The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Orthodontic Canine Teeth Distalization
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Acceleration of tooth movement
研究概览
简要总结
This study will be performed with 25 patients who applied to Erciyes University Faculty of Dentistry for treatment and who need 2 first premolar extraction and maximum anchorage for treatment. In order to increase anchorage in the patient who will start the distalization of canine, mini screw (1.5 mm diameter, 7 mm length) will be applied to the right and left maxillary dentition of the patient under local anesthesia. The hycon device, which has a screw-shaped design for the application of force to both the right and left sides of the maxillary dentition of the patients, will be adapted to the bands in the 1st molar teeth. Patients will be randomly divided into 4 groups. Vibration will be applied to the two groups with the Acceledent device.
Group 1 = The hycon device in this group will be used in accordance with the manufacturer's instructions.
Group 2 = The activation period of the hycon device in this group will be modified.
Group 3 = The hycon device in this group will be used in accordance with the manufacturer's instructions. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
Group 4 = The activation period of the hycon device in this group will be modified. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
The period of canine distalization of orthodontic treatment is one of the important stages affecting the duration of treatment. Shortening this time in the clinic will shorten the duration of treatment.
If this application changes the tooth movement speed in any direction, it will support the new research.
详细描述
This study is planned as a splint mouth, randomized, non-controlled clinical trial.This study will be performed with 25 patients who applied to Erciyes University Faculty of Dentistry for treatment and who need 2 first premolar extraction and maximum anchorage for treatment.Patients will be selected from 12 to 18 years of age.In order to increase anchorage in the patient who will start the distalization of canine, mini screw (PSM Medical Solutions, Quattro Standard Screw 1,5x7mm, Tuttlingen,Germany) will be applied to the right and left maxillary dentition of the patient under local anesthesia.The hycon device (Adenta,Germany), which has a screw-shaped design for the application of force to both the right and left sides of the maxillary dentition of the patients, will be adapted to the bands in the 1st molar teeth.The approval of the study was taken from Erciyes University Clinical Research Ethics Committee in Kayseri (2018/337).Informed consent will be obtained from all patients included in the study.Consent will be taken from parents of those under the age of 18. At the beginning of the treatment and at the end of the treatment, all patients who participated in the study received standard treatment records including photographs, dental models and radiography.
Inclusion criteria:
- No systemic disease
- Being healthy as periodontal.
- No smoking.
- No previous orthodontic treatment.
- Lack of congenital tooth deficiency
- Permanent dentition
- Indication of extraction for 1.premolar in the maxilla
- There is no restoration of upper canine teeth.
- Indication of the use of mini screw for maximum anchoring in the maxilla
All models will be scanned by 3D laser model scanning device (3 Shape, R 700 Desktop Scanner, Szczecin, Poland) and digitalized (3Shape Ortho Analyzer ™ 12). The gradient of the teeth and the amount of space closure will be examined by using panoramic radiographs. The amount of root resorption in canine teeth will be measured by using periapical radiography. As a result of the data obtained, the effects of the hycon device(Adenta, Germany) and vibration device(Acceledent Aura, OrthoAccel Technologies, Inc. USA) on the tooth movement speed will be compared.
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
- Double (Participant, Outcomes Assessor)
盲法说明
It will not be possible to prevent clinicians and their interventions.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No systemic disease
- •Being healthy as periodontal.
- •No smoking.
- •No previous orthodontic treatment.
- •Lack of congenital tooth deficiency
- •Permanent dentition
- •Indication of extraction for 1.premolar in the maxilla
- •There is no restoration of upper canine teeth.
- •Indication of the use of mini screw for maximum anchoring in the maxilla
排除标准
- •Orthodontic treatment history
- •Missing tooth
- •Poor oral hygiene
- •Lack of cooperation
研究组 & 干预措施
Hycon device(Routine protocol) and Vibration
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Routine protocol) (Device)
Hycon device(Routine protocol)
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions.
干预措施: Hycon device(Routine protocol) (Device)
Hycon device(Routine protocol)
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions.
干预措施: Hycon device(Modified protocol) (Device)
Hycon device(Routine protocol)
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions.
干预措施: Hycon device(Routine protocol) and Vibration(Acceledent) (Device)
Hycon device(Routine protocol)
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions.
干预措施: Hycon device(Modified protocol) and Vibration(Acceledent) (Device)
Hycon device(Modified protocol)
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise.
干预措施: Hycon device(Routine protocol) (Device)
Hycon device(Modified protocol)
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise.
干预措施: Hycon device(Modified protocol) (Device)
Hycon device(Modified protocol)
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise.
干预措施: Hycon device(Routine protocol) and Vibration(Acceledent) (Device)
Hycon device(Modified protocol)
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise.
干预措施: Hycon device(Modified protocol) and Vibration(Acceledent) (Device)
Hycon device(Routine protocol) and Vibration
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Modified protocol) (Device)
Hycon device(Routine protocol) and Vibration
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Routine protocol) and Vibration(Acceledent) (Device)
Hycon device(Routine protocol) and Vibration
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Modified protocol) and Vibration(Acceledent) (Device)
Hycon device(Modified protocol) and Vibration
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Routine protocol) (Device)
Hycon device(Modified protocol) and Vibration
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Modified protocol) (Device)
Hycon device(Modified protocol) and Vibration
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Routine protocol) and Vibration(Acceledent) (Device)
Hycon device(Modified protocol) and Vibration
The activation period of the hycon device in this group will be modified. The first day will be clockwise half a turn, the second day will be half-turn clockwise and the third day will be turned half a turn counterclockwise. In addition, patients in this group twice a day for 10 minutes with acceledent device vibration will be applied.
干预措施: Hycon device(Modified protocol) and Vibration(Acceledent) (Device)
结局指标
主要结局
Acceleration of tooth movement
时间窗: 2 year
maxillary canine distal movement amount (mm)
次要结局
- Reduction of pain during treatment(2 year)
- Shortening of total treatment time(2 year)
研究者
Ahmet Yağcı
Associate Professor
TC Erciyes University