Class II MalocclusionNCT05227859

Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement

A study testing Piezocision, Low-level laser and Conventional treatment in people with Class II Malocclusion, 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

Who is it for?: Ages 17 to 28 years
Conditions the study is for: Class II Malocclusion
What is being tested?: Piezocision, Low-level laser and Conventional treatment
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSyria
Study dates: 8 Nov 2020to 26 Nov 2021
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 17 to 28 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Adult healthy patients, Male and female, Age range: 17-28 years.
Class II Division 1 malocclusion :
Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7)
Overjet ≤10
Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
Mild to moderate crowding ≤ 4

Show all 13Show fewer

Permanent occlusion.
Existence of all the upper teeth (except third molars).
Good oral and periodontal health:
Probing depth < 4 mm
No radiographic evidence of bone loss.
Gingival index ≤ 1
Plaque index ≤ 1

Who cannot join

Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
Presence of primary teeth in the maxillary arch
Missing permanent maxillary teeth (except third molars).
Poor oral hygiene or Current periodontal disease:
Probing depth ≥ 4 mm
radiographic evidence of bone loss

Show all 9Show fewer

Gingival index > 1
Plaque index > 1
Patient had previous orthodontic treatment

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Orthodontics, University of Damascus Dental School
Damascus

Other trials in Syria

About this study

Official title: Assessment of the Effects of Piezocision and Low-level Laser Therapy on Orthodontic Tooth Movement During Canine Retraction and the Associated Dentoalveolar Changes: A Three-arm Randomized Controlled Clinical Trial

Sixty patients requiring extraction-based treatment of the maxillary first premolars, followed by retraction of the maxillary canines, will be randomly assigned to three groups: piezocision, low-level laser therapy, and control. In each group, canine retraction will be initiated after completion of the leveling and alignment phase, using closed nickel-titanium coil springs that apply 150 g of force per side. For anchorage, a soldered transpalatal arch will be used.

Pre- and post-distalization dental casts will be assessed to evaluate the rate of canine retraction, canine rotation, and anchorage loss over the follow-up period until a Class I canine relationship is achieved. Periodontal health will be assessed before and after canine retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, and probing depth.

Read the detailed description

Before enrollment of each subject in the study, they will undergo a comprehensive assessment to ensure their eligibility. The operator will inform them of the study's aim and request written informed consent.

At the end of the leveling and alignment stage, the upper first premolars will be extracted. The rectangular stainless steel archwires (0.019" × 0.025") will be inserted, and after one month, canine retraction will be initiated.

Regarding the Piezocision, after anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal to the upper canine, as well as at an equal distance from the upper canine and the 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done) Regarding low-level laser therapy (LLLT), a GaAlAs diode laser (wavelength: 810 nm; exposure time: 10 seconds per point) will be applied around the upper canine at 10 sites, buccally and palatally. The central portion of the extraction site will also be irradiated at four sites (2 buccally and two palatally). LLLT will be applied 5 times during the first month of canine retraction, then every 2 weeks until a Class I canine relationship is achieved.

The upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship is present on both sides.

Dental casts will be used to quantify the anteroposterior movement of the upper canines and first molars at 30-day intervals until the Class I canine relationship is achieved.

Conditions: Class II Malocclusion
Being tested: Piezocision, Low-level laser, Conventional treatment
Keywords: LLLT, Piezocision, Canine retraction, Acceleration
Medical subject headings: Overbite

What participants receive

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

PiezocisionProcedure or surgery
After anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done)
Low-level laserDevice
GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction, then every two weeks until class I canine relationship will be achieved.
Conventional treatmentDevice
The upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship in both sides.

Study groups in NCT05227859
Study group	Role	What they receive
Piezocision therapy	Experimental	In this group of patients, the canine will be retracted in association with piezocision. Receives: Procedure: Piezocision
Low-level laser therapy	Experimental	In this group of patients, the canine will be retracted in association with LLLT. Receives: Device: Low-level laser
Conventional treatment	Active comparator	In this group of patients, the canine will be retracted conventionally without any acceleration intervention. Receives: Device: Conventional treatment

What is being measured

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

Duration of upper canine retraction
Assessment will be performed by calculating the months required to achieve complete retraction of the upper canine retraction through clinical examination.
Measured: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to occur within four months in the experimental groups and seven months in the control group
Rate of retraction
Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.
Measured: Time Frame: The calculation of the rate of retraction will be done once the retraction procedures have finished. Completion of this procedure is expected to occur within 4 months in the experimental groups and 7 months in the control group.

Secondary outcomes (6)

Change in Molars' positions
The amount of distance being traveled by the first molars is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
Measured: T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months; and T4: at the end of retraction (expected to be within 4 months to 7 months))
Change in canine' rotation
The amount of the rotation of canine is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
Measured: T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months of retraction; and T4: at the end of retraction (expected to be within 4 months to 7 months)
Change in the plaque index
Assessment will be performed using a gingival probe to evaluate oral hygiene status in enrolled patients.
1. (0) = No plaque. B. (1) = A film of plaque stuck to the free gingival margin and adjacent area of the tooth.
2. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket.
3. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket.
Measured: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group
Change in the gingival index
Assessment will be achieved using a gingival probe to assess the status of the gingival tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar).
1. (0) = Normal gingiva. B. (1) = Mild inflammation: minor color change, slight oedema. No bleeding on probing.
2. (2) = Moderate inflammation: redness, oedema, glazing, and bleeding on probing.
3. (3) = Severe inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding.
Measured: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group
Change in the papillary bleeding index
Assessment will be achieved using a gingival probe to assess the status of periodontal tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar).
1. (0) = No bleeding. B. (1) = A single, discrete bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears.
2. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Measured: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group
Change in the probing depth
Assessment will be achieved using a gingival probe. It will be measured clinically as the distance from the free gingival margin to the gingival sulcus around the six maxillary anterior teeth and 2nd premolars.
Measured: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group

Timeline

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

8 Nov 202026 Nov 2021

First posted7 Feb 2022
Study start8 Nov 2020
Primary completion28 Apr 2021
Study completion26 Nov 2021

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 Class II MalocclusionStudies 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05227859
Sponsor's protocol ID: UDDS-Ortho-01-2022
Status last verified: Jan 2026
First submitted: 25 Jan 2022
Last updated: 13 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Abdelhameed AN, Refai WMM. Evaluation of the Effect of Combined Low Energy Laser Application and Micro-Osteoperforations versus the Effect of Application of Each Technique Separately On the Rate of Orthodontic Tooth Movement. Open Access Maced J Med Sci. 2018 Nov 15;6(11):2180-2185. doi: 10.3889/oamjms.2018.386. eCollection 2018 Nov 25.
PubMed 30559886
Rajasekaran UB, Krishna Nayak US. Effect of prostaglandin E1 versus corticotomy on orthodontic tooth movement: an in vivo study. Indian J Dent Res. 2014 Nov-Dec;25(6):717-21. doi: 10.4103/0970-9290.152170.
PubMed 25728102
Turker G, Yavuz I, Gonen ZB. Which method is more effective for accelerating canine distalization short term, low-level laser therapy or piezocision? A split-mouth study. J Orofac Orthop. 2021 Jul;82(4):236-245. doi: 10.1007/s00056-020-00250-6. Epub 2020 Sep 29.
PubMed 32990775
Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4.
PubMed 33962809
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

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 Class II Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Effects of Piezocision and Low-level Laser Therapy on Orthodontic Tooth Movement During Canine Retraction and the Associated Dentoalveolar Changes: A Three-arm Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT05227859
Acronym / sponsor ID: UDDS-Ortho-01-2022
Conditions: Class II Malocclusion
Keywords: LLLT, Piezocision, Canine retraction, Acceleration
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 8 Nov 2020 (actual)
Primary completion: 28 Apr 2021 (actual)
Study completion: 26 Nov 2021 (actual)
First posted: 7 Feb 2022 (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.

Detailed description

Dental casts will be used to quantify the anteroposterior movement of the upper canines and first molars at 30-day intervals until the Class I canine relationship is achieved.

Study design

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

Arm	Type	Receives
Piezocision therapy	Experimental	Procedure: PiezocisionIn this group of patients, the canine will be retracted in association with piezocision.
Low-level laser therapy	Experimental	Device: Low-level laserIn this group of patients, the canine will be retracted in association with LLLT.
Conventional treatment	Active comparator	Device: Conventional treatmentIn this group of patients, the canine will be retracted conventionally without any acceleration intervention.

Who may qualify

Ages: 17 to 28 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (13 listed)

Adult healthy patients, Male and female, Age range: 17-28 years.
Class II Division 1 malocclusion :
Permanent occlusion.
Existence of all the upper teeth (except third molars).
Good oral and periodontal health:

Key exclusion criteria (9 listed)

Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
Presence of primary teeth in the maxillary arch
Missing permanent maxillary teeth (except third molars).
Poor oral hygiene or Current periodontal disease:
Patient had previous orthodontic treatment

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
PiezocisionAfter anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done)	Procedure or surgery	Piezocision therapy
Low-level laserGaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction, then every two weeks until class I canine relationship will be achieved.	Device	Low-level laser therapy
Conventional treatmentThe upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship in both sides.	Device	Conventional treatment

Primary outcome

Duration of upper canine retraction
Time frame: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to occur within four months in the experimental groups and seven months in the control group
Assessment will be performed by calculating the months required to achieve complete retraction of the upper canine retraction through clinical examination.
Rate of retraction
Time frame: Time Frame: The calculation of the rate of retraction will be done once the retraction procedures have finished. Completion of this procedure is expected to occur within 4 months in the experimental groups and 7 months in the control group.
Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.

6 secondary outcomes

Change in Molars' positions
Time frame: T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months; and T4: at the end of retraction (expected to be within 4 months to 7 months))
Change in canine' rotation
Time frame: T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months of retraction; and T4: at the end of retraction (expected to be within 4 months to 7 months)
Change in the plaque index
Time frame: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group
Change in the gingival index
Time frame: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group
Change in the papillary bleeding index
Time frame: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group
Change in the probing depth
Time frame: T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group

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 13 Jan 2026.
Background: PubMed 30559886Abdelhameed AN, Refai WMM. Evaluation of the Effect of Combined Low Energy Laser Application and Micro-Osteoperforations versus the Effect of Application of Each Technique Separately On the Rate of Orthodontic Tooth Movement. Open Access Maced J Med Sci. 2018 Nov 15;6(11):2180-2185. doi: 10.3889/oamjms.2018.386. eCollection 2018 Nov 25.
Background: PubMed 25728102Rajasekaran UB, Krishna Nayak US. Effect of prostaglandin E1 versus corticotomy on orthodontic tooth movement: an in vivo study. Indian J Dent Res. 2014 Nov-Dec;25(6):717-21. doi: 10.4103/0970-9290.152170.
Background: PubMed 32990775Turker G, Yavuz I, Gonen ZB. Which method is more effective for accelerating canine distalization short term, low-level laser therapy or piezocision? A split-mouth study. J Orofac Orthop. 2021 Jul;82(4):236-245. doi: 10.1007/s00056-020-00250-6. Epub 2020 Sep 29.
Background: PubMed 33962809Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4.
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.
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.

Doa'a Tahseen Alfailany, DDS principal investigator

Department of Orthodontics, University of Damascus Dental School, Syria

Mohammad Y Hajeer, DDS MSc PhD study chair

Professor of Orthodontics, University of Damascus Dental School, 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 Piezocision, Low-level laser and Conventional treatment in people with Class II Malocclusion, 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 13 inclusion and 9 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 13 Jan 2026. 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?

Duration of upper canine retraction (time frame: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to occur within four months in the experimental groups and seven months in the control group). The study lists 2 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 NCT05227859, 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 13 Jan 2026.