Evaluation of Low-Level Laser Therapy (LLLT) and Flapless Corticopuncture Effect on Accelerating Implant-Supported En-Masse Retraction of the Six Maxillary Anterior Teeth (Clinical Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Duration of en-masse retraction of the six maxillary anterior teeth
研究概览
简要总结
The long time needed for orthodontic treatment is considered one of the biggest obstacles that make patients refuse to undergo orthodontic treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. Therefore, the purpose of this study is to evaluate the efficiency of two new noninvasive methods (Low-Level Laser Therapy and Corticopuncture) in accelerating orthodontic tooth movement for the implant supported En-Masse retraction of the six maxillary anterior teeth.
详细描述
This study will be a randomized controlled trial with a 1:1:1 allocation ratio. Sample size was calculated using Minitab version 15. 36 Participants recruited from patients attending the Department of Orthodontics and Dentofacial Orthopedics at Damascus University with class II division 1 malocclusion that indicates the extraction of first maxillary premolars will be randomly assigned into one of three groups: Low-Level Laser Therapy (LLLT) group, flapless corticopuncture group, or control group. Titanium mini-implants (1.6 mm diameter and 7 mm length) will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm height above the archwires below the mucogingival junction. After complete leveling and alignment of the maxillary dental arch, which will be defined by passive insertion of 19*25 inch S.S. archwire, the retraction stage of the six maxillary anterior teeth will begin.
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
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age between (18 - 24) years.
- •Class II Division 1 malocclusion that indicates extraction of two maxillary first premolars with the following parameters:
- •ANB: 5 to 10 degrees. Overjet: 5 to 10 mm. Growth Pattern: normal or slightly vertical.
- •All upper teeth are existed (Except for third molars).
- •Mild to moderate crowding (3 mm or less).
- •Patient dose not undergo any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, ...).
- •Good oral hygiene (Plaque index < 1).
排除标准
- •Any medical condition affecting orthodontic tooth movement.
- •Poor oral hygiene (Plaque index > 1).
- •Patient did not undergo previous orthodontic treatment.
- •Patient lack of commitment toward follow-up appointments.
研究组 & 干预措施
Low-Level Laser Therapy (LLLT)
In the LLLT group, a low-level laser with wavelength of 808 nm, output of 250 mW, energy of 4 Joules per point and application time of 16 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol: the root will be divided theoretically into 2 halves; gingival and cervical, and laser will be applied in the center of each half from both buccal and palatal sides which means 4 application points and a total energy of 16 Joules per tooth.
干预措施: Low-Level Laser Therapy (LLLT) (Radiation)
Flapless Corticopuncture
In the flapless corticopuncture group, 3 interdental punctures located between the roots of the six maxillary anterior teeth from both the buccal and palatal sides, will be done using a 1-mm diameter round surgical Tungsten bur with 1 mm depth and 1.5 mm space between each puncture. These punctures start 2 mm from the free gingiva. Besides, an additional 2 parallel set of punctures with the same dimensions of the interdental ones will be done in the extraction sockets from both the buccal and palatal sides.
干预措施: Flapless Corticopunture (Procedure)
Control
Patients in control group will undergo typical orthodontic treatment only with no LLLT or flapless corticopuncture application.
干预措施: Control (Other)
结局指标
主要结局
Duration of en-masse retraction of the six maxillary anterior teeth
时间窗: The months required to complete the retraction procedure will be recorded, which is expected to be occur within four months
Assessment will be performed by calculating the time required from the beginning of the six maxillary anterior teeth retraction till the completion of this procedure
Rate of en-masse retraction of the six maxillary anterior teeth
时间窗: The calculation of the rate of retraction will be done once the retraction procedure has finished which is expected to occur within four months
Assessment will be performed on study models by dividing the distance that the six maxillary anterior teeth moved during retraction to the time required to retract them to their ideal positions.
次要结局
- Maxillary first molar anchorage loss(This outcome will be measured one day before upper incisors' retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months)
- Root resorption(A CBCT image will be taken one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months)
- Changes in the gingival indices(This outcome will be measured one day before the six maxillary incisors retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months)
- Change in tooth vitality (the response of the pulp tissue toward external stimuli)(This outcome will be measured one day before the six maxillary anterior teeth retraction initiation (T0) and immediately after the completion of retraction (T1) which is expected to occur in 4 months)
- Changes in the levels of pain and discomfort(These levels will be assessed at: one day, one week, two weeks, and four weeks following the intervention)
- Change in the Oral Health Related Quality of Life associated with anterior teeth retraction.(The OHIP-14 will be assessed immediately after application, after 1, 7, 14, and 28 days of the six maxillary anterior teeth retraction initiation)