An interventional study of Electric stimulation removable appliance and Traditional orthodontic fixed appliance without accleration in Class II Division 1 Malocclusion, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 17 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 40 is above the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Patients in this group will undergo conventional orthodontic treatment combined with electrical stimulation for the retraction of upper canines.
Device: Electric stimulation removable appliance
Patients in this group will receive conventional orthodontic treatment without any acceleration method.
Procedure: Traditional orthodontic fixed appliance without accleration
The device will be used with the fixed appliance to accelerate orthodontic tooth movement (i.e., canine retraction).
The traditional method of canine retraction will be employed using fixed appliances. No additional appliances will be used to activate orthodontic tooth movement.
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).
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.
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).
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.
Change in difficulty swallowing
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).
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.
Change in the chewing ability
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).
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.
Change in the speech ability
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).
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.
Change in analgesic consumption
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).
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.
Patients' satisfaction
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).
Time frame: Questionnaires will be filled at the end of the fourth month of the canine retraction
Recommendation of the procedure to a friend
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).
Time frame: Questionnaires will be filled at the end of the fourth month of the canine retraction
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Damascus University