Tooth CrowdingNCT06668194
Effect of Force Magnitude on Canine Retraction and Gingival Crevicular Fluid Proteome
A study testing Light Force (150g Niti Coil) and Heavy Force (400 g Niti coil) in people with Tooth Crowding, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Crowding
- What is being tested?
- Light Force (150g Niti Coil) and Heavy Force (400 g Niti coil)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Georgiana Defilio contact
United States1 site, 1 recruiting
- Recruiting
Department of Orthodontics
Farmington, Connecticut, 06032
Flavio Uribe, DDS, MDentSc, 860-679-2664, furibe@uchc.edu
Georgiana Defilio, 860-679-2550
About this study
Official title: A Randomized Clinical Trial Comparing the Effect of Force Magnitude on the Rate of Canine Retraction and Gingival Crevicular Fluid Proteome Profile
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.
Read the detailed description
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).
- Conditions
- Tooth Crowding
- Being tested
- Light Force (150g Niti Coil), Heavy Force (400 g Niti coil)
- Keywords
- Orthodontic space closure, Canine retraction, Gingival crevicular fluid, Proteomics
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Heavy Force (400 g Niti coil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Canine retraction
Amount of canine distal displacement in all 3 dimensions with 6 degrees of freedom will be measured through 17 weeks
Measured: 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.
Measured: 4-5 weeks
Secondary outcomes (2)
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.
Measured: 16-17 weeks
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.
Measured: 16-17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start13 Nov 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth CrowdingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Split mouth design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Charles Burstone Foundation
- Responsible party
- Principal investigator, Flavio Uribe, UConn Health
- Investigators
- Flavio Uribe, DDS, MDentSc, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668194
- Sponsor's protocol ID
- 22-314-2
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data on primary and secondary outcomes
Publications
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.
PubMed 14718882Yee 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.
PubMed 19651334Iwasaki 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.
PubMed 28643922
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing the Effect of Force Magnitude on the Rate of Canine Retraction and Gingival Crevicular Fluid Proteome Profile
- ClinicalTrials.gov ID
- NCT06668194
- Acronym / sponsor ID
- 22-314-2
- Conditions
- Tooth Crowding
- Keywords
- Orthodontic space closure, Canine retraction, Gingival crevicular fluid, Proteomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Charles Burstone Foundation
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design
| Arm | Type | Receives |
|---|---|---|
| Light force (150g Niti Coil Spring) | Active comparator | Device: Light Force (150g Niti Coil)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. |
| Heavy force (400g NiTi Coil Spring) | Experimental | Device: Heavy Force (400 g Niti coil)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. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light Force (150g Niti Coil)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 Spring) |
| Heavy Force (400 g Niti coil)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 (400g NiTi Coil Spring) |
Primary outcome
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
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.
2 secondary outcomes
External apical root resorption (EARR)
Time frame: 16-17 weeks
Maxillary first molar 3 dimensional displacement
Time frame: 16-17 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 14718882Ren 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.
- Background: PubMed 19651334Yee 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.
- Background: PubMed 28643922Iwasaki 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.
- Individual participant dataSharing planned: Yes. Data on primary and secondary outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgiana Defilio contact
Flavio Uribe, DDS, MDentSc principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Force (150g Niti Coil) and Heavy Force (400 g Niti coil) in people with Tooth Crowding, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavio Uribe, DDS, MDentSc (860-679-2664, furibe@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Canine retraction (time frame: 16-17 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06668194, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.