NCT03310086

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

October 9, 2017

Last Update Submit

July 27, 2018

Conditions

Keywords

corticisionCBCTCrowding

Outcome Measures

Primary Outcomes (1)

  • Speed of lower teeth movement.

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

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

Secondary Outcomes (2)

  • Changes of lower teeth torque

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

  • Changes of lower teeth tipping

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

Study Arms (2)

Traditional fixed appliance

EXPERIMENTAL

Fixed orthodontic appliances will be applied for aligning and leveling of lower anterior teeth up to 19\*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022" Brackets

Device: Traditional fixed appliance

Fixed appliance and corticision

EXPERIMENTAL

Fixed orthodontic appliances with corticison will be applied for aligning and leveling of lower anterior teeth up to 19\*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022" Brackets

Device: Traditional fixed applianceProcedure: Corticision

Interventions

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

Fixed appliance and corticisionTraditional fixed appliance
CorticisionPROCEDURE

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

Fixed appliance and corticision

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related Publications (6)

  • Guo QY, Zhang SJ, Liu H, Wang CL, Wei FL, Lv T, Wang NN, Liu DX. Three-dimensional evaluation of upper anterior alveolar bone dehiscence after incisor retraction and intrusion in adult patients with bimaxillary protrusion malocclusion. J Zhejiang Univ Sci B. 2011 Dec;12(12):990-7. doi: 10.1631/jzus.B1100013.

  • Park YG. Corticision: A Flapless Procedure to Accelerate Tooth Movement. Front Oral Biol. 2016;18:109-17. doi: 10.1159/000351904. Epub 2015 Nov 24.

  • Ponder SN, Benavides E, Kapila S, Hatch NE. Quantification of external root resorption by low- vs high-resolution cone-beam computed tomography and periapical radiography: A volumetric and linear analysis. Am J Orthod Dentofacial Orthop. 2013 Jan;143(1):77-91. doi: 10.1016/j.ajodo.2012.08.023.

  • Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.

  • Castro IO, Alencar AH, Valladares-Neto J, Estrela C. Apical root resorption due to orthodontic treatment detected by cone beam computed tomography. Angle Orthod. 2013 Mar;83(2):196-203. doi: 10.2319/032112-240.1. Epub 2012 Jul 19.

  • Mathews DP, Kokich VG. Accelerating tooth movement: the case against corticotomy-induced orthodontics. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):5-13. doi: 10.1016/j.ajodo.2013.04.008. No abstract available.

MeSH Terms

Conditions

MalocclusionCrowding

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Study Officials

  • Ahmad S Burhan, PhD.

    Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 16, 2017

Study Start

January 1, 2017

Primary Completion

December 20, 2017

Study Completion

July 15, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

Locations