NCT07862790

Brief Summary

In orthodontic treatment involving extraction of the maxillary first premolars, the canine is distalized into the extraction space using sliding mechanics. Because the retraction force is applied at bracket level and therefore at a distance from the centre of resistance of the tooth, the canine tends to rotate distopalatally and to tip in the sagittal plane instead of translating bodily. These side effects lengthen treatment and increase the load on the posterior anchorage teeth. Power arms are used to bring the line of action of the force closer to the centre of resistance. In addition, because the centre of resistance of the maxillary canine lies palatal to the mid-buccolingual axis of the crown, a force applied from the palatal surface generates a rotational moment opposite in direction to that produced by a buccal force. This trial tested whether dividing a constant total distalizing force between the buccal and the palatal surfaces of the canine, so that the two rotational moments oppose one another, produces a more bodily canine movement than applying the whole force from the buccal side alone. The trial used a split-mouth design: in each participant one maxillary quadrant received the whole force from the buccal side and the contralateral quadrant received half the force buccally and half palatally, with the total force identical on both sides. Canine displacement, rotation, tipping and first molar anchorage loss were measured on superimposed digital models over 12 weeks.

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

Shorter than P25 for not_applicable

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 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2026

Completed
Last Updated

October 7, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

October 2, 2026

Last Update Submit

October 2, 2026

Conditions

Keywords

canine distalizationcanine retractionpower armpalatal forcelingual forcesliding mechanicsotrthodontic anchoragesplit-mouth

Outcome Measures

Primary Outcomes (1)

  • Cumulative maxillary canine distalization

    Linear distance, in millimetres, travelled by the maxillary canine cusp tip in the sagittal direction, measured as the distance between the projections of the cusp tip onto a reference line parallel to the midpalatal suture on digital models superimposed on three palatal rugae landmarks.

    From the start of distalization to 3 months

Secondary Outcomes (3)

  • Maxillary canine distopalatal rotation

    From the start of distalization to 3 months

  • Maxillary canine mesiodistal tipping

    From the start of distalization to 3 months

  • Maxillary first molar anchorage loss

    From the start of distalization to 3 months

Study Arms (2)

Buccal plus palatal force

EXPERIMENTAL

The maxillary quadrant randomly allocated to receive the distalizing force from both the buccal and the palatal surfaces. A nickel-titanium closed-coil spring delivered 100 g between the buccal canine power arm and the buccal first molar power arm, and a second spring delivered 100 g between a palatal canine power arm and a palatal first molar power arm, giving 200 g in total. Sixteen quadrants, one in each participant.

Device: Combined buccal and palatal distalizing force

Buccal force only

ACTIVE COMPARATOR

The contralateral maxillary quadrant, in which the distalizing force was applied only from the buccal surface. A single nickel-titanium closed-coil spring delivered 200 g between the buccal canine power arm and the buccal first molar power arm. Sixteen quadrants, one in each participant.

Device: Buccal distalizing force

Interventions

Canine distalization on a 0.019 x 0.025 inch stainless steel archwire using two 9 mm nickel-titanium closed-coil springs. One spring delivers 100 g between a 7 mm buccal canine power arm in the bracket vertical slot and the power arm of the first molar tube; the second delivers 100 g between a palatal canine power arm, placed in the vertical slot of a bracket bonded to the palatal surface of the canine, and a power-arm tube bonded to the palatal surface of the first molar. Total force 200 g. Forces re-measured and reset every four weeks.

Buccal plus palatal force

Canine distalization on a 0.019 x 0.025 inch stainless steel archwire using a single 9 mm nickel-titanium closed-coil spring delivering 200 g between a 7 mm buccal canine power arm in the bracket vertical slot and the power arm of the first molar tube. Force re-measured and reset every four weeks.

Buccal force only

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Indication for fixed orthodontic treatment with bilateral extraction of the maxillary first premolars
  • Moderate anchorage requirement
  • Complete permanent dentition with radiographically closed maxillary canine apices
  • Good oral hygiene, with the ability to maintain it throughout treatment
  • Good cooperation with treatment

You may not qualify if:

  • Previous extraction of any permanent tooth other than third molars
  • Congenitally missing or impacted teeth
  • Systemic disease, or regular use of medication, capable of influencing orthodontic tooth movement
  • Asymmetry, occlusal discrepancy, jaw trauma or developmental disturbance of a degree requiring orthognathic surgery

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

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Selim Arici, DDS, PhD

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Split-mouth (within-person) design. Both interventions were applied simultaneously in every participant, one to each maxillary quadrant, rather than in successive periods. The unit of randomization and analysis was the maxillary quadrant, and the two quadrants of each participant provide paired observations. There was no washout period, as the interventions ran concurrently on anatomically separate sites.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Department of Orthodontics

Study Record Dates

First Submitted

October 2, 2026

First Posted

October 7, 2026

Study Start

January 15, 2024

Primary Completion

November 4, 2024

Study Completion

November 4, 2024

Last Updated

October 7, 2026

Record last verified: 2026-09

Locations