Patient-related Outcomes When Accelerating Upper Canine Retraction With Fixed Orthodontic Appliances
Patient-reported Outcomes of Accelerated Upper Canine Retraction With Low-amperage Electrical Stimulation: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Detailed Description
Maxillary canine retraction can be lengthy, and various methods have been employed to accelerate it. Electrical current stimulation has shown promise as a technique for speeding up tooth movement. However, only a limited number of studies have been documented in the literature. Controlled clinical studies are necessary to evaluate the effectiveness of this procedure in accelerating tooth movement, its impact on pain responses, and other patient-centred outcomes.
Participants will be selected from patients attending the Orthodontics Department at the Faculty of Dentistry, Damascus University. Eligible patients with Class II/Division I malocclusion who meet the inclusion criteria will be invited to participate in this trial after being screened by the researcher. Informed consent will be obtained from all patients who agree to join the study after receiving an information sheet.
Alignment and leveling will be performed using pre-adjusted fixed orthodontic appliances consisting of 0.022 x 0.028-inch metal brackets with the MBT prescription. The traditional wiring sequence will be followed until a 0.019 x 0.025-inch stainless steel base wire is in place.
Maxillary first premolars will be extracted during the leveling and alignment phase, with more than two months between the completion of the alignment phase and the extraction. This ensures that the phenomenon of regional acceleration generated by the extraction does not affect the rate of tooth movement.
Canine retraction will be achieved using closed-coil nickel-titanium (NiTi) springs extending from the upper first molar band hook to the canine bracket hook. A force of 150 grams will be applied to each side, and the force will be checked using a force meter at each appointment (every two weeks) until the canine retraction is complete, achieving a Class I canine relationship.
A small electrical current will be applied to the upper maxillary canine area using a removable intraoral appliance containing a micro electrical circuit. Each patient in the experimental group will be asked to wear the electrical accelerator in their mouth for 5 hours daily.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Damascus, Syrian Arab Republic, DM20AM19
- Department of Orthodontics, Faculty of Dentistry, University of Damascus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Electrical Stimulation Group
Patients in this group will undergo conventional orthodontic treatment combined with electrical stimulation for the retraction of upper canines.
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The device will be used with the fixed appliance to accelerate orthodontic tooth movement (i.e., canine retraction).
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Active Comparator: Conventional Traction Group
Patients in this group will receive conventional orthodontic treatment without any acceleration method.
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The traditional method of canine retraction will be employed using fixed appliances.
No additional appliances will be used to activate orthodontic tooth movement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the perception of pain
Time Frame: 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.
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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).
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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.
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Change in the perception of discomfort
Time Frame: 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.
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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).
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in difficulty swallowing
Time Frame: 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.
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Patients will be asked to rate their perception of difficulty swallowing with the question, "What is the degree of difficulty swallowing you are experiencing at this moment?"
They will indicate their level of difficulty swallowing by placing a mark on a horizontal 100-mm line.
The left end of the line represents no difficulty swallowing (VAS=0), while the right end signifies maximum difficulty swallowing (VAS=100).
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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.
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Change in the chewing ability
Time Frame: 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.
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Patients will be asked to rate their perception of chewing ability with the question, "What is the degree of difficulty you are experiencing in chewing?"
They will indicate their level of chewing difficulty by placing a mark on a horizontal 100-mm line.
The left end of the line represents no difficulty (VAS=0), while the right end signifies maximum difficulty in mastication (VAS=100).
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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.
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Change in the speech ability
Time Frame: 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.
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Patients will be asked to rate their perception of speech ability with the question, "What is the degree of difficulty you are experiencing in speech?"
They will indicate their level of speech difficulty by placing a mark on a horizontal 100-mm line.
The left end of the line represents no difficulty (VAS=0), while the right end signifies maximum difficulty (VAS=100).
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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.
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Change in analgesic consumption
Time Frame: 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.
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Patients will be asked the following question about "Analgesic Consumption": "Did you need to take pain analgesics?" Analgesic consumption is assessed by inquiring if the study participant took analgesics, using a two-point scale (1.
Yes or 2. No).
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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.
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Patients' satisfaction
Time Frame: Questionnaires will be filled at the end of the fourth month of the canine retraction
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Patients will be asked to evaluate their satisfaction with orthodontic treatment with the question, "How satisfied are you with your orthodontic treatment?"
Satisfaction for both groups will be assessed by having the study participant place a mark on a horizontal 100-mm line to indicate their level of satisfaction.
The left end of the line represents no satisfaction (VAS=0), while the right end signifies maximum satisfaction (VAS=100).
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Questionnaires will be filled at the end of the fourth month of the canine retraction
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Recommendation of the procedure to a friend
Time Frame: Questionnaires will be filled at the end of the fourth month of the canine retraction
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Patients will be asked the following question about the likelihood of recommending the procedure to their friends: "Would you recommend this treatment to a friend?"
Those in the experimental group will indicate their response using a two-point scale (1.
Yes, or 2. No).
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Questionnaires will be filled at the end of the fourth month of the canine retraction
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammad N. Kheshfeh, DDS, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
- Study Director: Mohammad Y. Hajeer, DDS MSc PhD, Department of Orthodontics, Faculty of Dentistry, Damascus University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-Ortho-4-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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