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OpenTrials
Completed

NCT Number: NCT07780149

Maximum Clinical Insertion Torque and Its Association With the Success Rate of Orthodontic Miniscrews

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Valentina Risso

Santiago, Santiago Metropolitan, vitacura, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

Exclusion criteria

  • - Patients with craniofacial syndromes.
  • Patients with uncontrolled systemic disease.
  • Patients with active periodontal disease.

Treatment and study plan

microscrew

Device

measurement of microscrew insertion torque and its association with clinical success

Other names: skeletal anchorage

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad de los Andes, Chile

Other

Registry information

Acronym: MTtorque

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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