Patient-reported Outcomes of Accelerated Upper Canine Retraction With Low-amperage Electrical Stimulation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the perception of pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Electrical Stimulation Group
Patients in this group will undergo conventional orthodontic treatment combined with electrical stimulation for the retraction of upper canines.
干预措施: Electric stimulation removable appliance (Device)
Conventional Traction Group
Patients in this group will receive conventional orthodontic treatment without any acceleration method.
干预措施: Traditional orthodontic fixed appliance without accleration (Procedure)
结局指标
主要结局
Change in the perception of pain
时间窗: 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 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).
Change in the perception of discomfort
时间窗: 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 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).
次要结局
- 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)
- Recommendation of the procedure to a friend(Questionnaires will be filled at the end of the fourth month of the canine retraction)