Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06668194

Effect of Force Magnitude on Canine Retraction and Gingival Crevicular Fluid Proteome

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics

Farmington, Connecticut, 06032, United States

Location status: Recruiting

Location contact

Flavio Uribe, DDS, MDentSc

CONTACT

[email protected]

860-679-2664

Flavio Uribe, DDS, MDentSc

CONTACT

Georgiana Defilio

CONTACT

860-679-2550

About this study

Patients' participation in the study at the first visit (T0) Timepoint 0, 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.

At the T0 appointment, before applying the retraction force, periapical radiographs of canines (with coronal and apical reference wires for calibration and magnification correction) and GCF (gingival crevicular fluid) samples of each canine will be collected. Gingival sulcus of mesial and distal to canine (bilaterally) will be chosen as sites for GCF sample collection. The study coordinator will take a digital scan using iTero® Element™ in the clinic as the baseline (T0). As the split-mouth design will be applied in this study, right and left sides will be assigned randomly for either 150gm (light force) or 400gm force (heavy force) for each subject. NiTi coil spring calibrated for force magnitude at oral temperature will be used to deliver the assigned force will be engaged from the first molars to the canine power arms. IRB-approved written instructions will also be provided to all the participants. Follow-up visits will be scheduled. After applying the force, follow-up visits will be scheduled at (T1) 1-2 weeks, (T2) 4-5 weeks, (T3) 8-9 weeks, (T4)12-13 weeks, and (T5)16-17 weeks. A new digital scan will be taken at each study appointment (T0 - T5). These digital scans will be used for tooth movement measurements. GCF samples (mesial and distal to canines bilaterally) will be collected only for the first 3 appointments (T0 - T2) for the first 10 participants only in this study.

Periapical radiographs for canines on both sides will be obtained on (T0) Timepoint 0, and (T3) 8-9 weeks and (T5) 16-17 weeks of the study for each participant and analyzed to measure the EARR (external apical root resorption). Following the last study visit, all subjects' treatment will continue as recommended by the primary orthodontic care provider. No new data will be reviewed or collected after (T5).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Rate of Canine retraction

    Time frame: 16-17 weeks

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

  2. Gingival crevicular fluid proteomic analysis

    Time frame: 4-5 weeks

    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.

Secondary outcomes

  1. External apical root resorption (EARR)

    Time frame: 16-17 weeks

    The amount of root resorption on the canines as they are being retracted will be measured radiographically before starting retraction, at 8-9 weeks, and at 16-17 weeks.

  2. Maxillary first molar 3 dimensional displacement

    Time frame: 16-17 weeks

    Maxillary first molar displacement in response to a heavy and light force will be characterized in 3D through the 17 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Flavio Uribe, DDS, MDentSc

CONTACT

[email protected]

860-679-2664

Georgiana Defilio

CONTACT

860-679-2550

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Charles Burstone Foundation

Registry information

Official study title

A Randomized Clinical Trial Comparing the Effect of Force Magnitude on the Rate of Canine Retraction and Gingival Crevicular Fluid Proteome Profile

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 31, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.