The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Canine Teeth Distalization
Acceleration
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2019
CompletedFirst Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2021
CompletedOctober 4, 2019
October 1, 2019
1.2 years
April 12, 2019
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceleration of tooth movement
maxillary canine distal movement amount (mm)
2 year
Secondary Outcomes (2)
Reduction of pain during treatment
2 year
Shortening of total treatment time
2 year
Study Arms (4)
Hycon device(Routine protocol)
ACTIVE COMPARATORThe hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions.
Hycon device(Modified protocol)
ACTIVE COMPARATORThe 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.
Hycon device(Routine protocol) and Vibration
ACTIVE COMPARATORThe 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.
Hycon device(Modified protocol) and Vibration
ACTIVE COMPARATORThe 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.
Interventions
Hycon device will be activated half a turn every 3 days.
The activation period of the hycon device will be modified.
Hycon device will be activated half a turn every 3 days. Vibration will be applied 2 times 10 minutes per day.
The activation period of the hycon device will be modified. Vibration will be applied 2 times 10 minutes per day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Orthodontic treatment history
- Missing tooth
- Poor oral hygiene
- Lack of cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University, Faculty of Dentistry, Department of Orthodontics University university
Kayseri, Melikgazi, 38039, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 16247198BACKGROUNDElmotaleb 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.
PMID: 30923687BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Osman Yildiz, Research as.
Research as.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- It will not be possible to prevent clinicians and their interventions.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 12, 2019
First Posted
May 30, 2019
Study Start
February 8, 2019
Primary Completion
May 1, 2020
Study Completion
February 8, 2021
Last Updated
October 4, 2019
Record last verified: 2019-10