The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Canine Teeth Distalization

Tooth Migration Clinical Trial

— Acceleration  

Official title:

The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Orthodontic Canine Teeth Distalization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03968263
• Other study ID #: TDH-2019-8701
• Secondary ID: TDH-2019-8701
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: February 8, 2021

Study information

• Verified date: October 2019
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: February 8, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Exclusion Criteria:

• Orthodontic treatment history

• Missing tooth

• Poor oral hygiene

• Lack of cooperation

Related Conditions & MeSH terms

• Tooth Migration

Intervention

Device:
• Hycon device(Routine protocol)
Hycon device will be activated half a turn every 3 days.
• Hycon device(Modified protocol)
The activation period of the hycon device will be modified.
• Hycon device(Routine protocol) and Vibration(Acceledent)
Hycon device will be activated half a turn every 3 days. Vibration will be applied 2 times 10 minutes per day.
• Hycon device(Modified protocol) and Vibration(Acceledent)
The activation period of the hycon device will be modified. Vibration will be applied 2 times 10 minutes per day.

Locations

Country	Name	City	State
Turkey	Erciyes University, Faculty of Dentistry, Department of Orthodontics University university	Kayseri	Melikgazi

Sponsors (2)

Lead Sponsor	Collaborator
TC Erciyes University	Erciyes University, Department of Scientific Research Projects

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Elmotaleb MAA, Elnamrawy MM, Sharaby F, Elbeialy AR, ElDakroury A. Effectiveness of using a Vibrating Device in Accelerating Orthodontic Tooth Movement: A Systematic Review and Meta-Analysis. J Int Soc Prev Community Dent. 2019 Jan-Feb;9(1):5-12. doi: 10.4103/jispcd.JISPCD_311_18. Epub 2019 Feb 14. Review. — View Citation

McLaughlin RP, Kalha AS, Schuetz W. An alternative method of space closure: the Hycon Device. J Clin Orthod. 2005 Aug;39(8):474-84; quiz 471. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceleration of tooth movement	maxillary canine distal movement amount (mm)	2 year
Secondary	Reduction of pain during treatment	measurement of pain level (grading system, VAS scoring)	2 year
Secondary	Shortening of total treatment time	measurement of treatment time (months)	2 year

External Links

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