Which is Better Piezosurgery or Piezosurgery With Laser in Accelerating Orthodontic Tooth Movement

NCT ID: NCT05655169

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2021-12-20

Brief Summary

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Sixty patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary anterior teeth will be divided randomly into three groups: piezocision group, piezocision with low-level laser therapy group, and control group. In each group, after the levelling and alignment phase is completed, the rectangular stainless steel archwires (0.019" × 0.025") will be inserted, then after two weeks, the en masse retraction will be started via closed nickel-titanium coil springs applying 250 g of force per side. For anchorage, mini implants will be inserted between the second premolars and the first molar on each side.

Detailed Description

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Regarding the Piezocision, vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. The incisions will be 5 mm long and start 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8 mm in length. No suturing will be needed.

Regarding the piezocision with the later application of low-level laser therapy (LLLT):

After six weeks of piezosurgery, a diode laser (wavelength: 810 nm and exposure time of 10 seconds\\point) 10 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol: the root will be divided theoretically into two halves; gingival and cervical, and the laser will be applied in the center of each half from both buccal and palatal sides which means four application points and total energy of 16 Joules per tooth. LLLT irradiation will be performed in the sixth week after the onset of mass retraction (day 0). After that, irradiation is repeated on days 3, 7, and 14, then every two weeks, until the class I canine relationship is achieved and/or spaces lateral to incisors are closed

Conditions

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Angle Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Piezosurgery and low-level laser therapy

Piezocision will be applied in this group of patients using a piezosurgery knife and after six weeks of initial retraction, low-level laser therapy will be applied in this group of patients using a diode laser device.

Group Type EXPERIMENTAL

Piezosurgery and GaALAs diode laser

Intervention Type PROCEDURE

One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. The incisions will be 5 mm long and start 4 mm apical to the interdental papilla.

After six weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\\point) 10 seconds per point will be applied.

Piezosurgery only

Piezocision will be applied in this group of patients using a piezosurgery knife

Group Type EXPERIMENTAL

Piezosurgery

Intervention Type PROCEDURE

One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. The incisions will be 5 mm long and start 4 mm apical to the interdental papilla.

Traditional treatment without acceleration

In this group of patients, the en masse retraction will be conventional without any acceleration intervention.

Group Type ACTIVE_COMPARATOR

Fixed orthodontic appliance

Intervention Type OTHER

After the levelling and alignment phase is completed, the rectangular stainless steel archwires (0.019" × 0.025") will be inserted, then after two weeks, the en masse retraction will be started via closed nickel-titanium coil springs applying 250 g of force per side.

Interventions

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Piezosurgery and GaALAs diode laser

One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. The incisions will be 5 mm long and start 4 mm apical to the interdental papilla.

After six weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\\point) 10 seconds per point will be applied.

Intervention Type PROCEDURE

Piezosurgery

One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. The incisions will be 5 mm long and start 4 mm apical to the interdental papilla.

Intervention Type PROCEDURE

Fixed orthodontic appliance

After the levelling and alignment phase is completed, the rectangular stainless steel archwires (0.019" × 0.025") will be inserted, then after two weeks, the en masse retraction will be started via closed nickel-titanium coil springs applying 250 g of force per side.

Intervention Type OTHER

Eligibility Criteria

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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. The patient had previous orthodontic treatment
Minimum Eligible Age

17 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mudar Mohammad Mousa, DDS

Role: PRINCIPAL_INVESTIGATOR

Department of orthodontics, Damascus University, Syria

Mohammad Y. Hajeer, DDS,MSc,PhD

Role: STUDY_DIRECTOR

Department of orthodontics, Damascus University, Syria

Locations

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University of Damascus

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 30559886 (View on PubMed)

Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.

Reference Type BACKGROUND
PMID: 32909702 (View on PubMed)

Hatrom AA, Zawawi KH, Al-Ali RM, Sabban HM, Zahid TM, Al-Turki GA, Hassan AH. Effect of piezocision corticotomy on en-masse retraction. Angle Orthod. 2020 Sep 1;90(5):648-654. doi: 10.2319/092719-615.1.

Reference Type BACKGROUND
PMID: 33378476 (View on PubMed)

Al-Ibrahim HM, Hajeer MY, Alkhouri I, Zinah E. Leveling and alignment time and the periodontal status in patients with severe upper crowding treated by corticotomy-assisted self-ligating brackets in comparison with conventional or self-ligating brackets only: a 3-arm randomized controlled clinical trial. J World Fed Orthod. 2022 Feb;11(1):3-11. doi: 10.1016/j.ejwf.2021.09.002. Epub 2021 Oct 21.

Reference Type BACKGROUND
PMID: 34688577 (View on PubMed)

Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4.

Reference Type BACKGROUND
PMID: 33158633 (View on PubMed)

Mousa MM, Hajeer MY, Alam MK, Aljabban O, Almahdi WH. Evaluation of low-level laser therapy and piezocision in the en-masse retraction of upper anterior teeth. Eur J Orthod. 2025 Apr 8;47(3):cjaf026. doi: 10.1093/ejo/cjaf026.

Reference Type DERIVED
PMID: 40353446 (View on PubMed)

Other Identifiers

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UDDS-Ortho-14-2022

Identifier Type: -

Identifier Source: org_study_id

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