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

Angle Class II Clinical Trial

Official title:

Effectiveness of Piezocision or the Combination of Piezocision and Low-level Laser Therapy on Orthodontic Tooth Movement During En-masse Retraction and the Associated Dentoalveolar Changes: A Three-arm Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05655169
• Other study ID #: UDDS-Ortho-14-2022
• Status: Completed
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: December 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 20, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Angle Class II
• Malocclusion, Angle Class II

Intervention

Procedure:
• 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.
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Syrian Arab Republic	University of Damascus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in molar antero-posterior position	The amount of distance being travelled by the first molars is going to be measured on study models taken at monthly intervals until the end of the retraction phase.	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	Amount of 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.	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