- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07698730
Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides
7. juli 2026 opdateret af: Can Tho University of Medicine and Pharmacy
This randomized split-mouth clinical trial aims to compare the accuracy and clinical outcomes of CAD/CAM 3D-printed surgical guides with the conventional free-hand technique for orthodontic miniscrew placement in the posterior maxilla.
Each participant will receive miniscrew placement using both techniques on opposite sides of the maxilla following random allocation.
The primary outcome is placement accuracy assessed by three-dimensional positional and angular deviations between planned and actual miniscrew positions.
Secondary outcomes include miniscrew stability, success rate after three months, postoperative pain, procedural time, patient satisfaction, and complications.
The study also evaluates maxillary posterior cortical bone thickness using cone-beam computed tomography (CBCT) and investigates its relationship with miniscrew placement accuracy and stability
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Orthodontic miniscrews have become an effective source of temporary skeletal anchorage because they provide absolute anchorage with minimal dependence on patient compliance.
However, the success of orthodontic miniscrews largely depends on accurate insertion while avoiding adjacent anatomical structures, particularly dental roots and the maxillary sinus.
Incorrect placement may lead to root damage, instability, or failure of the miniscrew Cone-beam computed tomography (CBCT) allows three-dimensional evaluation of alveolar bone morphology and cortical bone thickness before miniscrew insertion.
Digital technologies combining CBCT, intraoral scanning, CAD/CAM planning, and three-dimensional printing have enabled fabrication of customized surgical guides designed to improve insertion accuracy This study is designed as a randomized split-mouth controlled clinical trial.
Patients requiring bilateral orthodontic miniscrews in the posterior maxilla will receive one miniscrew inserted using a CAD/CAM 3D-printed surgical guide and the contralateral miniscrew inserted using the conventional free-hand technique.
The side allocated to each intervention and the order of insertion will be randomized Placement accuracy will be evaluated by superimposing preoperative planning data with postoperative digital models using Geomagic Studio software.
Three-dimensional deviations, including coronal and apical positional deviations and angular deviations, will be calculated.
Miniscrew stability, success rate after three months, postoperative pain measured by the Visual Analog Scale (VAS), patient satisfaction, operative time, and treatment-related complications will also be evaluated.
Additionally, CBCT will be used to measure cortical bone thickness at multiple posterior maxillary interradicular sites, and correlations between cortical bone thickness and miniscrew accuracy and stability will be analyzed
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
33
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Can Tho, Vietnam, +84
- Can Tho University of Medicine and Pharmacy
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients requiring bilateral orthodontic miniscrew placement in the posterior maxilla as part of orthodontic treatment.
- Availability of high-quality cone-beam computed tomography (CBCT) images suitable for evaluation and digital planning.
- Good general health and ability to undergo orthodontic treatment.
- Healthy periodontal tissues at the planned miniscrew insertion sites.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Systemic diseases or medications affecting bone healing or bone metabolism.
- Bleeding disorders or contraindications to minor oral surgery.
- Active periodontal disease or local infection at the planned insertion site.
- Poor-quality or incomplete CBCT images.
- Contraindications to CBCT imaging.
- Pregnancy or lactation.
- Previous orthodontic miniscrew placement in the planned insertion area.
- Refusal or inability to provide informed consent.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: CAD/CAM-Guided Miniscrew Placement
Miniscrew placement using a customized CAD/CAM 3D-printed surgical guide.
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A customized tooth-supported CAD/CAM-designed and 3D-printed surgical guide fabricated from CBCT and intraoral scan data to assist accurate orthodontic miniscrew insertion in the posterior maxilla according to the preoperative digital treatment plan.
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Aktiv komparator: Free-Hand Miniscrew Placement
Conventional free-hand orthodontic miniscrew placement.
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Orthodontic miniscrews are inserted manually using the conventional free-hand technique without the assistance of a surgical guide, based on the clinician's clinical judgment and anatomical landmarks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Accuracy of Orthodontic Miniscrew Placement
Tidsramme: Immediately after miniscrew placement
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Placement accuracy will be assessed by comparing the planned and actual miniscrew positions using digital superimposition.
Coronal and apical three-dimensional deviations together with angular deviations will be calculated using Geomagic Studio software.
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Immediately after miniscrew placement
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Miniscrew Success Rate
Tidsramme: 3 months
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Clinical success defined as stable miniscrews remaining functional for orthodontic anchorage.
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3 months
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Miniscrew Stability
Tidsramme: Immediately after insertion, 1 week, 1 month, and 3 months.
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Clinical assessment of miniscrew stability after insertion.
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Immediately after insertion, 1 week, 1 month, and 3 months.
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Three-Dimensional Miniscrew Displacement
Tidsramme: 3 months.
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Changes in miniscrew position between immediate postoperative and 3-month evaluations
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3 months.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lam Nguyen Le, Assoc. Prof., Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
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)
1. november 2025
Primær færdiggørelse (Faktiske)
1. juni 2026
Studieafslutning (Faktiske)
1. juni 2026
Datoer for studieregistrering
Først indsendt
7. juli 2026
Først indsendt, der opfyldte QC-kriterier
7. juli 2026
Først opslået (Faktiske)
13. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- LeNguyenLam
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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