- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07780149
Maximum Clinical Insertion Torque and Its Association With the Success Rate of Orthodontic Miniscrews (MTtorque)
19. august 2026 opdateret af: Rodrigo Oyonarte, Universidad de los Andes, Chile
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
63
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile, vitacura
- Valentina Risso
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MT success rate
Tidsramme: 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.
|
1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: rodrigo oyonarte, orthodontics, Universidad de los Andes, Chile
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. august 2020
Primær færdiggørelse (Faktiske)
1. maj 2022
Studieafslutning (Faktiske)
1. september 2022
Datoer for studieregistrering
Først indsendt
17. marts 2022
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MT Maximum insertion torque
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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