Patient-related Outcomes When Accelerating Upper Canine Retraction With Fixed Orthodontic Appliances

NCT06875037 | Completed DMC

• 1 other identifier: UDDS-Ortho-4-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be screened in the Orthodontics Department of the Faculty of Dentistry, Damascus University, and those who meet the inclusion criteria will be included. Then, the initial diagnostic records (diagnostic plaster casts, intra- and extra-oral photographs, and radiographs) will be studied to ensure the selection criteria are accurately met. This study aims to compare two groups of patients with Class II malocclusion. Experimental Group: Patients in this group will undergo maxillary canine retraction using the traditional sliding technique with fixed appliances, supplemented by electrical current stimulation. Control Group: Patients in this group will undergo maxillary canine retraction using the traditional sliding technique with fixed appliances, without any acceleration method.

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (2)

• Change in the perception of pain

  Patients will be asked to rate their pain perception with the question, "What is the degree of pain you are experiencing at this moment?" They will indicate their pain level by placing a mark on a horizontal 100-mm line. The left end of the line represents no pain (VAS=0), and the right end signifies maximum (unimaginable) pain (VAS=100).

  Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

• Change in the perception of discomfort

  Patients will be asked to rate their perception of discomfort with the question, "What is the degree of discomfort you are experiencing at this moment?" They will indicate their level of discomfort by placing a mark on a horizontal 100-mm line. The left end of the line represents no discomfort (VAS=0), while the right end signifies maximum (unimaginable) discomfort (VAS=100).

  Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

Secondary Outcomes (6)

• Change in difficulty swallowing

  Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

• Change in the chewing ability

  Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

• Change in the speech ability

  Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

• Change in analgesic consumption

  Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

• Patients' satisfaction

  Questionnaires will be filled at the end of the fourth month of the canine retraction

Study Arms (2)

Electrical Stimulation Group

EXPERIMENTAL

Patients in this group will undergo conventional orthodontic treatment combined with electrical stimulation for the retraction of upper canines.

Device: Electric stimulation removable appliance

Conventional Traction Group

ACTIVE COMPARATOR

Patients in this group will receive conventional orthodontic treatment without any acceleration method.

Procedure: Traditional orthodontic fixed appliance without accleration

Interventions

Electric stimulation removable appliance DEVICE

The device will be used with the fixed appliance to accelerate orthodontic tooth movement (i.e., canine retraction).

Electrical Stimulation Group

Traditional orthodontic fixed appliance without accleration PROCEDURE

The traditional method of canine retraction will be employed using fixed appliances. No additional appliances will be used to activate orthodontic tooth movement.

Conventional Traction Group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adults aged 17 to 28 years.
• Class II Division 1 malocclusion (according to Angle's classification) requires the extraction of the upper first premolar as part of the orthodontic treatment plan.
• Mild to moderate skeletal Class II (ANB = 5-7).
• Overjet of 5 to 10 mm.
• Normal or vertical growth patterns (MM ≥ 26; SN-MP ≥ 33; Y Axis ≥ 65)

You may not qualify if:

• Moderate to severe dental crowding.
• Missing teeth in the upper arch.
• Previous orthodontic treatment.
• Health conditions or long-term medication.
• Periodontal disease.
• Poor oral hygiene.
• Smoking

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, DM20AM19, Syria

Location

Related Publications (6)

• Mousa MM, Hajeer MY, Burhan AS, Darwich KMA, Almahdi WH, Aljabban O, Awawdeh MA, Almasri IA. Patient-Reported Outcome Measures of Flapless Corticotomy with Low-Level Laser Therapy in En Masse Retraction of Upper Anterior Teeth: A Three-Arm Randomized Controlled Trial. Clin Pract. 2023 Nov 22;13(6):1501-1519. doi: 10.3390/clinpract13060132.

  PMID: 38131681 BACKGROUND

• Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038.

  PMID: 35796046 BACKGROUND

• Shaadouh RI, Hajeer MY, Mahmoud GA, Almasri IA, Jaber ST, Alam MK. Patient-reported outcomes during accelerating the en-masse retraction of the upper anterior teeth using low-intensity electrical stimulation: a randomized controlled trial. Prog Orthod. 2024 May 13;25(1):17. doi: 10.1186/s40510-024-00517-3.

  PMID: 38735912 BACKGROUND

• Alfailany DT, Hajeer MY, Awawdeh MA, Khursheed Alam M, Darwich KMA, Aljabban O, Latifeh Y, Alhaffar JB, Almasri IA. Evaluation of Patient-Reported Outcome Measures (PROMs) Associated With the Acceleration of Canine Retraction by Piezosurgery in Comparison With Low-Level Laser Therapy: A Three-Arm Randomized Controlled Clinical Trial. Cureus. 2024 Jan 7;16(1):e51779. doi: 10.7759/cureus.51779. eCollection 2024 Jan.

  PMID: 38192530 BACKGROUND

• Charavet C, Lecloux G, Jackers N, Maes N, Lambert F. Patient-reported outcomes measures (PROMs) following a piezocision-assisted versus conventional orthodontic treatments: a randomized controlled trial in adults. Clin Oral Investig. 2019 Dec;23(12):4355-4363. doi: 10.1007/s00784-019-02887-z. Epub 2019 Apr 6.

  PMID: 30955096 BACKGROUND

• Kheshfeh MN, Hajeer MY, Alam MK, Al Hinnawi MF, Latifeh Y. Patient-reported outcome measures of accelerated upper canine retraction with low-amperage electrical stimulation: A randomized controlled trial. Int Orthod. 2025 Oct 3;24(1):101077. doi: 10.1016/j.ortho.2025.101077. Online ahead of print.

  PMID: 41045595 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohammad N. Kheshfeh, DDS

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y. Hajeer, DDS MSc PhD

  Department of Orthodontics, Faculty of Dentistry, Damascus University

  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: March 8, 2025
• First Posted: March 13, 2025
• Study Start: May 1, 2023
• Primary Completion: April 6, 2024
• Study Completion: December 1, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)