Health TrialsbyHealthPanel

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

ConditionTooth Crowding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-16
SponsorUConn Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Light force (150g Niti Coil Spring)Active comparator 1 intervention
Group B: Heavy force (400g NiTi Coil Spring)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Canine retraction

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

Time frame
16-17 weeks
2

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.

Time frame
4-5 weeks

Secondary outcomes

1

External apical root resorption (EARR)

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.

Time frame
16-17 weeks
2

Maxillary first molar 3 dimensional displacement

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

Time frame
16-17 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UConn Health

Lead sponsor

Charles Burstone Foundation

Collaborator

Source ClinicalTrials.gov
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