Assessment of the Effects of Piezocision and Low-level Laser Therapy on Orthodontic Tooth Movement During Canine Retraction and the Associated Dentoalveolar Changes: A Three-arm Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of upper canine retraction
研究概览
简要总结
Sixty patients requiring extraction-based treatment of the maxillary first premolars, followed by retraction of the maxillary canines, will be randomly assigned to three groups: piezocision, low-level laser therapy, and control. In each group, canine retraction will be initiated after completion of the leveling and alignment phase, using closed nickel-titanium coil springs that apply 150 g of force per side. For anchorage, a soldered transpalatal arch will be used.
Pre- and post-distalization dental casts will be assessed to evaluate the rate of canine retraction, canine rotation, and anchorage loss over the follow-up period until a Class I canine relationship is achieved. Periodontal health will be assessed before and after canine retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, and probing depth.
详细描述
Before enrollment of each subject in the study, they will undergo a comprehensive assessment to ensure their eligibility. The operator will inform them of the study's aim and request written informed consent.
At the end of the leveling and alignment stage, the upper first premolars will be extracted. The rectangular stainless steel archwires (0.019" × 0.025") will be inserted, and after one month, canine retraction will be initiated.
Regarding the Piezocision, after anesthesia, three vertical incisions will be made (3-mm depth and 8-10 mm length) mesial and distal to the upper canine, as well as at an equal distance from the upper canine and the 2nd premolar. The surgical procedures will be repeated after six weeks (only the mesial and distal canine incisions will be done) Regarding low-level laser therapy (LLLT), a GaAlAs diode laser (wavelength: 810 nm; exposure time: 10 seconds per point) will be applied around the upper canine at 10 sites, buccally and palatally. The central portion of the extraction site will also be irradiated at four sites (2 buccally and two palatally). LLLT will be applied 5 times during the first month of canine retraction, then every 2 weeks until a Class I canine relationship is achieved.
The upper canine destalization will be done using NiTi springs. The force level will be controlled every 2 weeks. Retraction will be stopped when a class I canine relationship is present on both sides.
Dental casts will be used to quantify the anteroposterior movement of the upper canines and first molars at 30-day intervals until the Class I canine relationship is achieved.
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
Duration of upper canine retraction
时间窗: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to occur within four months in the experimental groups and seven months in the control group
Assessment will be performed by calculating the months required to achieve complete retraction of the upper canine retraction through clinical examination.
Rate of retraction
时间窗: Time Frame: The calculation of the rate of retraction will be done once the retraction procedures have finished. Completion of this procedure is expected to occur within 4 months in the experimental groups and 7 months in the control group.
Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.
次要结局
- Change in Molars' positions(T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months; and T4: at the end of retraction (expected to be within 4 months to 7 months)))
- Change in canine' rotation(T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months of retraction; and T4: at the end of retraction (expected to be within 4 months to 7 months))
- Change in the plaque index(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)
- Change in the gingival index(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)
- Change in the papillary bleeding index(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)
- Change in the probing depth(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)
- Change in Molars' positions(T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months; and T4: at the end of retraction (expected to be within 4 months to 7 months)))
- Change in canine' rotation(T0: 1 day before the beginning of canine retraction; T1: after 1 month of retraction; T2: after 2 months of retraction; T3: after 3 months of retraction; and T4: at the end of retraction (expected to be within 4 months to 7 months))
- Change in the plaque index(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)
- Change in the gingival index(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)
- Change in the papillary bleeding index(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)
- Change in the probing depth(T0: immediately before the commencement of the retraction phase; T1: at the end of the retraction phase, which is expected to occur within 4 months in the experimental groups and 7 months in the control group)