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CompletedNCT04601662Updated Oct 26, 2020

Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth

An interventional study of Corticision and Traditional Non-accelerated Treatment in Crowding of Anterior Mandibular Teeth, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2020-10-26.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Mar 2017, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
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Study summary

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researchers used minimally invasive surgical methods like corticision, piezocision, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40%.

The effect of corticision as a minimally invasive procedure on root resorption and dehiscence formation during orthodontic tooth movement has not been studied yet.

Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Read the detailed description

Orthodontically induced external root resorption accompanying orthodontic treatment is defined as a microscopic loss of root tissue as a result of the inflammatory reaction that occurs in the area of application of orthodontic force. It can be diagnosed and measured using conventional radiography or cone-beam computed tomography (CBCT).

Dehiscence is a loss of alveolar bone on the facial (rarely lingual) aspect of a tooth that leaves a characteristic v-shaped, root-exposed defect from the cementoenamel junction apically. Bone dehiscence cannot be detected through conventional radiography or clinical examination. Actually, CBCT can be considered the best accessible technique providing 3D data.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No randomized controlled trial (RCT) has compared flapless corticision in the non-extraction-based orthodontic decrowding of lower anterior teeth (LAT) with the conventional treatment in terms of external apical root resorption (EARR) and dehiscence formation (DF).

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Conditions studied

  • Crowding of Anterior Mandibular Teeth

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03

In context

Crowding

88 studies on the registry are indexed under Crowding; 22 are open to participants now.

This study's enrollment of 52 is above the median of 36 across 74 interventional studies indexed under Crowding.

Browse Crowding studies →

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age range between 18 and 24 years
  2. Completion permanent dentition (except third molars)
  3. Mild to moderate crowding (2-6 mm according to Little's index)
  4. Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Exclusion criteria

Exclusion Criteria:

  1. Medical conditions that would affect tooth movement.
  2. Cases which to oral surgery.
  3. Previous orthodontic treatments.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Corticision

    Patients in this group will be subjected to corticision to accelerate orthodontic movement

    Procedure: Corticision

  • Active comparator
    Traditional treatment

    Patients in this group will undergo normal traditional treatment without any acceleration method.

    Other: Traditional Non-accelerated Treatment

Interventions

  • ProcedureCorticision

    A special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth

  • OtherTraditional Non-accelerated Treatment

    The normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods

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What researchers measure

Primary outcomes

  1. Change in Root Length

    Cone-beam computed tomography imaging will be used for the lower jaw. Root length will be measured for each root of the six lower anterior teeth The change will be calculated between 'before' and 'after' images in mm.

    Time frame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment

Secondary outcomes

  1. Change in Dehiscence Proportion

    Cone-beam computed tomography imaging will be used for the lower jaw. Any V-shaped bone defect located buccally or lingually in the lower anterior region involving bone margin is preliminarily identified as dehiscence. This is going to be measured and the proportion of the presence of such defects will be calculated on two different occasions (T1 and T2).

    Time frame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment

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Study locations

1 site
  • Orthodontic Department, University of Damascus Dental School
    Damascus, 00963, Syrian Arab Republic
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References and documents

Publications

  • Mandelaris GA, Neiva R, Chambrone L. Cone-Beam Computed Tomography and Interdisciplinary Dentofacial Therapy: An American Academy of Periodontology Best Evidence Review Focusing on Risk Assessment of the Dentoalveolar Bone Changes Influenced by Tooth Movement. J Periodontol. 2017 Oct;88(10):960-977. doi: 10.1902/jop.2017.160781. PubMed 28967331 ↗
  • Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29. PubMed 27129491 ↗
  • Charavet C, Lambert F, Lecloux G, Le Gall M. [Accelerated orthodontic treatment using corticotomies: what are the minimally invasive alternatives?]. Orthod Fr. 2019 Mar;90(1):5-12. doi: 10.1051/orthodfr/2019002. Epub 2019 Apr 17. French. PubMed 30994445 ↗
  • Makedonas D, Lund H, Hansen K. Root resorption diagnosed with cone beam computed tomography after 6 months and at the end of orthodontic treatment with fixed appliances. Angle Orthod. 2013 May;83(3):389-93. doi: 10.2319/042012-332.1. Epub 2012 Oct 23. PubMed 23092202 ↗
  • Samandara A, Papageorgiou SN, Ioannidou-Marathiotou I, Kavvadia-Tsatala S, Papadopoulos MA. Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis. Eur J Orthod. 2019 Jan 23;41(1):67-79. doi: 10.1093/ejo/cjy027. PubMed 29771300 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04601662
Responsible party
Sponsor
First posted
Oct 26, 2020
Start date
Mar 15, 2017
Primary completion
Nov 15, 2018
Completion
Feb 15, 2019
Last update
Oct 26, 2020

Study contacts

Mohamad Radwan Sirri, DDS MSc
principal investigator · PhD student, Orthodontics Department, University of Damascus Dental School
Ahmad S Burhan, DDS MSc PhD
study director · Professor of Orthodontics, University of Damascus, Damascus, Syria
Fehmieh R Nawaya, DDS MSc PhD
study director · Associate Professor of Pedodontics, Syrian Private University, Damascus, Syria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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