AzTrials
AzTrials

Crowding, ToothNCT03310086

Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision

A study testing Traditional fixed appliance and Corticision in people with Crowding, Tooth, 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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Crowding, Tooth
What is being tested?
Traditional fixed appliance and Corticision
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSyria
Study dates
Jan 2017to 15 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 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Damascus University

    Damascus, 00963

Other trials in Syria

About this study

Official 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

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.

Read the detailed description

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.

Conditions
Crowding, Tooth
Being tested
Traditional fixed appliance, Corticision
Keywords
corticision, CBCT, Crowding
Medical subject headings
Malocclusion, Crowding

What participants receive

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

  • Traditional fixed applianceDevice

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

  • CorticisionProcedure or surgery

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

Study groups in NCT03310086
Study groupRoleWhat they receive
Traditional fixed applianceExperimentalFixed 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
Receives: Device: Traditional fixed appliance
Fixed appliance and corticisionExperimentalFixed 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
Receives: Device: Traditional fixed appliance; Procedure: Corticision

What is being measured

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

  1. Speed of lower teeth movement.

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

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

Secondary outcomes (2)

  1. Changes of lower teeth torque

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

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

  2. Changes of lower teeth tipping

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

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

Timeline

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

  1. First posted16 Oct 2017
  2. Study startJan 2017
  3. Primary completion20 Dec 2017
  4. Study completion15 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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310086
Sponsor's protocol ID
UDDS-Ortho-07-2017
Status last verified
Jul 2018
First submitted
9 Oct 2017
Last updated
30 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University

Publications

  • 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.

    PubMed 22135148

  • 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.

    PubMed 26599124

  • 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.

    PubMed 23273363

  • 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.

    PubMed 24182579

  • 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.

    PubMed 22812378

  • 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.

    PubMed 23810039

Questions about this trial

What is this clinical trial studying?

A study testing Traditional fixed appliance and Corticision in people with Crowding, Tooth, 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 8 inclusion and 6 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 lower teeth movement. (time frame: After the leveling and alignment stage of the lower teeth, which will take approximately 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 NCT03310086, which also lists 6 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in