Clinical trial NCT06875037: Patient-related Outcomes When Accelerating Upper Canine Retraction With Fixed Orthodontic Appliances
Official title: Patient-reported Outcomes of Accelerated Upper Canine Retraction With Low-amperage Electrical Stimulation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Division 1 Malocclusion
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the perception of pain
timeFrame: 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.
measure: Change in the perception of discomfort
timeFrame: 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:
measure: Change in difficulty swallowing
timeFrame: 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.
measure: Change in the chewing ability
timeFrame: 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.
measure: Change in the speech ability
timeFrame: 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.
measure: Change in analgesic consumption
timeFrame: 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.
measure: Patients' satisfaction
timeFrame: Questionnaires will be filled at the end of the fourth month of the canine retraction
measure: Recommendation of the procedure to a friend
timeFrame: Questionnaires will be filled at the end of the fourth month of the canine retraction
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, Faculty of Dentistry, University of Damascus
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Mohammad N. Kheshfeh, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University
name: Mohammad Y. Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.