Pain and Discomfort in Two Acceleration Methods of Canine Retraction

NCT05265416 | Completed DMC

• 1 other identifier: UDDS-Ortho-04-2022
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Class II Malocclusion

Keywords

Piezosurgery; Diode laser; low-level laser; Pain

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

Study Arms (3)

Piezosurgery

EXPERIMENTAL

Piezocision will be applied in this group of patients using a piezosurgery knife.

Procedure: Piezosurgery

Low-level laser therapy

EXPERIMENTAL

Low-level laser therapy will be applied in this group of patients using a diode laser device.

Other: Low-level laser therapy

Traditional treatment

ACTIVE COMPARATOR

No acceleration method will be performed in this group.

Device: Traditional treatment

Interventions

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.

Piezosurgery

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.

Low-level laser therapy

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.

Traditional treatment

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 32909702 BACKGROUND

• 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.

  PMID: 24326120 BACKGROUND

• 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.

  PMID: 25989211 BACKGROUND

• 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.

  PMID: 34984554 BACKGROUND

• 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.

  PMID: 32255919 BACKGROUND

• 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.

  PMID: 30991984 BACKGROUND

MeSH Terms

Conditions

Overbite; Pain

Interventions

Piezosurgery; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Doa'a Tahseen Alfailany, DDS

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 3, 2022
• Study Start: October 22, 2021
• Primary Completion: July 12, 2022
• Study Completion: November 30, 2022
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)