Tooth MigrationAccelerationNCT03968263
The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Canine Teeth Distalization
A study testing Hycon device(Routine protocol), Hycon device(Modified protocol) and Hycon device(Routine protocol) and Vibration(Acceledent) in people with Tooth Migration, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Migration
- What is being tested?
- Hycon device(Routine protocol), Hycon device(Modified protocol) and Hycon device(Routine protocol) and Vibration(Acceledent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2019to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No systemic disease
- Being healthy as periodontal.
- No smoking.
- No previous orthodontic treatment.
- Lack of congenital tooth deficiency
- Permanent dentition
Show all 9Show fewer
- 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
Who cannot join
- Orthodontic treatment history
- Missing tooth
- Poor oral hygiene
- Lack of cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University, Faculty of Dentistry, Department of Orthodontics University university
Kayseri, Melikgazi, 38039
About this study
Official title: The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Orthodontic Canine Teeth Distalization
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.
Read more
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.
Read the 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.
- Conditions
- Tooth Migration
- Being tested
- Hycon device(Routine protocol), Hycon device(Modified protocol), Hycon device(Routine protocol) and Vibration(Acceledent), Hycon device(Modified protocol) and Vibration(Acceledent)
- Keywords
- Vibration, Tooth movement acceleration
- Medical subject headings
- Tooth Migration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hycon device(Routine protocol)Device
Hycon device will be activated half a turn every 3 days.
Hycon device(Modified protocol)Device
The activation period of the hycon device will be modified.
Hycon device(Routine protocol) and Vibration(Acceledent)Device
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)Device
The activation period of the hycon device will be modified. Vibration will be applied 2 times 10 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Hycon device(Routine protocol) | Active comparator | The hycon device in this group will be activeted into half turn every 3 days in accordance with the manufacturer's instructions. Receives: Device: Hycon device(Routine protocol); Device: Hycon device(Modified protocol); Device: Hycon device(Routine protocol) and Vibration(Acceledent); Device: Hycon device(Modified protocol) and Vibration(Acceledent) |
| Hycon device(Modified protocol) | Active comparator | 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. Receives: Device: Hycon device(Routine protocol); Device: Hycon device(Modified protocol); Device: Hycon device(Routine protocol) and Vibration(Acceledent); Device: Hycon device(Modified protocol) and Vibration(Acceledent) |
| Hycon device(Routine protocol) and Vibration | Active comparator | 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. Receives: Device: Hycon device(Routine protocol); Device: Hycon device(Modified protocol); Device: Hycon device(Routine protocol) and Vibration(Acceledent); Device: Hycon device(Modified protocol) and Vibration(Acceledent) |
| Hycon device(Modified protocol) and Vibration | Active comparator | 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. Receives: Device: Hycon device(Routine protocol); Device: Hycon device(Modified protocol); Device: Hycon device(Routine protocol) and Vibration(Acceledent); Device: Hycon device(Modified protocol) and Vibration(Acceledent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceleration of tooth movement
maxillary canine distal movement amount (mm)
Measured: 2 year
Secondary outcomes (2)
Reduction of pain during treatment
measurement of pain level (grading system, VAS scoring)
Measured: 2 year
Shortening of total treatment time
measurement of treatment time (months)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start8 Feb 2019
- Primary completion1 May 2020 (estimated)
- Study completion8 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth MigrationStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Routine orthodontic treatment procedures will be applied to patients
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Yağcı, TC Erciyes University
- Investigators
- Osman Yildiz, Research as., Study chair, Research as.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968263
- Sponsor's protocol ID
- TDH-2019-8701
- Other IDs
- TDH-2019-8701
- Acronym
- Acceleration
- Status last verified
- Oct 2019
- First submitted
- 12 Apr 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16247198Elmotaleb 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.
PubMed 30923687
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Activation Protocols of Hycon Device and Vibration Stimulation on Orthodontic Canine Teeth Distalization
- ClinicalTrials.gov ID
- NCT03968263
- Acronym / sponsor ID
- Acceleration / TDH-2019-8701
- Conditions
- Tooth Migration
- Keywords
- Vibration, Tooth movement acceleration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 8 Feb 2021 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Routine orthodontic treatment procedures will be applied to patients
| Arm | Type | Receives |
|---|---|---|
| Hycon device(Routine protocol) | Active comparator | Device: Hycon device(Routine protocol), Device: Hycon device(Modified protocol), Device: Hycon device(Routine protocol) and Vibration(Acceledent), Device: Hycon device(Modified protocol) and Vibration(Acceledent)The 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 comparator | Device: Hycon device(Routine protocol), Device: Hycon device(Modified protocol), Device: Hycon device(Routine protocol) and Vibration(Acceledent), Device: Hycon device(Modified protocol) and Vibration(Acceledent)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. |
| Hycon device(Routine protocol) and Vibration | Active comparator | Device: Hycon device(Routine protocol), Device: Hycon device(Modified protocol), Device: Hycon device(Routine protocol) and Vibration(Acceledent), Device: Hycon device(Modified protocol) and Vibration(Acceledent)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. |
| Hycon device(Modified protocol) and Vibration | Active comparator | Device: Hycon device(Routine protocol), Device: Hycon device(Modified protocol), Device: Hycon device(Routine protocol) and Vibration(Acceledent), Device: Hycon device(Modified protocol) and Vibration(Acceledent)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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- No systemic disease
- Being healthy as periodontal.
- No smoking.
- No previous orthodontic treatment.
- Lack of congenital tooth deficiency
Key exclusion criteria (4 listed)
- Orthodontic treatment history
- Missing tooth
- Poor oral hygiene
- Lack of cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hycon device(Routine protocol)Hycon device will be activated half a turn every 3 days. | Device | Hycon device(Modified protocol), Hycon device(Modified protocol) and Vibration, Hycon device(Routine protocol), Hycon device(Routine protocol) and Vibration |
| Hycon device(Modified protocol)The activation period of the hycon device will be modified. | Device | Hycon device(Modified protocol), Hycon device(Modified protocol) and Vibration, Hycon device(Routine protocol), Hycon device(Routine protocol) and Vibration |
| 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. | Device | Hycon device(Modified protocol), Hycon device(Modified protocol) and Vibration, Hycon device(Routine protocol), Hycon device(Routine protocol) and Vibration |
| 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. | Device | Hycon device(Modified protocol), Hycon device(Modified protocol) and Vibration, Hycon device(Routine protocol), Hycon device(Routine protocol) and Vibration |
Primary outcome
Acceleration of tooth movement
Time frame: 2 year
maxillary canine distal movement amount (mm)
2 secondary outcomes
Reduction of pain during treatment
Time frame: 2 year
Shortening of total treatment time
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 16247198McLaughlin 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.
- Background: PubMed 30923687Elmotaleb 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.
- pubmed ID not foundLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osman Yildiz, Research as. study chair
Research as.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hycon device(Routine protocol), Hycon device(Modified protocol) and Hycon device(Routine protocol) and Vibration(Acceledent) in people with Tooth Migration, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceleration of tooth movement (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.