NCT06668194

Brief Summary

This study aims to examine the effect of force levels in orthodontic treatment during canine retraction. Force levels refer to the pressure applied by the orthodontic devices to move teeth. Data collection will include gingival fluid, dental molds from a digital scanner, and x-rays of the upper canine region on both sides of the mouth during treatment. The null hypothesis to be tested is that there is no significant difference in the rate of canine movement between the light force and the heavy force levels.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress44%
Nov 2024Apr 2028

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

November 13, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

November 26, 2024

Status Verified

October 1, 2024

Enrollment Period

2.9 years

First QC Date

October 30, 2024

Last Update Submit

November 23, 2024

Conditions

Tooth Crowding

Keywords

Orthodontic space closureCanine retractionGingival crevicular fluidProteomics

Outcome Measures

Primary Outcomes (2)

  • Rate of Canine retraction

    Amount of canine distal displacement in all 3 dimensions with 6 degrees of freedom will be measured through 17 weeks

    16-17 weeks

  • Gingival crevicular fluid proteomic analysis

    Collected GCF samples from time point (T0, T1 and T2) and same sides (left or right) and aspect of tooth (mesial or distal) from 10 patients for each of the maxillary canines (total of 12 samples per patient). GCF will be collected for the following time points: T0, T1, and T3. A total of 120 samples will be sent for a non-labeled method of proteomic analysis. This will indicate the change in expression of various proteins in GCF samples throughout treatment.

    4-5 weeks

Secondary Outcomes (2)

  • External apical root resorption (EARR)

    16-17 weeks

  • Maxillary first molar 3 dimensional displacement

    16-17 weeks

Study Arms (2)

Light force (150g Niti Coil Spring)

ACTIVE COMPARATOR

One of the maxillary canines to be retracted will be assigned to the light force group randomly. Patients' participation in the study (T0) will be started at the stage of canine retraction. At this appointment, 0.019 x 0.025-inch stainless steel archwire will be placed; power arms will be fabricated from 17x25-inch stainless steel on the maxillary first molars and canines. The height of the power arm will be matched with the center of resistance of both canines and molars based on the root length measured on the periapical radiographs. The archwire will be engaged in the canine bracket using stainless steel ligature wire. NiTi coil spring calibrated for force magnitude (150g) at oral temperature will be used to deliver the assigned force will be engaged from the first molars to the canine power arms.

Device: Light Force (150g Niti Coil)

Heavy force (400g NiTi Coil Spring)

EXPERIMENTAL

One side of the maxillary canines to be retracted will have a heavy force assigned randomly. Patients' participation in the study (T0) will be started at the stage of canine retraction. At this appointment, 0.019 x 0.025-inch stainless steel archwire will be placed; power arms will be fabricated from 17x25-inch stainless steel on the maxillary first molars and canines. The height of the power arm will be matched with the center of resistance of both canines and molars based on the root length measured on the periapical radiographs. The archwire will be engaged in the canine bracket using stainless steel ligature wire. NiTi coil spring calibrated for force magnitude (400g) at oral temperature will be used to deliver the assigned force will be engaged from the first molars to the canine power arms.

Device: Heavy Force (400 g Niti coil)

Interventions

Light Force (150g Niti Coil)DEVICE

Patients' participation in the study (T0) will be started at the stage of canine retraction. At this appointment, 0.019 x 0.025-inch stainless steel archwire will be placed; power arms will be fabricated from 17x25-inch stainless steel on the maxillary first molars and canines. The height of the power arm will be matched with the center of resistance of both canines and molars based on the root length measured on the periapical radiographs. The archwire will be engaged in the canine bracket using stainless steel ligature wire. NiTi coil spring calibrated for force magnitude (150g) at oral temperature will be used to deliver the assigned force will be engaged from the first molars to the canine power arms

Light force (150g Niti Coil Spring)
Heavy Force (400 g Niti coil)DEVICE

Patients' participation in the study (T0) will be started at the stage of canine retraction. At this appointment, 0.019 x 0.025-inch stainless steel archwire will be placed; power arms will be fabricated from 17x25-inch stainless steel on the maxillary first molars and canines. The height of the power arm will be matched with the center of resistance of both canines and molars based on the root length measured on the periapical radiographs. The archwire will be engaged in the canine bracket using stainless steel ligature wire. NiTi coil spring calibrated for force magnitude (400g) at oral temperature will be used to deliver the assigned force will be engaged from the first molars to the canine power arms

Heavy force (400g NiTi Coil Spring)

Eligibility Criteria

Age11 Years - 16 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale and female
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy patient, non-smoker
  • Age: 11 - 16 years of age, inclusive.
  • A full complement of dentition (central incisor to 1st molar) in the four quadrants, except second molars
  • Patients requiring at least upper bilaterally maxillary 1st premolar extraction as a treatment plan (Class I bimaxillary protrusion/ crowding or Class II maxillary dentoalveolar protrusion/ crowding)
  • At least 5 mm of space left between canine and 2nd premolar to be closed at the time of canine retraction
  • At least six months after the extraction of first premolars and in a 0.019 x 0.025-inch stainless steel archwire in the maxilla
  • The ability to read and understand English and to provide informed consent

You may not qualify if:

  • Patients under 11 years of age and over the age of 16.
  • Non-extraction treatment plan
  • Extraction of maxillary tooth other than first premolars bilaterally.
  • Evidence of poor oral hygiene
  • Evidence of previous root resorption
  • Missing or impacted tooth in any of the quadrant except 3rd molars.
  • Medical issues that affect tooth movement
  • Inability to provide oral and written consent to participate.
  • Patient on medications that may alter bone metabolisms like bisphosphonates, oral contraceptives, or PTH (parathyroid hormone)
  • Chronic illness or syndromic patients.
  • Pregnant women, prisoners, and decisional impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics

Farmington, Connecticut, 06032, United States

RECRUITING

Related Publications (3)

  • Ren Y, Maltha JC, Van 't Hof MA, Kuijpers-Jagtman AM. Optimum force magnitude for orthodontic tooth movement: a mathematic model. Am J Orthod Dentofacial Orthop. 2004 Jan;125(1):71-7. doi: 10.1016/j.ajodo.2003.02.005.

    PMID: 14718882BACKGROUND

  • Yee JA, Turk T, Elekdag-Turk S, Cheng LL, Darendeliler MA. Rate of tooth movement under heavy and light continuous orthodontic forces. Am J Orthod Dentofacial Orthop. 2009 Aug;136(2):150.e1-9; discussion 150-1. doi: 10.1016/j.ajodo.2009.03.026.

    PMID: 19651334BACKGROUND

  • Iwasaki LR, Liu Y, Liu H, Nickel JC. Speed of human tooth movement in growers and non-growers: Selection of applied stress matters. Orthod Craniofac Res. 2017 Jun;20 Suppl 1:63-67. doi: 10.1111/ocr.12161.

    PMID: 28643922BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Flavio Uribe, DDS, MDentSc

    UConn Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavio Uribe, DDS, MDentSc

CONTACT

860-679-2664furibe@uchc.edu

Georgiana Defilio

CONTACT

860-679-2550

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Split mouth design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 30, 2024

First Posted

October 31, 2024

Study Start

November 13, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

November 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Data on primary and secondary outcomes

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
IPD will be available approximately 1 year after recruiting the first patient and 1 year after the recruitment of the last patient.
Access Criteria
A data sharing agreement must be signed. The documents should be submitted to the PI by email at furibe@uchc.edu

Locations

US(1)