NCT05227859

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 25, 2022

Last Update Submit

January 11, 2026

Conditions

Keywords

LLLTPiezocisionCanine retractionAcceleration

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    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

    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

    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

    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

  • +1 more secondary outcomes

Study Arms (3)

Piezocision therapy

EXPERIMENTAL

In this group of patients, the canine will be retracted in association with piezocision.

Procedure: Piezocision

Low-level laser therapy

EXPERIMENTAL

In this group of patients, the canine will be retracted in association with LLLT.

Device: Low-level laser

Conventional treatment

ACTIVE COMPARATOR

In this group of patients, the canine will be retracted conventionally without any acceleration intervention.

Device: Conventional treatment

Interventions

PiezocisionPROCEDURE

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)

Piezocision therapy

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.

Low-level laser therapy

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.

Conventional treatment

Eligibility Criteria

Age17 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (5)

  • 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.

    PMID: 30559886BACKGROUND
  • 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.

    PMID: 25728102BACKGROUND
  • 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.

    PMID: 32990775BACKGROUND
  • 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.

    PMID: 33962809BACKGROUND
  • 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.

    PMID: 27021451BACKGROUND

MeSH Terms

Conditions

Overbite

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Doa'a Tahseen Alfailany, DDS

    Department of Orthodontics, University of Damascus Dental School, Syria

    PRINCIPAL INVESTIGATOR
  • Mohammad Y Hajeer, DDS MSc PhD

    Professor of Orthodontics, University of Damascus Dental School, Syria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 7, 2022

Study Start

November 8, 2020

Primary Completion

April 28, 2021

Study Completion

November 26, 2021

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations