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Completed

NCT Number: NCT05265416

Pain and Discomfort in Two Acceleration Methods of 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.

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Key information

Conditions

Class II Malocclusion Malocclusion Malocclusion, Angle Class II Neurologic Manifestations Overbite Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

17 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Patient had previous orthodontic treatment

Treatment and study plan

Piezosurgery

Procedure

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.

Low-level laser therapy

Other

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.

Traditional treatment

Device

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.

Primary outcomes

  1. Change in the levels of pain

    Time frame: 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.

  2. Change in the levels of discomfort

    Time frame: 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.

  3. Change in the levels of swelling

    Time frame: 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.

  4. Levels of Eating difficulty

    Time frame: 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.

  5. Change in the levels of satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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