Pain and Discomfort in Two Acceleration Methods of Canine Retraction

Comparison Between the Effect of Piezocision and Low-level Laser Therapy on Patient-centered Outcomes in Patients Undergoing Upper Canine Retraction

54 patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.

There are three groups:

The first group (control group): the canine retraction in this group will be performed in conventional method.

The second group (Experimental group): the canine retraction in this group will be performed in association with piezocision.

The third group (Experimental group): the canine retraction in this group will be performed in association with low-level laser therapy.

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion
• Intervention / Treatment: Procedure: Piezosurgery; Other: Low-level laser therapy; Device: Traditional treatment

Detailed Description

Closed nickel-titanium coil springs applying 150 g of force per side will be used for retraction of the upper canine.

Regarding the Piezocision, three vertical incisions will be made (3-mm depth and 8-10 mm length) after anesthesia. The cuts will be performed mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar.

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. After that, until the class I canine relationship will be achieved, the irradiation will be repeated every two weeks.

The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at five evaluation times during the first month of canine retraction.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • University of Damascus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 28 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piezosurgery; Piezocision will be applied in this group of patients using a piezosurgery knife.	Procedure: Piezosurgery; Three vertical incisions will be made (3-mm depth and 8-10 mm length) after anesthesia. The cuts will be performed mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar.
Experimental: Low-level laser therapy; Low-level laser therapy will be applied in this group of patients using a diode laser device.	Other: Low-level laser therapy; 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.
Active Comparator: Traditional treatment; No acceleration method will be performed in this group.	Device: Traditional treatment; The canine retraction in this group will be performed in conventional method. Closed nickel-titanium coil springs applying 150 g of force per side will be used for retraction of the upper canine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the levels of satisfaction	Assessment will be performed using questionnaires via Visual Analog scale and Two-point scale: (1) Yes (2) No.	T5: 28 days following the commencement of the retraction.
Change in the levels of pain	Assessment will be performed using questionnaires via Visual Analog scale.	T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Change in the levels of discomfort	Assessment will be performed using questionnaires via Visual Analog scale.	T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Change in the levels of swelling	Assessment will be performed using questionnaires via Visual Analog scale.	T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Levels of Eating difficulty	Assessment will be performed using questionnaires via Visual Analog scale.	T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the plaque index	Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess the status of oral hygiene in enrolled patients. A. (0) = No plaque. B. (1) = A film of plaque stuck to the free gingival margin and adjacent area of the tooth. C. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket. D. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket.	T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months
The change in the gingival index	Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess the status of the gingival tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar). A. (0) = Normal gingiva. B. (1) = Mild inflammation: minor change in color, slight oedema. No bleeding on probing. C. (2) = Moderate inflammation: redness, oedema and glazing and bleeding on probing. D. (3) = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding.	T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months
The change in the bleeding index	Assessment will be achieved using a gingival probe according to Muhlemann (1977) to assess the status of periodontal tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar). A. (0) = No bleeding. B. (1) = A single discreet bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears. D. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.	T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months
The change in the probing depth	Assessment will be achieved using a gingival probe according to Miller (1985) It will be measured clinically as the distance from the free gingival margin to the gingival sulcus around the maxillary laterals, canines, and 2nd premolars.	T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Doa'a Tahseen Alfailany, DDS, Department of orthodontics, Damascus University, Syria; Study Director: Mohammad Y Hajeer, DDS MSc PhD, Department of orthodontics, Damascus University, Syria

Publications and helpful links

General Publications

• Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
• 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.
• Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
• Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19.
• Keser E, Naini FB. Accelerated orthodontic tooth movement: surgical techniques and the regional acceleratory phenomenon. Maxillofac Plast Reconstr Surg. 2022 Jan 5;44(1):1. doi: 10.1186/s40902-021-00331-5.
• Farid KA, Eid AA, Kaddah MA, Elsharaby FA. The effect of combined corticotomy and low level laser therapy on the rate of orthodontic tooth movement: split mouth randomized clinical trial. Laser Ther. 2019 Dec 31;28(4):275-283. doi: 10.5978/islsm.19-OR-19.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2021
• Primary Completion (Actual): July 12, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pain; low-level laser; Diode laser; Piezosurgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: UDDS-Ortho-04-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No