Effect of Force Magnitude on Canine Retraction and Gingival Crevicular Fluid Proteome (NCT06668194) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Force Magnitude on Canine Retraction and Gingival Crevicular Fluid Proteome
United States40 participantsStarted 2024-11-13
Plain-language 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.
Who can participate
Age range
11 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing different force levels to move a tooth — what does that mean for me practically, and would I be in a group using a higher or lower force, and how might that affect my discomfort or treatment timeline?
2Since this study is measuring proteins in the fluid around my gums (gingival crevicular fluid) alongside tooth movement, what does that fluid sampling involve — is it painful, how often would it happen, and are there any risks to my gum tissue?
3This trial is listed as 'Phase NA,' which often applies to device or procedure studies rather than drug trials — so what is already known about the safety of the force levels being tested, and is anything about this approach experimental compared to standard orthodontic care?
4Given that this study is partly a research exercise to analyze proteins related to tooth movement, would participating affect how quickly my crowding is actually treated, or could it slow down or change my overall orthodontic plan?
5Are there standard orthodontic approaches for my tooth crowding that don't involve being part of a research study, and how would you compare the expected outcomes of those options to what this trial is testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.