Malocclusion, Angle Class IIIPhase 1NCT00099814
Periodontal Ligament Stress Level and Tooth Movement
A Phase 1 study testing Two different loop designs which deliver distinctive forces in people with Malocclusion, Angle Class III, run by University of Alberta at 1 site in Canada.
Trial summary
Orthodontic treatment requires application of force systems to individual teeth or groups of teeth, which results in a cellular response with periodontal ligament (PDL) and alveolar bone remodeling. Read more about this study
- Who is it for?
- Ages 12 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class III
- What is being tested?
- Two different loop designs which deliver distinctive forces
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2004to Nov 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female adolescent (12-16 years old) orthodontic patients requiring upper first premolars extractions for overjet reduction.
- Participants will be healthy and not taking any medications.
- All participants will have healthy periodontal tissues and good oral hygiene.
Who cannot join
- Patients with medical contraindication for placement of a palatal implant.
- All candidates who admit to tobacco utilization will be excluded.
- Patients requiring lower dental extractions will also be excluded.
- Pregnant patients or patients planning pregnancy will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Orthodontic Clinic - Department of Dentistry - University of Alberta
Edmonton, Alberta, T6G 2N8
About this study
Official title: Clinical/Numerical Study of the Effects of Periodontal Ligament Stress Level on the Rate Bodily Tooth Movement
Orthodontic treatment requires application of force systems to individual teeth or groups of teeth, which results in a cellular response with periodontal ligament (PDL) and alveolar bone remodeling. The forces applied must be of sufficient magnitude and duration to exceed the normal physiologic threshold associated with daily oral function. Excessive force levels will result in areas of tissue necrosis with delayed tooth movement and increased risk of root resorption. Although orthodontic tooth movement is achieved in a large segment of the population, the optimum force level has not been defined. The optimum force for tooth movement depends on individual root geometry as well as biologic characteristics of surrounding tissue including bone density, periodontal thickness, and fluid dynamics.
Because experimental and clinical techniques are generally limited to known complex force systems, biomechanical modeling has become a necessity. Such models must be validated with well-controlled clinical studies that evaluate orthodontic tooth movement over an extended distance. The ultimate goal would be development of a computer simulation model to predict tooth movement in the clinical setting.
Read more
The primary objective of this study is to test controlled clinical data with a biomechanical model of the tooth and supporting tissues for distal movement of the human maxillary canine tooth (of known root geometry) in response to various 3D force systems that produce different levels of stress in the supporting tissues. Secondary objectives include evaluation of rate of bodily tooth canine movement with two known compressive stress levels (13 and 22 kPa), evaluation of three different reference systems to measure rate of tooth movement, and evaluation of an implant placed in the roof of the mouth (palatal implant) for orthodontic anchorage in adolescent patients.
The rate of translation (bodily) tooth movement of the maxillary canine tooth will be significantly greater with 22kPa compared to 13kPa compressive stress applied to the periodontal ligament, and this difference can be predicted by appropriate mathematical/numerical models of the tooth and supporting tissues.
Read the detailed description
The patients will be drawn from those recruited for the Graduate Orthodontic Graduate Program. Clinical academic staff will examine approximately 500 patients seeking orthodontic care. Patients are categorized by malocclusion type and placed into a patient pool from which some cases are selected for treatment based on the program teaching and research needs. Each year approximately 50% of patients seeking care are ultimately accepted. Treatment is provided at fees that are approximately 60% of those charged in private practice.
Patients who meet the selection criteria for this study will be randomly selected from the University of Alberta Graduate Orthodontic Graduate Clinic patient pool. Upper 1st premolar teeth will be extracted and full fixed orthodontic appliances (Ormco Orthos prescription) will be placed. After the initial alignment and leveling phase is completed the retraction phase will begin. Non-steroidal anti-inflammatory agents will be avoided; only extra strength Tylenol will be prescribed as necessary for any momentary pain or discomfort. Maximum posterior anchorage will be attained through a palatal implant (Straumann) according to the protocol described by Papadakis. The implants will be also used as three-dimensional movement reference points. Other reference systems to be used include the palatal ruggae and occlusal templates. The cuspid retraction force delivery mechanisms will consist of customized activated stainless steel T-loops designed to generate the required forces on the bracket. Approximate compressive stress (based on approximate root surface area) of 13 kPa and 22 kPa will be applied on the distal aspect of the cuspids. The design will be a split-mouth study in which both levels of stress will be applied in each patient. The side to which the higher and lower stress levels are applied will be randomized. This design will allow for inter and intra-patient comparisons since each patient will see both stress levels. After the initial activation the subjects will be seen at day 1, 3, 17 and thereafter at 4-week intervals until the space between the cuspid and second bicuspid is completely closed. In the initial activation session and each of the follow-up sessions, maxillary impressions and appliance adjustments to apply the desired force will be made. At each clinical visit impressions will be made of the activated T-loop and the teeth. The geometry of the T-loop will be measured from the impressions which will allow for the applied force to be calculated using a numerical method developed by Raboud. The impression of the teeth will be used to construct the occlusal templates required to measure tooth movement.
Tooth mobility change during the orthodontic tooth movement will be monitored by means of the Periotest measuring device. CT volumetric scans with the NewTom machine will be made just before placement of the implant to ensure adequate palatal bone volume. Extra CT volumetric scans will be repeated in the middle of the retraction period (based on the space to be closed) and at the end of the space closure. The CT volumetric scan images will also be used to determine alveolar bone density, changes in root geometry for calculation of root surface area and center of resistance. The CT volumetric scans will also be used to determine alveolar bone density, change in root geometry (root resorption) and to assess movement of the cuspid in relation to other maxillary structures. The series of models from each subject and a 3-axis measuring system (MicroVal) will be used to measure tooth position changes relative to the 3 reference systems.
At the completion of cuspid retraction, the balance of the required orthodontic treatment will continue. The palatal implant will be retrieved and orthodontic retention delivered. Data gathered in the patient study will be utilized to validate the biomechanical model.
Biomechanical Modeling:
There will be two separate biomechanical tooth models developed. The first will be a parametric three dimensional model of the tooth and supporting tissues which will allow for variable biological properties of the tooth, PDL and alveolar bone. This model allows the inputs to be patient specific for both the force systems applied and the individual biological parameters. The three dimensional force systems that are applied to the tooth will be calculated using the numerical method described by Raboud and the measured geometry of the T-loop. The Finite Element Model (FEM) of the tooth and supporting tissue and the applied force system will allow for an improved description of the stress fields in the tissues, in particular the PDL. This improved stress field will be compared to the resulting bodily tooth movement. In order to compare the results from the biomechanical model and the clinical study it is important that the posterior segment does not move. The palatal implant is to ensure the absolute anchorage required.
As previously mentioned, the accuracy of the FEM model is dependant upon the input parameters. Consequently, there will be a two dimensional dynamic model of the tooth response to a mechanical impact. This will model instruments such as the Periotest® which is designed to measure impact response. Since the tooth response is governed by the characteristics of the periodontal ligament, analysis of the raw signal obtained from the Periotest® will allow for the mechanical properties of the PDL to be evaluated during the retraction.
Statistical Analysis:
The final mean rate of tooth movement between the two force levels will be compared through the Independent Samples T Test. To evaluate significant changes of the tooth movement in the distinctive time intervals, a repeated measure ANOVA will be used. If the underlying assumptions for both methods are not satisfied, then the non-parametric alternative will be considered (U Mann-Whitney Test).
- Conditions
- Malocclusion, Angle Class III
- Being tested
- Two different loop designs which deliver distinctive forces
- Keywords
- tooth movement, orthodontics, force, humans, clinical trial
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two different loop designs which deliver distinctive forcesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of space closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2004 (estimated)
- Study startMar 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIIStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099814
- Sponsor's protocol ID
- GOP-UA-CT-01
- Status last verified
- Nov 2024
- First submitted
- 21 Dec 2004
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical/Numerical Study of the Effects of Periodontal Ligament Stress Level on the Rate Bodily Tooth Movement
- ClinicalTrials.gov ID
- NCT00099814
- Acronym / sponsor ID
- GOP-UA-CT-01
- Conditions
- Malocclusion, Angle Class III
- Keywords
- tooth movement, orthodontics, force, humans, clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 21 Dec 2004 (estimated)
- 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.
Orthodontic treatment requires application of force systems to individual teeth or groups of teeth, which results in a cellular response with periodontal ligament (PDL) and alveolar bone remodeling. The forces applied must be of sufficient magnitude and duration to exceed the normal physiologic threshold associated with daily oral function. Excessive force levels will result in areas of tissue necrosis with delayed tooth movement and increased risk of root resorption. Although orthodontic tooth movement is achieved in a large segment of the population, the optimum force level has not been defined. The optimum force for tooth movement depends on individual root geometry as well as biologic characteristics of surrounding tissue including bone density, periodontal thickness, and fluid dynamics.
Because experimental and clinical techniques are generally limited to known complex force systems, biomechanical modeling has become a necessity. Such models must be validated with well-controlled clinical studies that evaluate orthodontic tooth movement over an extended distance. The ultimate goal would be development of a computer simulation model to predict tooth movement in the clinical setting.
The primary objective of this study is to test controlled clinical data with a biomechanical model of the tooth and supporting tissues for distal movement of the human maxillary canine tooth (of known root geometry) in response to various 3D force systems that produce different levels of stress in the supporting tissues. Secondary objectives include evaluation of rate of bodily tooth canine movement with two known compressive stress levels (13 and 22 kPa), evaluation of three different reference systems to measure rate of tooth movement, and evaluation of an implant placed in the roof of the mouth (palatal implant) for orthodontic anchorage in adolescent patients.
The rate of translation (bodily) tooth movement of the maxillary canine tooth will be significantly greater with 22kPa compared to 13kPa compressive stress applied to the periodontal ligament, and this difference can be predicted by appropriate mathematical/numerical models of the tooth and supporting tissues.
Detailed description
The patients will be drawn from those recruited for the Graduate Orthodontic Graduate Program. Clinical academic staff will examine approximately 500 patients seeking orthodontic care. Patients are categorized by malocclusion type and placed into a patient pool from which some cases are selected for treatment based on the program teaching and research needs. Each year approximately 50% of patients seeking care are ultimately accepted. Treatment is provided at fees that are approximately 60% of those charged in private practice.
Patients who meet the selection criteria for this study will be randomly selected from the University of Alberta Graduate Orthodontic Graduate Clinic patient pool. Upper 1st premolar teeth will be extracted and full fixed orthodontic appliances (Ormco Orthos prescription) will be placed. After the initial alignment and leveling phase is completed the retraction phase will begin. Non-steroidal anti-inflammatory agents will be avoided; only extra strength Tylenol will be prescribed as necessary for any momentary pain or discomfort. Maximum posterior anchorage will be attained through a palatal implant (Straumann) according to the protocol described by Papadakis. The implants will be also used as three-dimensional movement reference points. Other reference systems to be used include the palatal ruggae and occlusal templates. The cuspid retraction force delivery mechanisms will consist of customized activated stainless steel T-loops designed to generate the required forces on the bracket. Approximate compressive stress (based on approximate root surface area) of 13 kPa and 22 kPa will be applied on the distal aspect of the cuspids. The design will be a split-mouth study in which both levels of stress will be applied in each patient. The side to which the higher and lower stress levels are applied will be randomized. This design will allow for inter and intra-patient comparisons since each patient will see both stress levels. After the initial activation the subjects will be seen at day 1, 3, 17 and thereafter at 4-week intervals until the space between the cuspid and second bicuspid is completely closed. In the initial activation session and each of the follow-up sessions, maxillary impressions and appliance adjustments to apply the desired force will be made. At each clinical visit impressions will be made of the activated T-loop and the teeth. The geometry of the T-loop will be measured from the impressions which will allow for the applied force to be calculated using a numerical method developed by Raboud. The impression of the teeth will be used to construct the occlusal templates required to measure tooth movement.
Tooth mobility change during the orthodontic tooth movement will be monitored by means of the Periotest measuring device. CT volumetric scans with the NewTom machine will be made just before placement of the implant to ensure adequate palatal bone volume. Extra CT volumetric scans will be repeated in the middle of the retraction period (based on the space to be closed) and at the end of the space closure. The CT volumetric scan images will also be used to determine alveolar bone density, changes in root geometry for calculation of root surface area and center of resistance. The CT volumetric scans will also be used to determine alveolar bone density, change in root geometry (root resorption) and to assess movement of the cuspid in relation to other maxillary structures. The series of models from each subject and a 3-axis measuring system (MicroVal) will be used to measure tooth position changes relative to the 3 reference systems.
At the completion of cuspid retraction, the balance of the required orthodontic treatment will continue. The palatal implant will be retrieved and orthodontic retention delivered. Data gathered in the patient study will be utilized to validate the biomechanical model.
Biomechanical Modeling:
There will be two separate biomechanical tooth models developed. The first will be a parametric three dimensional model of the tooth and supporting tissues which will allow for variable biological properties of the tooth, PDL and alveolar bone. This model allows the inputs to be patient specific for both the force systems applied and the individual biological parameters. The three dimensional force systems that are applied to the tooth will be calculated using the numerical method described by Raboud and the measured geometry of the T-loop. The Finite Element Model (FEM) of the tooth and supporting tissue and the applied force system will allow for an improved description of the stress fields in the tissues, in particular the PDL. This improved stress field will be compared to the resulting bodily tooth movement. In order to compare the results from the biomechanical model and the clinical study it is important that the posterior segment does not move. The palatal implant is to ensure the absolute anchorage required.
As previously mentioned, the accuracy of the FEM model is dependant upon the input parameters. Consequently, there will be a two dimensional dynamic model of the tooth response to a mechanical impact. This will model instruments such as the Periotest® which is designed to measure impact response. Since the tooth response is governed by the characteristics of the periodontal ligament, analysis of the raw signal obtained from the Periotest® will allow for the mechanical properties of the PDL to be evaluated during the retraction.
Statistical Analysis:
The final mean rate of tooth movement between the two force levels will be compared through the Independent Samples T Test. To evaluate significant changes of the tooth movement in the distinctive time intervals, a repeated measure ANOVA will be used. If the underlying assumptions for both methods are not satisfied, then the non-parametric alternative will be considered (U Mann-Whitney Test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Female adolescent (12-16 years old) orthodontic patients requiring upper first premolars extractions for overjet reduction.
- Participants will be healthy and not taking any medications.
- All participants will have healthy periodontal tissues and good oral hygiene.
Key exclusion criteria (4 listed)
- Patients with medical contraindication for placement of a palatal implant.
- All candidates who admit to tobacco utilization will be excluded.
- Patients requiring lower dental extractions will also be excluded.
- Pregnant patients or patients planning pregnancy will be excluded.
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 |
|---|---|---|
| Two different loop designs which deliver distinctive forces | Procedure or surgery | – |
Primary outcome
Rate of space closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Two different loop designs which deliver distinctive forces in people with Malocclusion, Angle Class III, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of space closure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.