Class II MalocclusionNCT04887974
Canine Retraction With Temporary Anchorage Devices
A study testing canine retraction in people with Class II Malocclusion and Class III Malocclusion, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Various malocclusions require the extraction of the first premolars and retraction of the canines with the need for maximum anchorage. If the canines are pulled into the extraction space using the molar teeth for support, unwanted tooth movement occurs. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Class II Malocclusion, Class III Malocclusion, Crowding, Tooth
- What is being tested?
- canine retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2016to 14 Jan 2017
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult orthodontic patient
- Any malocclusion requiring the extraction of the first premolar and canine retraction
- Full permanent dentition with the exception of the wisdom teeth.
Who cannot join
- Any missing permanent tooth
- Previous orthodontic treatment
- Periodontal disease; pregnancy
- Systemic disease or medication that affects bone metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canine Retraction Using Power Arms and Temporary Anchorage Devices
Various malocclusions require the extraction of the first premolars and retraction of the canines with the need for maximum anchorage. If the canines are pulled into the extraction space using the molar teeth for support, unwanted tooth movement occurs. This study aims to evaluate the effect of temporary anchorage devices and power arms, which are auxiliary orthodontic appliances in reducing undesirable tooth movements.
Read the detailed description
In orthodontic patients who require overjet correction, increased facial convexity, or relief of severe crowding, dental extraction followed by canine retraction is indicated. In conventional orthodontic treatment, the molars are used for anchorage and reinforced with intra-oral or extra-oral appliances. Although effective, this produces unwanted side effects where the molars move mesially and rotate, taking up some of the extraction space. As the canines move into the extraction space they tip backward requiring further uprighting. Power arms are vertical metal extensions placed in the canine brackets. They direct the force to the center of resistance of the tooth to allow bodily movement and prevent canine tipping. Temporary anchorage devices (TADs) are minimally invasive, small screws, inserted in the jaw bones to act as anchorage units instead of the molars.
This study aims to evaluate the effect of the TADs and power arms on the efficiency of canine retraction including the rate of canine retraction and canine tipping as well as mesial molar drift and rotation.
The null hypothesis is that the use of the power arm and the TADs have no effect on the canine retraction rate.
This study is a single-arm, single-center study. Twenty quadrants in 10 adult patients will be selected from the Orthodontic Outpatient Clinic at the Future University in Egypt.
Orthodontic records will be collected including study models, intra- and extra-oral photographs and cone beam computed tomograms.
Molars will be banded and Roth 0.22" brackets will be bonded to the canine and second premolars. Power arms, 8mmin length, will be inserted in the vertical slots of the canine brackets.
The dental arches will be leveled and aligned using consecutive archwires. TADs will be inserted between the second premolars and first molars. The first premolars will then be extracted and canines will be retracted within a week. Canines will be retracted along 0.016" X 0.22" stainless steel archwires using 150 g of force applied by an elastomeric chain. The elastic chain will be replaced every 4 weeks.
After 6 months of canine retraction, the orthodontic records will be collected for comparison.
- Being tested
- canine retraction
- Medical subject headings
- Overbite, Malocclusion, Angle Class III, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canine retractionProcedure or surgery
Canine retraction using elastomeric chains activated every 4 weeks, using power arms to direct force through the center of resistance and TADs for direct anchorage.
| Study group | Role | What they receive |
|---|---|---|
| Canine retraction | Experimental | The canines will be retracted by extending short silver elastomeric chains between the power arms in the canine brackets and the TADs. The applied force will be checked and adjusted to 150 g. Receives: Procedure: canine retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canine retraction
Amount of canine movement in millimeters measured on digital models. . The change in the vertical distance from the canine cusp tip to a line connecting the medial points of the third palatal rugae
Measured: Baseline to 6 months
Molar mesial drift
Amount of molar movement in millimeters measured on digital models. The change in the vertical distance from the mesiobuccal cusp tip to a line connecting the medial points of the third palatal rugae
Measured: Baseline to 6 months
Secondary outcomes (2)
Canine tipping
The change in the angle between the canine long axis, from cusp tip to root apex, and the palatal plane (a plane passing through the incisive foramen and the anterior and posterior nasal spines); measued on the cone beam computed tomogram.
Measured: Baseline to 6 months
molar rotation
The change in the angle between the molar horizontal axis and frontal Plane on the cone beam computed tomogram, in the axial view.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start2 Apr 2016
- Primary completion14 Jan 2017
- Study completion14 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehya Mostafa, Future University in Egypt
- Investigators
- Yehya Mostafa, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887974
- Sponsor's protocol ID
- 20153110
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canine Retraction Using Power Arms and Temporary Anchorage Devices
- ClinicalTrials.gov ID
- NCT04887974
- Acronym / sponsor ID
- 20153110
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 2 Apr 2016 (actual)
- Primary completion
- 14 Jan 2017 (actual)
- Study completion
- 14 Jan 2017 (actual)
- First posted
- 14 May 2021 (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.
Various malocclusions require the extraction of the first premolars and retraction of the canines with the need for maximum anchorage. If the canines are pulled into the extraction space using the molar teeth for support, unwanted tooth movement occurs. This study aims to evaluate the effect of temporary anchorage devices and power arms, which are auxiliary orthodontic appliances in reducing undesirable tooth movements.
Detailed description
In orthodontic patients who require overjet correction, increased facial convexity, or relief of severe crowding, dental extraction followed by canine retraction is indicated. In conventional orthodontic treatment, the molars are used for anchorage and reinforced with intra-oral or extra-oral appliances. Although effective, this produces unwanted side effects where the molars move mesially and rotate, taking up some of the extraction space. As the canines move into the extraction space they tip backward requiring further uprighting. Power arms are vertical metal extensions placed in the canine brackets. They direct the force to the center of resistance of the tooth to allow bodily movement and prevent canine tipping. Temporary anchorage devices (TADs) are minimally invasive, small screws, inserted in the jaw bones to act as anchorage units instead of the molars.
This study aims to evaluate the effect of the TADs and power arms on the efficiency of canine retraction including the rate of canine retraction and canine tipping as well as mesial molar drift and rotation.
The null hypothesis is that the use of the power arm and the TADs have no effect on the canine retraction rate.
This study is a single-arm, single-center study. Twenty quadrants in 10 adult patients will be selected from the Orthodontic Outpatient Clinic at the Future University in Egypt.
Orthodontic records will be collected including study models, intra- and extra-oral photographs and cone beam computed tomograms.
Molars will be banded and Roth 0.22" brackets will be bonded to the canine and second premolars. Power arms, 8mmin length, will be inserted in the vertical slots of the canine brackets.
The dental arches will be leveled and aligned using consecutive archwires. TADs will be inserted between the second premolars and first molars. The first premolars will then be extracted and canines will be retracted within a week. Canines will be retracted along 0.016" X 0.22" stainless steel archwires using 150 g of force applied by an elastomeric chain. The elastic chain will be replaced every 4 weeks.
After 6 months of canine retraction, the orthodontic records will be collected for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canine retraction | Experimental | Procedure: canine retractionThe canines will be retracted by extending short silver elastomeric chains between the power arms in the canine brackets and the TADs. The applied force will be checked and adjusted to 150 g. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult orthodontic patient
- Any malocclusion requiring the extraction of the first premolar and canine retraction
- Full permanent dentition with the exception of the wisdom teeth.
Key exclusion criteria (4 listed)
- Any missing permanent tooth
- Previous orthodontic treatment
- Periodontal disease; pregnancy
- Systemic disease or medication that affects bone metabolism
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 |
|---|---|---|
| canine retractionCanine retraction using elastomeric chains activated every 4 weeks, using power arms to direct force through the center of resistance and TADs for direct anchorage. | Procedure or surgery | Canine retraction |
Primary outcome
Canine retraction
Time frame: Baseline to 6 months
Amount of canine movement in millimeters measured on digital models. . The change in the vertical distance from the canine cusp tip to a line connecting the medial points of the third palatal rugae
Molar mesial drift
Time frame: Baseline to 6 months
Amount of molar movement in millimeters measured on digital models. The change in the vertical distance from the mesiobuccal cusp tip to a line connecting the medial points of the third palatal rugae
2 secondary outcomes
Canine tipping
Time frame: Baseline to 6 months
molar rotation
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
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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.
Yehya Mostafa study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing canine retraction in people with Class II Malocclusion and Class III Malocclusion, run by Future University in Egypt at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 14 May 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Canine retraction (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2021.