Malocclusion, Angle Class IIPGWCanineNCT07845227
Palatal Guide Wire for Canine Control During Miniscrew-Supported Distalization
A study testing Palatal guide wire and Miniscrew-supported canine distalization in people with Malocclusion, Angle Class II and Tooth Movement Techniques, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
When crowded or protruded teeth are treated by removing an upper premolar on each side, the canine (eye tooth) is first moved backward into the space. As it moves, the tooth tends to rotate and tip out of position, and this rotation is one of the hardest movements to correct and most likely to come back later. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Malocclusion, Angle Class II, Tooth Movement Techniques
- What is being tested?
- Palatal guide wire and Miniscrew-supported canine distalization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 16 Aug 2024
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Angle Class II division 1 or division 2 malocclusion
- Indication for maxillary first premolar extraction
- Maximum anchorage requirement
- Minimal or no maxillary incisor crowding
- No previous orthodontic treatment
- No congenitally missing or previously extracted maxillary teeth other than third molars
- Completed pubertal growth spurt
Who cannot join
- Any systemic disease or regular medication use
- Poor oral hygiene or active periodontal disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Faculty of Dentistry, Department of Orthodontics
Samsun, Marmara, 55139
About this study
Official title: Effect of a Palatal Guide Wire on Maxillary Canine Displacement During Miniscrew-Supported Distalization: A Split-Mouth Randomized Controlled Trial
When crowded or protruded teeth are treated by removing an upper premolar on each side, the canine (eye tooth) is first moved backward into the space. As it moves, the tooth tends to rotate and tip out of position, and this rotation is one of the hardest movements to correct and most likely to come back later. This study tested a simple addition to the usual treatment: a small passive wire attached to the inner (palate) side of the canine and connected to the back tooth, meant to guide the canine and keep it from rotating, without adding any extra force.
Sixteen adolescents who needed an upper premolar removed on both sides took part. Because each person has two sides, every patient received both approaches at once: on one randomly chosen side the guide wire was added, and the other side was treated the same way but without it, serving as that patient's own comparison. This split-mouth design lets each patient act as their own control.
The canine was moved backward on both sides using the same light spring and a small bone screw for anchorage. The researchers took dental scans at the start and after one, two, and three months and measured how far each canine moved, how much it rotated and tipped, and whether the back tooth drifted forward. The goal was to find out whether the guide wire reduces unwanted rotation and tipping and affects how quickly the canine moves, without weakening the anchorage.
Read the detailed description
This was a prospective, single-center, split-mouth randomized controlled trial conducted in the Department of Orthodontics, Faculty of Dentistry, Ondokuz Mayıs University. Sixteen patients (12 female, 4 male; mean age 16.6 ± 1.7 years) with Angle Class II division 1 or 2 malocclusion requiring bilateral maxillary first premolar extraction with maximum anchorage were enrolled.
In each patient, the side to receive the guide wire was randomly allocated, balanced so that the guide wire was placed on the right side in 8 patients and on the left in 8. Both canines were distalized with a 150-g nickel-titanium closed coil spring extended from an interradicular miniscrew to a U-shaped power arm seated in the vertical slot of the canine bracket. On the experimental side only, a passive 0.020-inch round stainless steel wire was engaged between a bracket bonded to the palatal surface of the canine and the first molar band sheath; this wire was never activated and added no force to the system.
Alginate impressions were taken at the start of distalization (T0) and after 1 (T1), 2 (T2), and 3 (T3) months. Casts were scanned and superimposed on the medial and lateral limits of the third palatal ruga and the medial limit of the second. Distopalatal rotation, canine distalization, canine tipping, and first molar anchorage loss were measured and compared between the guide wire and control sides using paired statistics on the within-patient difference.
- Being tested
- Palatal guide wire, Miniscrew-supported canine distalization
- Keywords
- Canine distalization, Palatal guide wire, Miniscrew, Distopalatal rotation, Anchorage, Split-mouth
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal guide wireDevice
A passive 0.020-inch round stainless steel wire engaged between a bracket bonded to the palatal surface of the maxillary canine and the first molar band sheath. The wire was never activated and added no force to the distalization system.
Miniscrew-supported canine distalizationProcedure or surgery
Distalization of the maxillary canine with a 150-g nickel-titanium closed coil spring extended from an interradicular miniscrew to a U-shaped power arm seated in the vertical slot of the canine bracket.
| Study group | Role | What they receive |
|---|---|---|
| Guide wire side | Experimental | The maxillary canine on the randomly allocated side was distalized with a 150-g nickel-titanium closed coil spring from an interradicular miniscrew to a power arm in the vertical slot of the canine bracket, with a passive palatal guide wire engaged between a bracket on the palatal surface of the canine and the first molar band sheath. Receives: Device: Palatal guide wire; Procedure: Miniscrew-supported canine distalization |
| Control side | Active comparator | The contralateral canine was distalized with the identical coil-spring and power-arm system, without a palatal guide wire. Receives: Procedure: Miniscrew-supported canine distalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative distopalatal rotation of the maxillary canine
Change from baseline in the angle between the sagittal reference line and a line through the canine cusp tip along the palatal ridge, measured on rugae-superimposed digital models and compared between the guide wire and control sides.
Measured: Baseline (T0) and 3 months (T3)
Cumulative canine distalization
Change from baseline in the perpendicular distance from the canine cusp tip to the sagittal reference line, compared between the guide wire and control sides.
Measured: Baseline (T0) and 3 months (T3)
Secondary outcomes (3)
Canine tipping
Change from baseline in the disto-occlusal angle of the canine relative to the horizontal reference, compared between sides.
Measured: Baseline (T0) and 3 months (T3)
First molar anchorage loss
Mesial movement of the maxillary first molar, measured from its mesial contact point to the sagittal reference line, compared between sides.
Measured: Baseline (T0) and 3 months (T3)
Monthly rate of canine distalization and rotation
Distalization and rotation increments per monthly interval, compared between sides.
Measured: T0, 1 month (T1), 2 months (T2), and 3 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start4 Mar 2024
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth (within-patient) design. Each participant received both interventions simultaneously, one on each side of the maxilla: the guide wire on the randomly allocated side and no guide wire on the contralateral (control) side. Each patient therefore served as their own control, and the two sides - not two groups of patients - form the two arms.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Arici, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845227
- Sponsor's protocol ID
- OMU-2023/259
- Acronym
- PGWCanine
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in a public repository. De-identified data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Palatal Guide Wire on Maxillary Canine Displacement During Miniscrew-Supported Distalization: A Split-Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07845227
- Acronym / sponsor ID
- PGWCanine / OMU-2023/259
- Keywords
- Canine distalization, Palatal guide wire, Miniscrew, Distopalatal rotation, Anchorage, Split-mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 28 Sep 2026 (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.
When crowded or protruded teeth are treated by removing an upper premolar on each side, the canine (eye tooth) is first moved backward into the space. As it moves, the tooth tends to rotate and tip out of position, and this rotation is one of the hardest movements to correct and most likely to come back later. This study tested a simple addition to the usual treatment: a small passive wire attached to the inner (palate) side of the canine and connected to the back tooth, meant to guide the canine and keep it from rotating, without adding any extra force.
Sixteen adolescents who needed an upper premolar removed on both sides took part. Because each person has two sides, every patient received both approaches at once: on one randomly chosen side the guide wire was added, and the other side was treated the same way but without it, serving as that patient's own comparison. This split-mouth design lets each patient act as their own control.
The canine was moved backward on both sides using the same light spring and a small bone screw for anchorage. The researchers took dental scans at the start and after one, two, and three months and measured how far each canine moved, how much it rotated and tipped, and whether the back tooth drifted forward. The goal was to find out whether the guide wire reduces unwanted rotation and tipping and affects how quickly the canine moves, without weakening the anchorage.
Detailed description
This was a prospective, single-center, split-mouth randomized controlled trial conducted in the Department of Orthodontics, Faculty of Dentistry, Ondokuz Mayıs University. Sixteen patients (12 female, 4 male; mean age 16.6 ± 1.7 years) with Angle Class II division 1 or 2 malocclusion requiring bilateral maxillary first premolar extraction with maximum anchorage were enrolled.
In each patient, the side to receive the guide wire was randomly allocated, balanced so that the guide wire was placed on the right side in 8 patients and on the left in 8. Both canines were distalized with a 150-g nickel-titanium closed coil spring extended from an interradicular miniscrew to a U-shaped power arm seated in the vertical slot of the canine bracket. On the experimental side only, a passive 0.020-inch round stainless steel wire was engaged between a bracket bonded to the palatal surface of the canine and the first molar band sheath; this wire was never activated and added no force to the system.
Alginate impressions were taken at the start of distalization (T0) and after 1 (T1), 2 (T2), and 3 (T3) months. Casts were scanned and superimposed on the medial and lateral limits of the third palatal ruga and the medial limit of the second. Distopalatal rotation, canine distalization, canine tipping, and first molar anchorage loss were measured and compared between the guide wire and control sides using paired statistics on the within-patient difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth (within-patient) design. Each participant received both interventions simultaneously, one on each side of the maxilla: the guide wire on the randomly allocated side and no guide wire on the contralateral (control) side. Each patient therefore served as their own control, and the two sides - not two groups of patients - form the two arms.
| Arm | Type | Receives |
|---|---|---|
| Guide wire side | Experimental | Device: Palatal guide wire, Procedure: Miniscrew-supported canine distalizationThe maxillary canine on the randomly allocated side was distalized with a 150-g nickel-titanium closed coil spring from an interradicular miniscrew to a power arm in the vertical slot of the canine bracket, with a passive palatal guide wire engaged between a bracket on the palatal surface of the canine and the first molar band sheath. |
| Control side | Active comparator | Procedure: Miniscrew-supported canine distalizationThe contralateral canine was distalized with the identical coil-spring and power-arm system, without a palatal guide wire. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Angle Class II division 1 or division 2 malocclusion
- Indication for maxillary first premolar extraction
- Maximum anchorage requirement
- Minimal or no maxillary incisor crowding
- No previous orthodontic treatment
Key exclusion criteria (2 listed)
- Any systemic disease or regular medication use
- Poor oral hygiene or active periodontal disease
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 |
|---|---|---|
| Palatal guide wireA passive 0.020-inch round stainless steel wire engaged between a bracket bonded to the palatal surface of the maxillary canine and the first molar band sheath. The wire was never activated and added no force to the distalization system. | Device | Guide wire side |
| Miniscrew-supported canine distalizationDistalization of the maxillary canine with a 150-g nickel-titanium closed coil spring extended from an interradicular miniscrew to a U-shaped power arm seated in the vertical slot of the canine bracket. | Procedure or surgery | Control side, Guide wire side |
Primary outcome
Cumulative distopalatal rotation of the maxillary canine
Time frame: Baseline (T0) and 3 months (T3)
Change from baseline in the angle between the sagittal reference line and a line through the canine cusp tip along the palatal ridge, measured on rugae-superimposed digital models and compared between the guide wire and control sides.
Cumulative canine distalization
Time frame: Baseline (T0) and 3 months (T3)
Change from baseline in the perpendicular distance from the canine cusp tip to the sagittal reference line, compared between the guide wire and control sides.
3 secondary outcomes
Canine tipping
Time frame: Baseline (T0) and 3 months (T3)
First molar anchorage loss
Time frame: Baseline (T0) and 3 months (T3)
Monthly rate of canine distalization and rotation
Time frame: T0, 1 month (T1), 2 months (T2), and 3 months (T3)
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 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in a public repository. De-identified data are available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal guide wire and Miniscrew-supported canine distalization in people with Malocclusion, Angle Class II and Tooth Movement Techniques, run by Atlas 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 7 inclusion and 2 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 6 Oct 2026. 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?
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?
Cumulative distopalatal rotation of the maxillary canine (time frame: Baseline (T0) and 3 months (T3)). 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 6 Oct 2026.