MalocclusionMTtorqueNCT07780149
Maximum Clinical Insertion Torque and Its Association With the Success Rate of Orthodontic Miniscrews
An observational study of Malocclusion, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
Orthodontic miniscrews provide temporary skeletal anchorage but are lost prematurely in a proportion of cases despite correct placement. The insertion torque generated when a miniscrew is seated has been proposed as a marker of primary stability, but its relationship with clinical success remains uncertain and the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- microscrew
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteChile
- Study dates
- 7 Aug 2020to 1 Sep 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with indication for insertion of orthodontic mini-screws as an orthodontic anchorage device, attended at the Postgraduate Orthodontic Clinic of CESA, Universidad de los Andes, San Bernardo, Chile.
Who may be able to join
- - Patients undergoing orthodontic treatment and who have a clinical indication for skeletal anchorage using mini-screws.
- Patients who freely and voluntarily accept the procedure as part of their orthodontic treatment.
- Patients who freely and voluntarily consent or agree to the use of their TM installation and evolution data as part of their orthodontic treatment.
Who cannot join
- - Patients with craniofacial syndromes.
- Patients with uncontrolled systemic disease.
- Patients with active periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Orthodontic miniscrews provide temporary skeletal anchorage but are lost prematurely in a proportion of cases despite correct placement. The insertion torque generated when a miniscrew is seated has been proposed as a marker of primary stability, but its relationship with clinical success remains uncertain and the existing evidence is limited. This prospective observational cohort study evaluated orthodontic miniscrews placed for skeletal anchorage during routine fixed orthodontic treatment at the postgraduate orthodontic clinic of Universidad de los Andes, Santiago, Chile. The primary objective was to determine whether the maximum clinical insertion torque measured at placement is associated with miniscrew success. Maximum insertion torque and patient-, device-, site-, and treatment-related characteristics were recorded, and each miniscrew was followed until elective removal or failure.
Read the detailed description
Orthodontic miniscrews are widely used to provide temporary skeletal anchorage, yet the prognostic value of the insertion torque generated at placement remains uncertain. In this single-center prospective cohort, miniscrews placed for skeletal anchorage during routine fixed orthodontic treatment were followed under real-world clinical conditions. All miniscrews were placed by a single experienced operator following a standardized clinical protocol. Maximum clinical insertion torque was recorded at final seating using a calibrated manual disk-type torque wrench as the reference measurement, with a digital torque meter used for corroboration at sites with difficult access or when values exceeded the manual gauge range. Each miniscrew was monitored at routine orthodontic visits from placement until elective removal or failure, and its observation time was recorded. The study evaluates the association between maximum insertion torque and miniscrew outcome, accounting for the clustering of multiple miniscrews within patients, and describes insertion torque across anatomical insertion sites.
- Conditions
- Malocclusion
- Being tested
- microscrew
- Keywords
- mini-screw, skeletal anchorage, orthodontics, TADS, insertion torque
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microscrewDevice
Also called skeletal anchorage
measurement of microscrew insertion torque and its association with clinical success
What is being measured
The primary outcome is the main question the study is designed to answer.
MT success rate
A MT that provides the necessary orthodontic anchorage prior to its removal, or that its permanence in the mouth is ≥4 months, will be considered successful.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start7 Aug 2020
- Primary completion1 May 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Oyonarte, Universidad de los Andes, Chile
- Investigators
- rodrigo oyonarte, orthodontics, Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780149
- Sponsor's protocol ID
- MT Maximum insertion torque
- Acronym
- MTtorque
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximum Clinical Insertion Torque and Its Association With the Success Rate of Orthodontic Miniscrews
- ClinicalTrials.gov ID
- NCT07780149
- Acronym / sponsor ID
- MTtorque / MT Maximum insertion torque
- Conditions
- Malocclusion
- Keywords
- mini-screw, skeletal anchorage, orthodontics, TADS, insertion torque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Aug 2026 (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.
Orthodontic miniscrews provide temporary skeletal anchorage but are lost prematurely in a proportion of cases despite correct placement. The insertion torque generated when a miniscrew is seated has been proposed as a marker of primary stability, but its relationship with clinical success remains uncertain and the existing evidence is limited. This prospective observational cohort study evaluated orthodontic miniscrews placed for skeletal anchorage during routine fixed orthodontic treatment at the postgraduate orthodontic clinic of Universidad de los Andes, Santiago, Chile. The primary objective was to determine whether the maximum clinical insertion torque measured at placement is associated with miniscrew success. Maximum insertion torque and patient-, device-, site-, and treatment-related characteristics were recorded, and each miniscrew was followed until elective removal or failure.
Detailed description
Orthodontic miniscrews are widely used to provide temporary skeletal anchorage, yet the prognostic value of the insertion torque generated at placement remains uncertain. In this single-center prospective cohort, miniscrews placed for skeletal anchorage during routine fixed orthodontic treatment were followed under real-world clinical conditions. All miniscrews were placed by a single experienced operator following a standardized clinical protocol. Maximum clinical insertion torque was recorded at final seating using a calibrated manual disk-type torque wrench as the reference measurement, with a digital torque meter used for corroboration at sites with difficult access or when values exceeded the manual gauge range. Each miniscrew was monitored at routine orthodontic visits from placement until elective removal or failure, and its observation time was recorded. The study evaluates the association between maximum insertion torque and miniscrew outcome, accounting for the clustering of multiple miniscrews within patients, and describes insertion torque across anatomical insertion sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with indication for insertion of orthodontic mini-screws as an orthodontic anchorage device, attended at the Postgraduate Orthodontic Clinic of CESA, Universidad de los Andes, San Bernardo, Chile.
Key inclusion criteria (3 listed)
- - Patients undergoing orthodontic treatment and who have a clinical indication for skeletal anchorage using mini-screws.
- Patients who freely and voluntarily accept the procedure as part of their orthodontic treatment.
- Patients who freely and voluntarily consent or agree to the use of their TM installation and evolution data as part of their orthodontic treatment.
Key exclusion criteria (3 listed)
- - Patients with craniofacial syndromes.
- Patients with uncontrolled systemic disease.
- Patients with active periodontal disease.
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 |
|---|---|---|
| microscrewAlso: skeletal anchoragemeasurement of microscrew insertion torque and its association with clinical success | Device | – |
Primary outcome
MT success rate
Time frame: 1 year
A MT that provides the necessary orthodontic anchorage prior to its removal, or that its permanence in the mouth is ≥4 months, will be considered successful.
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 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
rodrigo oyonarte, orthodontics principal investigator
Universidad de los Andes, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Universidad de los Andes, Chile at 1 site in Chile.
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 3 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 21 Aug 2026. 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 Chile. 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?
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?
MT success rate (time frame: 1 year). 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 21 Aug 2026.