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

Primary Purpose

Tooth Migration

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hycon device(Routine protocol)
Hycon device(Modified protocol)
Hycon device(Routine protocol) and Vibration(Acceledent)
Hycon device(Modified protocol) and Vibration(Acceledent)
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Migration focused on measuring Vibration, Tooth movement acceleration

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Erciyes University, Faculty of Dentistry, Department of Orthodontics University university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Hycon device(Routine protocol)

Hycon device(Modified protocol)

Hycon device(Routine protocol) and Vibration

Hycon device(Modified protocol) and Vibration

Arm Description

The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions.

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.

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.

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.

Outcomes

Primary Outcome Measures

Acceleration of tooth movement
maxillary canine distal movement amount (mm)

Secondary Outcome Measures

Reduction of pain during treatment
measurement of pain level (grading system, VAS scoring)
Shortening of total treatment time
measurement of treatment time (months)

Full Information

First Posted
April 12, 2019
Last Updated
October 2, 2019
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT03968263
Brief Title
The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Canine Teeth Distalization
Acronym
Acceleration
Official Title
The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Orthodontic Canine Teeth Distalization
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
February 8, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Migration
Keywords
Vibration, Tooth movement acceleration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Routine orthodontic treatment procedures will be applied to patients
Masking
ParticipantOutcomes Assessor
Masking Description
It will not be possible to prevent clinicians and their interventions.
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hycon device(Routine protocol)
Arm Type
Active Comparator
Arm Description
The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions.
Arm Title
Hycon device(Modified protocol)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hycon device(Routine protocol) and Vibration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hycon device(Modified protocol) and Vibration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hycon device(Routine protocol)
Intervention Description
Hycon device will be activated half a turn every 3 days.
Intervention Type
Device
Intervention Name(s)
Hycon device(Modified protocol)
Intervention Description
The activation period of the hycon device will be modified.
Intervention Type
Device
Intervention Name(s)
Hycon device(Routine protocol) and Vibration(Acceledent)
Intervention Description
Hycon device will be activated half a turn every 3 days. Vibration will be applied 2 times 10 minutes per day.
Intervention Type
Device
Intervention Name(s)
Hycon device(Modified protocol) and Vibration(Acceledent)
Intervention Description
The activation period of the hycon device will be modified. Vibration will be applied 2 times 10 minutes per day.
Primary Outcome Measure Information:
Title
Acceleration of tooth movement
Description
maxillary canine distal movement amount (mm)
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Reduction of pain during treatment
Description
measurement of pain level (grading system, VAS scoring)
Time Frame
2 year
Title
Shortening of total treatment time
Description
measurement of treatment time (months)
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osman Yildiz, Research as.
Organizational Affiliation
Research as.
Official's Role
Study Chair
Facility Information:
Facility Name
Erciyes University, Faculty of Dentistry, Department of Orthodontics University university
City
Kayseri
State/Province
Melikgazi
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16247198
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. No abstract available.
Results Reference
background
PubMed Identifier
30923687
Citation
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.
Results Reference
background
Links:
URL
https://progressinorthodontics.springeropen.com/articles/10.1186/2196-1042-14-42
Description
pubmed ID not found

Learn more about this trial

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

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