Orthodontic Force Levels for Canine Retraction Study

This study is looking at how different levels of force affect how quickly teeth move during orthodontic treatment. Specifically, it compares a "Light Force" (150g Niti Coil) to a "Heavy Force" (400g Niti coil) when moving canine teeth back. Researchers want to see if one force level moves teeth faster and how it affects the fluid around your gums (gingival crevicular fluid). You might be able to join if you are between 11 and 16 years old, healthy, a non-smoker, and need to have your first premolars removed as part of your orthodontic treatment. The study aims to enroll 40 participants.

Study design
This interventional study plans to enroll 40 participants. It uses a split-mouth design, meaning different force levels will be applied to the right and left sides of your mouth.
What's involved
You will have an initial visit where orthodontic wires and power arms are placed, and samples of gingival fluid and X-rays are taken. Digital scans of your teeth will also be collected at this first visit and throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The rate of canine retraction will be measured for 16-17 weeks, and gingival crevicular fluid will be analyzed at 4-5 weeks.

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NCT06668194

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

Recruiting
NAAges 11–16InterventionalTreatment
UConn Health
~40 participants
Updated 2024-11-26 on ClinicalTrials.gov
What's tested:Light Force (150g Niti Coil)Heavy Force (400 g Niti coil)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Canine retraction
Measured over 16-17 weeks
+1 more outcome measured
Tooth Crowding
1 sites across 1 states
Connecticut1
  • Flavio Uribe, DDS, MDentSc · PRINCIPAL_INVESTIGATOR · UConn Health

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Eligibility criteria

Inclusion

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

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
  • Rate of Canine retraction16-17 weeks

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

  • Gingival crevicular fluid proteomic analysis4-5 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.