NCT07866976

Brief Summary

The aim of this study is to investigate the effects of a canine distalization force applied between power arms placed on the maxillary canine and first molar, in comparison with the classical method without power arms. Following maxillary first premolar extraction, canine distalization is commonly accompanied by undesirable effects such as distal tipping and distopalatal rotation of the canine and mesial movement (anchorage loss) of the first molar. By bringing the applied force closer to the teeth's centers of resistance through power arms, the study seeks to move the canine into the extraction space as close to parallel (bodily) movement as possible. The hypothesis is that applying force with Ni-Ti closed-coil springs between power arms placed on the molar and canine teeth reduces undesirable dental effects such as rotation, tipping and anchorage loss during distalization compared with the classical method. In a split-mouth design, 16 patients with maxillary first premolar extractions and moderate anchorage requirement receive power-arm mechanics on one randomly selected side (study side) and conventional mechanics on the other side (control side), with a 150 g force on both sides, over three months of canine distalization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

1.1 years

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

canine retractionpower armanchorage losssplit-mouthclosed-coil springcenter of resistance

Outcome Measures

Primary Outcomes (1)

  • Canine distalization

    Distal movement of the maxillary canine cusp tip (mm), measured on superimposed 3D digital models as the distance between successive cusp-tip projections on a reference line parallel to the midpalatal raphe. Reported per month and cumulatively.

    Baseline (T0), 1, 2 and 3 months of retraction; cumulative T0 to 3 months

Secondary Outcomes (3)

  • First molar anchorage loss

    Baseline (T0), 1, 2 and 3 months; cumulative T0 to 3 months

  • Canine rotation

    Baseline (T0), 1, 2 and 3 months; cumulative T0 to 3 months

  • Canine tipping

    Baseline (T0), 1, 2 and 3 months; cumulative T0 to 3 months

Study Arms (2)

Study side (power arms)

EXPERIMENTAL

Study side (power arms)

Device: Canine and molar power arms

Control side (classical method)

ACTIVE COMPARATOR

Contralateral maxillary canine retracted on the same archwire with a 150 g Ni-Ti closed-coil spring activated between the molar tube hook and the canine bracket hook, without power arms.

Procedure: Conventional canine retraction

Interventions

Molar tube with a power arm and a U-shaped canine power arm bent from 0.016 x 0.022-inch stainless steel wire (gingival opening facing mesially), adjusted to the molar power-arm height; a 9-mm Ni-Ti closed-coil spring is attached between the two power-arm hooks via a 0.010-inch long ligature wire and activated to 150 g measured with a force gauge.

Study side (power arms)

9-mm Ni-Ti closed-coil spring delivering 150 g attached directly between the molar tube hook and the canine bracket hook.

Also known as: Sliding mechanics canine retraction
Control side (classical method)

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Maxillary skeletal/dental Angle Class II malocclusion
  • Indication for fixed orthodontic treatment with bilateral maxillary first premolar extraction and moderate anchorage requirement
  • No systemic disease and no medication use
  • No congenitally missing or previously extracted maxillary teeth (third molars excepted)
  • Good oral hygiene and healthy periodontal tissues

You may not qualify if:

  • Systemic disease or medication use
  • Anomalies of tooth number or shape in the maxillary dentition
  • Inadequate oral hygiene
  • Pubertal growth spurt not yet completed
  • Previous orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University, Faculty of Dentistry, Department of Orthodontics

Samsun, 55139, Turkey (Türkiye)

Location

MeSH Terms

Conditions

MalocclusionMalocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Selim Arici, DDS, PhD

    Atlas University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No blinding was described; the power-arm molar tube identifies the study side, and impressions, scanning and all measurements were performed by the same investigator.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split-mouth design: within each participant, the right and left maxillary quadrants were randomly allocated to the experimental (power arm) or control (conventional) canine retraction mechanics. Each of the 16 participants contributes one quadrant to each arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start

January 22, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data are not deposited in a public repository; de-identified data are available from the corresponding author on reasonable request.

Locations