Crowding of Anterior Mandibular TeethNCT04601662
Evaluation of the Root Resorption and Dehiscence Formation Between Two Methods of Leveling and Alignment of Lower Teeth
A study testing Corticision and Traditional Non-accelerated Treatment in people with Crowding of Anterior Mandibular Teeth, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- Corticision and Traditional Non-accelerated Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSyria
- Study dates
- 15 Mar 2017to 15 Feb 2019
- 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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 18 and 24 years
- Completion permanent dentition (except third molars)
- Mild to moderate crowding (2-6 mm according to Little's index)
- Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
Who cannot join
- Medical conditions that would affect tooth movement.
- Cases which contraindication to oral surgery.
- Previous orthodontic treatments.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Orthodontic Department, University of Damascus Dental School
Damascus, 00963
About this study
Official title: Evaluation of Corticision-Based Acceleration of Lower Anterior Teeth Alignment on Root Resorption and Dehiscence Formation Using CBCT
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%.
Read more
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).
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- Corticision, Traditional Non-accelerated Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticisionProcedure or surgery
A special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth
Traditional Non-accelerated TreatmentOther
The normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods
| Study group | Role | What they receive |
|---|---|---|
| Corticision | Experimental | Patients in this group will be subjected to corticision to accelerate orthodontic movement Receives: Procedure: Corticision |
| Traditional treatment | Active comparator | Patients in this group will undergo normal traditional treatment without any acceleration method. Receives: Other: Traditional Non-accelerated Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start15 Mar 2017
- Primary completion15 Nov 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crowding of Anterior Mandibular TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad Radwan Sirri, DDS MSc, Principal investigator, PhD student, Orthodontics Department, University of Damascus Dental SchoolAhmad S Burhan, DDS MSc PhD, Study director, Professor of Orthodontics, University of Damascus, Damascus, SyriaFehmieh R Nawaya, DDS MSc PhD, Study director, Associate Professor of Pedodontics, Syrian Private University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601662
- Sponsor's protocol ID
- UDDS-Ortho-06-2020
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28967331Charavet 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 27129491Charavet 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 30994445Makedonas 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 23092202Samandara 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corticision-Based Acceleration of Lower Anterior Teeth Alignment on Root Resorption and Dehiscence Formation Using CBCT
- ClinicalTrials.gov ID
- NCT04601662
- Acronym / sponsor ID
- UDDS-Ortho-06-2020
- Conditions
- Crowding of Anterior Mandibular Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticision | Experimental | Procedure: CorticisionPatients in this group will be subjected to corticision to accelerate orthodontic movement |
| Traditional treatment | Active comparator | Other: Traditional Non-accelerated TreatmentPatients in this group will undergo normal traditional treatment without any acceleration method. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range between 18 and 24 years
- Completion permanent dentition (except third molars)
- Mild to moderate crowding (2-6 mm according to Little's index)
- Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
Key exclusion criteria (3 listed)
- Medical conditions that would affect tooth movement.
- Cases which contraindication to oral surgery.
- Previous orthodontic treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticisionA special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth | Procedure or surgery | Corticision |
| Traditional Non-accelerated TreatmentThe normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods | Other | Traditional treatment |
Primary outcome
Change in Root Length
Time frame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
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.
1 secondary outcome
Change in Dehiscence Proportion
Time frame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background: PubMed 28967331Mandelaris 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.
- Background: PubMed 27129491Charavet 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.
- Background: PubMed 30994445Charavet 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.
- Background: PubMed 23092202Makedonas 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.
- Background: PubMed 29771300Samandara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticision and Traditional Non-accelerated Treatment in people with Crowding of Anterior Mandibular Teeth, 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 4 inclusion and 3 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 26 Oct 2020. 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?
Change in Root Length (time frame: T1: one day before the beginning of the orthodontic treatment, T2: exactly at 12 months following the onset of orthodontic treatment). 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 NCT04601662, which also lists 5 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 26 Oct 2020.