Comparison Between the Effect of Piezocision and Low-level Laser Therapy on Patient-centered Outcomes in Patients Undergoing Upper Canine Retraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Levels of Eating difficulty
研究概览
简要总结
54 patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.
There are three groups:
The first group (control group): the canine retraction in this group will be performed in conventional method.
The second group (Experimental group): the canine retraction in this group will be performed in association with piezocision.
The third group (Experimental group): the canine retraction in this group will be performed in association with low-level laser therapy.
详细描述
Closed nickel-titanium coil springs applying 150 g of force per side will be used for retraction of the upper canine.
Regarding the Piezocision, three vertical incisions will be made (3-mm depth and 8-10 mm length) after anesthesia. The cuts will be performed mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar.
Regarding the low-level laser therapy (LLLT): GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction. After that, until the class I canine relationship will be achieved, the irradiation will be repeated every two weeks.
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at five evaluation times during the first month of canine retraction.
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 28 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult healthy patients, Male and female, Age range: 17-28 years.
- •Class II Division 1 malocclusion :
- •Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7)
- •Overjet ≤10
- •Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
- •Mild to moderate crowding ≤ 4
- •Permanent occlusion.
- •Existence of all the upper teeth (except third molars).
- •Good oral and periodontal health:
- •Probing depth < 4 mm
- •No radiographic evidence of bone loss.
- •Gingival index ≤ 1
- •Plaque index ≤ 1
排除标准
- •Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), ...)
- •Presence of primary teeth in the maxillary arch
- •Missing permanent maxillary teeth (except third molars).
- •Poor oral hygiene or Current periodontal disease:
- •Probing depth ≥ 4 mm
- •radiographic evidence of bone loss
- •Gingival index > 1
- •Plaque index > 1
- •Patient had previous orthodontic treatment
结局指标
主要结局
Levels of Eating difficulty
时间窗: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of satisfaction
时间窗: T5: 28 days following the commencement of the retraction.
Assessment will be performed using questionnaires via Visual Analog scale and Two-point scale: (1) Yes (2) No.
Change in the levels of pain
时间窗: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of discomfort
时间窗: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of swelling
时间窗: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Assessment will be performed using questionnaires via Visual Analog scale.
次要结局
未报告次要终点