Pain and Discomfort in Two Acceleration Methods of Canine Retraction

Not Applicable

Completed

• Conditions: Class II Malocclusion
• Interventions: Procedure: Piezosurgery; Other: Low-level laser therapy; Device: Traditional treatment

• Registration Number: NCT05265416
• Lead Sponsor: Damascus University

Brief Summary

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.

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 Timeline

• Study Start: 2021-10-22
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Primary Completion: 2022-07-12
• Study Completion: 2022-11-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Piezosurgery	Piezosurgery	Piezocision will be applied in this group of patients using a piezosurgery knife.
Low-level laser therapy	Low-level laser therapy	Low-level laser therapy will be applied in this group of patients using a diode laser device.
Traditional treatment	Traditional treatment	No acceleration method will be performed in this group.

Primary Outcome Measures

Name	Time	Method
Levels of Eating difficulty	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.	Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of satisfaction	T5: 28 days following the commencement of the retraction.	Assessment will be performed using questionnaires via Visual Analog scale and Two-point scale: (1) Yes (2) No.
Change in the levels of discomfort	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.	Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of pain	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.	Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of swelling	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.	Assessment will be performed using questionnaires via Visual Analog scale.

Trial Locations

Locations (1)

University of Damascus; 🇸🇾 Damascus, Syrian Arab Republic