Completed

NCT Number: NCT03310086

Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

This experimental study will evaluate the effect of corticision on accelerating the leveling and alignment of lower crowded incisors compared with the control untreated group using cone beam computed tomography.

The study sample will consist of 26 patients with less than 6 mm crowding. The sample will be allocated randomly into two experimental groups.

The brackets and passive SS wire will be applied with radiographic metal guides between each tooth to allow for accurate corticision site 2 mm below the gingival papilla and to prevent tooth roots injury. The dentoalveolar changes occurring after leveling and alignment of lower anterior teeth will be evaluated using CBCT radiographs, Frequency, degree of root resorption, and the incidence of bone dehiscence will be assessed in relation to initial situation.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, 00963, Syria

About this study

Crowding is the most common form of malocclusion. Different methods have been used to resolve crowding, including extraction and nonextraction. Corticision is an important methods to accelerate tooth movement in crowded cases. Cortical bone incision without flap elevation enhances turnover rate of surrounding structures and decreases the time for leveling and alignment. In orthodontics, CBCT imaging has been applied to evaluate impacted teeth and root resorption. But the data are very rare regarding the application of CBCT in tooth movement. So CBCT will be used in this research to evaluate the amount of external apical root resorption (EARR) and presence of dehiscence in the lower anterior teeth in the crowded cases. Furthermore, the duration of alignment will be compared between corticision group and non-corticision group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients age 18 years or more
  • complete permanent dentition with second molars
  • crowding of less than 6 mm
  • good healthy patients without systematic diseases
  • absence of spaces in the lower dental arch
  • orthodontic treatment protocol does not required extraoral appliances, intraoral elastics, and expansion during leveling and alignment in the lower arch
  • good oral hygiene
  • absence of periodontal lesion

Exclusion criteria

  • patients with syndromes, clefts, or craniofacial abnormalities or systematic diseases
  • poor oral hygiene or periodontal lesion
  • previous orthodontic treatment.
  • Inability for brackets bonding in lower anterior teeth
  • presence of extreme skeletal discrepancy in vertical , transverse and anteroposterior relations
  • Delay rebonding of any loosing brackets for more than one week in the lower anterior teeth

Treatment and study plan

Traditional fixed appliance

Device

aligning and leveling of lower anterior teeth using traditional fixed appliance.

Corticision

Procedure

Corticison, cortical bone incision without flap elevation, will be applied to the lower anterior teeth

Primary outcomes

  1. Speed of lower teeth movement.

    Time frame: After the leveling and alignment stage of the lower teeth, which will take approximately 9 months

    The speed of lower teeth movement during leveling and alignment stage will be measured and compared between groups.

Secondary outcomes

  1. Changes of lower teeth torque

    Time frame: Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months

    The torque changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.

  2. Changes of lower teeth tipping

    Time frame: Changes will be evaluated before and after the lower teeth leveling and alignment stage, which will take approximately 8 months

    The tipping changes of the lower teeth will be evaluated and compared between the 2 groups using CBCT.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Efficiency of Corticision on Accelerating of Leveling and Alignment Lower Crowded Incisors Using Cone Beam Computed Tomography - A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 16, 2017
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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