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Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement

Primary Purpose

Class II Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Piezocision
Low-level laser
Conventional treatment
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion focused on measuring LLLT, Piezocision, Canine retraction, Acceleration

Eligibility Criteria

17 Years - 28 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult healthy patients, Male and female, Age range: 17-28 years.
  2. 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
  3. Permanent occlusion.
  4. Existence of all the upper teeth (except third molars).
  5. Good oral and periodontal health:

    • Probing depth < 4 mm
    • No radiographic evidence of bone loss.
    • Gingival index ≤ 1
    • Plaque index ≤ 1

Exclusion Criteria:

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

    • Probing depth ≥ 4 mm
    • radiographic evidence of bone loss
    • Gingival index > 1
    • Plaque index > 1
  5. Patient had previous orthodontic treatment

Sites / Locations

  • Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Piezocision therapy

Low-level laser therapy

Conventional treatment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 25, 2022
Last Updated
February 3, 2022
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05227859
Brief Title
Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 8, 2020 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
November 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Sixty patients need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into three groups: piezocision group, low-level laser therapy group, and control group. In each group, the canine retraction will be started after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side. For anchorage, a soldered trans-palatal arch will be used. Pre- and post distalization dental casts will be assessed to study the rate of canine retraction, as well as, canine rotation and anchorage loss over a follow-up period until a class I canine relationship is achieved.
Detailed Description
Before enrollment of each subject into the study, they will be examined completely to ensure their eligibility for this study. The operator will inform them about the aim of the study and ask them to provide written informed consent. At the end of leveling and alignment stage, the upper first premolars will be extracted. The rectangular stainless steel archwires (0.019" × 0.025") will be inserted, then after one month, the canine retraction will be started. Regarding the Piezocision, 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) Regarding the low-level laser therapy (LLLT): 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. 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. Dental casts will be used for the quantification of the anteroposterior movement of the upper canine and the first molars every 30 days until the class I canine relationship will be achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
LLLT, Piezocision, Canine retraction, Acceleration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piezocision therapy
Arm Type
Experimental
Arm Description
In this group of patients, the canine will be retracted in association with piezocision.
Arm Title
Low-level laser therapy
Arm Type
Experimental
Arm Description
In this group of patients, the canine will be retracted in association with LLLT.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
In this group of patients, the canine will be retracted conventionally without any acceleration intervention.
Intervention Type
Procedure
Intervention Name(s)
Piezocision
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Low-level laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of upper canine retraction
Description
Assessment will be performed by calculating the months required to achieve complete retraction of the upper canine retraction through clinical examination.
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
Title
Rate of retraction
Description
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
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 Outcome Measure Information:
Title
Change in Molars' positions
Description
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.
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))
Title
Change in canine' rotation
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doa'a Tahseen Alfailany, DDS
Organizational Affiliation
Department of Orthodontics, University of Damascus Dental School, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, University of Damascus Dental School, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30559886
Citation
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.
Results Reference
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PubMed Identifier
25728102
Citation
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.
Results Reference
background
PubMed Identifier
32990775
Citation
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.
Results Reference
background
PubMed Identifier
33962809
Citation
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.
Results Reference
background
PubMed Identifier
27021451
Citation
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.
Results Reference
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Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement

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