Malocclusion, Angle Class II, Division 1NCT03659188

Comparison Between Two Methods in the Acceleration of the Retraction of Upper Canines

A study testing Cortico-alveolar perforations and Traditional Corticotomy in people with Malocclusion, Angle Class II, Division 1, 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

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Trial summary

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure… Read more about this study

Who is it for?: Ages 18 to 27 years
Conditions the study is for: Malocclusion, Angle Class II, Division 1
What is being tested?: Cortico-alveolar perforations and Traditional Corticotomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteSyria
Study dates: 2 Sep 2018to 12 Aug 2020
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 27 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age between 18-27 years
Patients who have malocclusion class II type I and who require first-premolar extraction with:
Dentoalveolar class II type I with ANB between 5 and 9 degrees.
Protrusion between (5-10 mm)
Overbite between (0-4)
Vertical dimension is normal or over the normal range

Show all 12Show fewer

Mild to moderate crowding
All patients should have complete permanent occlusion on the maxilla
All patients should have normal periodontal tissue and good oral health, which will be assessed by:
Depth of the gingival pocket does not exceed 4 mm
Plaque index does not exceed 1
Gingival index does not exceed 1

Who cannot join

Patients in which oral surgery under local anesthesia is contraindicated due to medical, psychological, or social reasons.
Patients who have a general health problem that affects dental movement
Patients who have undergone previous orthodontic treatment
Patients with mixed occlusion
Patients who have lost one or more of their teeth since birth or who have one of the permanent teeth extracted (except the third molar)
Patients who have bad oral health or active periodontal disease

Trial locations and contacts

1 site in 1 country.

Syria1 site

Orthodontic Department, University of Damascus Dental School
Damascus, DM20AM18

Other trials in Syria

About this study

Official title: Evaluation of the Efficiency and Efficacy of Flapless Cortico-alveolar Perforations Using Mechanical Drills Versus Traditional Corticotomy in the Retraction of Upper Canines: a Three-arm Randomized Controlled Clinical Trial

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included.

Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched.

The aim of this study is to compare flapless bone cutting by mechanical drills to evaluate the acceleration of the retraction of upper canines versus traditional bone cutting by piezo-surgery in comparison with a control group without bone cutting after extraction of upper first premolars in class II type I patients.

Conditions: Malocclusion, Angle Class II, Division 1
Being tested: Cortico-alveolar perforations, Traditional Corticotomy
Medical subject headings: Malocclusion, Angle Class II

What participants receive

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

Cortico-alveolar perforationsProcedure or surgery
Also called Flapless corticotomy
Mechanical drills will be used on a handpiece
Traditional CorticotomyProcedure or surgery
Piezo-surgery will be employed following flaps' elevation.

Study groups in NCT03659188
Study group	Role	What they receive
Cortico-alveolar perforations	Experimental	Patients will undergo orthodontic treatment plus cortico-alveolar perforations. Receives: Procedure: Cortico-alveolar perforations
Traditional Corticotomy	Experimental	Patients will undergo orthodontic treatment plus an acceleration procedure employing traditional corticotomy. Receives: Procedure: Traditional Corticotomy
Control	No intervention	Patients will undergo orthodontic treatment in which canine retraction will be accomplished using the standard sliding mechanism without any acceleration procedures.

What is being measured

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

Change in Canine Retraction Speed
The rate at which canine is going to be retracted (mm/month) in each group will be calculated.
This outcome will be measured by the following steps:
1. Drawing a projection from the upper canine apex to the middle palatal bone line.
2. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line.
3. Measuring the distance (mm) between the two orthogonal projections.
4. The rate of canine retraction will be measured by dividing the distance between the two orthogonal projections by the time elapsed between assessment times.
Measured: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Change in Anchorage Loss
Anchorage loss in related the mesial drift of the first molar. This outcome will be measured by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The mesial migration of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.
Measured: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Change in Canine Rotation
The angle between the middle palatal bone and the line through the mesial and distal edges of the canine will be measured on each side. The rotation will be assessed by calculating the difference between the angles on two different times. Then, the speed of rotation will be calculated by dividing the rotation angle (degrees) by time that elapsed between assessment times.
Measured: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Change in Canine Axis
The changes in the canine axis during retraction will be studied by calculating canine angulation (arithmetic mean of the angulation of the right and left upper canine axis with the anterior cranial base plane) on lateral cephalometric radiographs. The difference between the canine angulation on T1 and T2 will be calculated after comparing the two cephalometric using Viewbox version 4.0.0.98.
Measured: T1: at the end of the alignment stage (which is expected within 3 to 4 months); T2: at the end of the canine retraction stage (which is expected to occur with 4 to five months following the onset of this stage).

Timeline

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

2 Sep 201812 Aug 2020

First posted6 Sep 2018
Study start2 Sep 2018
Primary completion15 Oct 2019
Study completion12 Aug 2020

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 Malocclusion, Angle Class II, Division 1Studies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03659188
Sponsor's protocol ID: UDDS-Ortho-18-2018
Status last verified: Mar 2023
First submitted: 3 Sep 2018
Last updated: 31 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Abbas NH, Sabet NE, Hassan IT. Evaluation of corticotomy-facilitated orthodontics and piezocision in rapid canine retraction. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):473-80. doi: 10.1016/j.ajodo.2015.09.029.
PubMed 27021451
Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
PubMed 27696311
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
Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19.
PubMed 25989211
Buyuk SK, Yavuz MC, Genc E, Sunar O. A novel method to accelerate orthodontic tooth movement. Saudi Med J. 2018 Feb;39(2):203-208. doi: 10.15537/smj.2018.2.21235.
PubMed 29436571

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malocclusion, Angle Class II, Division 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficiency and Efficacy of Flapless Cortico-alveolar Perforations Using Mechanical Drills Versus Traditional Corticotomy in the Retraction of Upper Canines: a Three-arm Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03659188
Acronym / sponsor ID: UDDS-Ortho-18-2018
Conditions: Malocclusion, Angle Class II, Division 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 2 Sep 2018 (actual)
Primary completion: 15 Oct 2019 (actual)
Study completion: 12 Aug 2020 (actual)
First posted: 6 Sep 2018 (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.

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cortico-alveolar perforations	Experimental	Procedure: Cortico-alveolar perforationsPatients will undergo orthodontic treatment plus cortico-alveolar perforations.
Traditional Corticotomy	Experimental	Procedure: Traditional CorticotomyPatients will undergo orthodontic treatment plus an acceleration procedure employing traditional corticotomy.
Control	No intervention	–Patients will undergo orthodontic treatment in which canine retraction will be accomplished using the standard sliding mechanism without any acceleration procedures.

Who may qualify

Ages: 18 to 27 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Age between 18-27 years
Patients who have malocclusion class II type I and who require first-premolar extraction with:
Dentoalveolar class II type I with ANB between 5 and 9 degrees.
Protrusion between (5-10 mm)
Overbite between (0-4)

Key exclusion criteria (6 listed)

Patients in which oral surgery under local anesthesia is contraindicated due to medical, psychological, or social reasons.
Patients who have a general health problem that affects dental movement
Patients who have undergone previous orthodontic treatment
Patients with mixed occlusion
Patients who have lost one or more of their teeth since birth or who have one of the permanent teeth extracted (except the third molar)

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
Cortico-alveolar perforationsAlso: Flapless corticotomyMechanical drills will be used on a handpiece	Procedure or surgery	Cortico-alveolar perforations
Traditional CorticotomyPiezo-surgery will be employed following flaps' elevation.	Procedure or surgery	Traditional Corticotomy

Primary outcome

Change in Canine Retraction Speed
Time frame: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
The rate at which canine is going to be retracted (mm/month) in each group will be calculated. This outcome will be measured by the following steps: 1. Drawing a projection from the upper canine apex to the middle palatal bone line. 2. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. 3. Measuring the distance (mm) between the two orthogonal projections. 4. The rate of canine retraction will be measured by dividing the distance between the two orthogonal projections by the time elapsed between assessment times.
Change in Anchorage Loss
Time frame: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Anchorage loss in related the mesial drift of the first molar. This outcome will be measured by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The mesial migration of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.
Change in Canine Rotation
Time frame: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
The angle between the middle palatal bone and the line through the mesial and distal edges of the canine will be measured on each side. The rotation will be assessed by calculating the difference between the angles on two different times. Then, the speed of rotation will be calculated by dividing the rotation angle (degrees) by time that elapsed between assessment times.
Change in Canine Axis
Time frame: T1: at the end of the alignment stage (which is expected within 3 to 4 months); T2: at the end of the canine retraction stage (which is expected to occur with 4 to five months following the onset of this stage).
The changes in the canine axis during retraction will be studied by calculating canine angulation (arithmetic mean of the angulation of the right and left upper canine axis with the anterior cranial base plane) on lateral cephalometric radiographs. The difference between the canine angulation on T1 and T2 will be calculated after comparing the two cephalometric using Viewbox version 4.0.0.98.

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 31 Mar 2023.
Background: PubMed 27021451Abbas NH, Sabet NE, Hassan IT. Evaluation of corticotomy-facilitated orthodontics and piezocision in rapid canine retraction. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):473-80. doi: 10.1016/j.ajodo.2015.09.029.
Background: PubMed 27696311Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
Background: PubMed 24182579Alikhani 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.
Background: PubMed 25989211Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19.
Background: PubMed 29436571Buyuk SK, Yavuz MC, Genc E, Sunar O. A novel method to accelerate orthodontic tooth movement. Saudi Med J. 2018 Feb;39(2):203-208. doi: 10.15537/smj.2018.2.21235.
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.

Mohammad Al-Bitar, DDS MSc principal investigator

MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

Mohammad Y Hajeer, DDS MSc PhD study director

Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Bassel Brad, DDS MSc PhD study director

Associate Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, 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 Cortico-alveolar perforations and Traditional Corticotomy in people with Malocclusion, Angle Class II, Division 1, 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 12 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 31 Mar 2023. 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 Canine Retraction Speed (time frame: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months). The study lists 4 primary outcomes in all. 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 NCT03659188, 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 31 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.