Tooth, ImpactedPhase 1NCT00154518
The Role of Matrix Metalloproteinases (MMPs) in Orthodontic Tooth Movement
A Phase 1 study testing Orthodontic treatment in people with Tooth, Impacted and Molar, Third, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to test whether the two MMPs can be up-regulated during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted, Molar, Third
- What is being tested?
- Orthodontic treatment
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2004to Dec 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Two mandibular third molars containing at least one mesially angular impaction with crown exposed to oral cavity
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Dentistry, National Taiwan University Hospital
Taipei
About this study
Official title: The Role of Matrix Metalloproteinases in Orthodontic Treatment
The purpose of this study is to test whether the two MMPs can be up-regulated during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers.
Read the detailed description
Long treatment time is a major factor causing high fees for orthodontic treatment. Patients would have dental caries or periodontitis resulting from improper oral hygiene care during this long treatment period. How to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on a tooth induces bone resorption on the compression side and bone deposition on the tension side, thus the bone remodels and then the tooth moves. Therefore, bone resorption is the rate-limiting step of a lengthy orthodontic treatment.
Bone resorption is a complex process. The mineral component is dissolved by acid from osteoclasts. On the other hand, the organic components are digested with proteolytic enzymes secreted from osteoblasts and osteoclasts. We focus on our study on specific proteases which can digest extracellular matrix, called matrix metalloproteinases (MMPs). Osteoblast-derived MMPs play an important role during initiation of bone resorption. However, the mechanism of its regulation is not clear. The past studies applied stretching or tension on single layer of cultured cells to characterize cellular response to the mechanical stimulation. Now we simulate part of the bone resorption process by cultivating osteocyte-like cells in three-dimensional collagen gel under periodical compression.
In a preliminary study, we focus on transcriptional changes of MMPs upon compression in an osteosarcoma cell line MG-63. Initial data form microarray indicated specific increase of two MMPs expression after one day of compression. This increased expression was specific because the levels of house-keeping genes (ex. Beta-actin or GAPDH) and bone-specific markers were unaltered. Therefore, we proposed that increased MMP expression of osteoblasts under compression is the first step for bone remodeling switching from synthesis to degradation of osteoid. In order to test this hypothesis, the following specific aims will be achieved:
- To test whether these two MMPs can be up-regulated during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers. In situ hybridization and immunohistochemistry analysis for MMPs will reveal their roles in this physiological process.
- To optimize the regulation by changing the magnitude and frequency of the pressure, and characterize the time table for these changes.
- Conditions
- Tooth, Impacted, Molar, Third
- Being tested
- Orthodontic treatment
- Keywords
- orthodontic tooth movement, matrix metalloproteinase, Orthodontics
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue staining with antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chung-Chen Yao, DDS, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154518
- Sponsor's protocol ID
- 9261701411
- Status last verified
- Feb 2013
- First submitted
- 9 Sep 2005
- Last updated
- 22 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Matrix Metalloproteinases in Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT00154518
- Acronym / sponsor ID
- 9261701411
- Conditions
- Tooth, Impacted, Molar, Third
- Keywords
- orthodontic tooth movement, matrix metalloproteinase, Orthodontics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2005
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to test whether the two MMPs can be up-regulated during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers.
Detailed description
Long treatment time is a major factor causing high fees for orthodontic treatment. Patients would have dental caries or periodontitis resulting from improper oral hygiene care during this long treatment period. How to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on a tooth induces bone resorption on the compression side and bone deposition on the tension side, thus the bone remodels and then the tooth moves. Therefore, bone resorption is the rate-limiting step of a lengthy orthodontic treatment.
Bone resorption is a complex process. The mineral component is dissolved by acid from osteoclasts. On the other hand, the organic components are digested with proteolytic enzymes secreted from osteoblasts and osteoclasts. We focus on our study on specific proteases which can digest extracellular matrix, called matrix metalloproteinases (MMPs). Osteoblast-derived MMPs play an important role during initiation of bone resorption. However, the mechanism of its regulation is not clear. The past studies applied stretching or tension on single layer of cultured cells to characterize cellular response to the mechanical stimulation. Now we simulate part of the bone resorption process by cultivating osteocyte-like cells in three-dimensional collagen gel under periodical compression.
In a preliminary study, we focus on transcriptional changes of MMPs upon compression in an osteosarcoma cell line MG-63. Initial data form microarray indicated specific increase of two MMPs expression after one day of compression. This increased expression was specific because the levels of house-keeping genes (ex. Beta-actin or GAPDH) and bone-specific markers were unaltered. Therefore, we proposed that increased MMP expression of osteoblasts under compression is the first step for bone remodeling switching from synthesis to degradation of osteoid. In order to test this hypothesis, the following specific aims will be achieved:
- To test whether these two MMPs can be up-regulated during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different periods of time in volunteers. In situ hybridization and immunohistochemistry analysis for MMPs will reveal their roles in this physiological process.
- To optimize the regulation by changing the magnitude and frequency of the pressure, and characterize the time table for these changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Two mandibular third molars containing at least one mesially angular impaction with crown exposed to oral cavity
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Orthodontic treatment | Procedure or surgery | – |
Primary outcome
Tissue staining with antibody
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 22 Feb 2013.
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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.
Chung-Chen Yao, DDS, PhD principal investigator
National Taiwan University Hospital
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 Orthodontic treatment in people with Tooth, Impacted and Molar, Third, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 22 Feb 2013. 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 Taiwan. 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?
Tissue staining with antibody. 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 22 Feb 2013.