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

NCT05655169 | Completed DMC

• 1 other identifier: UDDS-Ortho-14-2022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Angle Class II

Outcome Measures

Primary Outcomes (4)

• The rate of en-masse retraction of upper anterior teeth

  The rate of en-masse retraction of upper anterior teeth (mm/month) in each group will be calculated. This outcome will be measured by the following steps: Drawing a projection from the upper canine apex to the middle palatal bone line. Drawing a projection from the upper central incisor edge to the middle palatal bone line. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. Measuring the distance (mm) between the canine apex and third palatal rugae projections. Measuring the distance (mm) between the central incisor edge and third palatal rugae projections. The rate of en-masse retraction will be measured by dividing the distance between the canine apex/central incisor edge projections and the third palatal rugae projection by the time elapsed between assessment times.

  This will be assessed at the end of the active treatment, which is expected to occur within five months

• Change in the anteroposterior movement of the molar

  The anteroposterior movement of the molar (mm/month) in each group will be calculated. This outcome will be measured on the dental casts 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 anteroposterior movement of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.

  Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase

• Change in the inter-canine width

  The change in the inter-canine width (mm/month) in each group will be calculated. Assessment will be performed by measuring the distance between the cusp tips of the two upper canines. This variable will be measured on dental casts.

  Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase

• Change in the inter-molar width at 5 months

  The change in the inter-molar width (mm/month) in each group will be calculated. Assessment will be performed by measuring the distance between the central groove of the two first maxillary molars. This variable will be measured on dental casts.

  Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase

Secondary Outcomes (1)

• Change in molar antero-posterior position

  Time 0:1 day before the beginning of the retraction phase (baseline). Time 1: after 1 month from the beginning. Time 2: after 2 months. Time 3: after 3 months. Time 4: after 4 months. Time 5: immediately after the end of the retraction phase

Study Arms (3)

Piezosurgery and low-level laser therapy

EXPERIMENTAL

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.

Procedure: Piezosurgery and GaALAs diode laser

Piezosurgery only

EXPERIMENTAL

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

Procedure: Piezosurgery

Traditional treatment without acceleration

ACTIVE COMPARATOR

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

Other: Fixed orthodontic appliance

Interventions

Piezosurgery and GaALAs diode laser 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 and low-level laser therapy

Piezosurgery 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.

Piezosurgery only

Fixed orthodontic appliance 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.

Traditional treatment without acceleration

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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
• The patient had previous orthodontic treatment

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (6)

• 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: 30559886 BACKGROUND

• 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.

  PMID: 32909702 BACKGROUND

• 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.

  PMID: 33378476 BACKGROUND

• 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.

  PMID: 34688577 BACKGROUND

• 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.

  PMID: 33158633 BACKGROUND

• 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.

  PMID: 40353446 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Piezosurgery; Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Mudar Mohammad Mousa, DDS

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y. Hajeer, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

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: November 20, 2022
• First Posted: December 19, 2022
• Study Start: October 9, 2019
• Primary Completion: January 12, 2021
• Study Completion: December 20, 2021
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)