Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement

Class II Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227859
• Other study ID #: UDDS-Ortho-01-2022
• Status: Completed
• Phase: N/A
• Start date: November 8, 2020
• Est. completion date: November 26, 2021

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 26, 2021
• Est. primary completion date: April 28, 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. Patient had previous orthodontic treatment

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Procedure:
• 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)

Device:
• Low-level laser
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.
• Conventional treatment
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.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View 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. — View Citation

Çagli 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. — View 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. — View Citation

Türker G, Yavuz I, Gönen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	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))
Secondary	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.	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)