Palatal Guide Wire for Canine Control During Miniscrew-Supported Distalization

NCT07845227 | Completed

• 1 other identifier: OMU-2023/259
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Malocclusion, Angle Class II; Tooth Movement Techniques

Keywords

Canine distalization; Palatal guide wire; Miniscrew; Distopalatal rotation; Anchorage; Split-mouth

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (T0) and 3 months (T3)

Secondary Outcomes (3)

• Canine tipping

  Baseline (T0) and 3 months (T3)

• First molar anchorage loss

  Baseline (T0) and 3 months (T3)

• Monthly rate of canine distalization and rotation

  T0, 1 month (T1), 2 months (T2), and 3 months (T3)

Study Arms (2)

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.

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.

Procedure: Miniscrew-supported canine distalization

Interventions

Palatal guide wire DEVICE

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.

Guide wire side

Miniscrew-supported canine distalization PROCEDURE

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.

Control side; Guide wire side

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any systemic disease or regular medication use
• Poor oral hygiene or active periodontal disease

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Ondokuz Mayıs University, Faculty of Dentistry, Department of Orthodontics

Samsun, Marmara, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The operator was blinded to allocation until the T0 appointment, so the side to receive the guide wire was unknown during the preparatory phase. Blinding could not be maintained thereafter because the palatal attachment is visible both intraorally and on the scanned casts; no party could be masked once the appliance was placed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: March 4, 2024
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)