Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition
10. August 2026 aktualisiert von: Wroclaw Medical University
Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study
Evidence for the undeniable role of microscrews in anchorage control, as well as their other advantages, such as ease of insertion and removal techniques, have led to their routine use in orthodontics.
Treatment with microscrews, despite its obvious advantages, is associated with the risk of complications, the etiology of which is multifactorial.
Identifying (and subsequently controlling) as many of them as possible through research constitutes an ongoing challenge for scientists.
This pursuit defined the purpose of the present study: to determine whether a type of TISAD insertion technique - self-drilling or self-tapping - as well as the patient's sex and maxillary quadrant constitute predisposing factors for the occurrence of certain complications.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
1008
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.
Exclusion Criteria:
- Smoking,
- Inadequate oral hygiene
- Chronic diseases (e.g. diabetes)
- Tooth loss
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Insertion with self-drilling technique
Each patient received two microimplants both using self- drilling method.
In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
|
Patients received 2 miniscrews using self-drilling method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated complications were:
|
|
Experimental: Insertion with self-tapping technique
Each patient received two microimplants both using self-tapping method.
In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant.
|
Patients received 2 miniscrews using self-tapping method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated factors were:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Assessing the presence of peri-implantitis
Zeitfenster: The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
|
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
|
The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
|
|
Assessing the presence of pain lasting longer than 48 hours after implantation.
Zeitfenster: 2 weeks after implantation
|
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
|
2 weeks after implantation
|
|
Assessing the presence of root perforation
Zeitfenster: Immediately after implantation
|
Root perforation was diagnosed in CBCT performed after the procedure.
|
Immediately after implantation
|
|
Assesing the presence of microimplant fracture
Zeitfenster: During implantation
|
Microimplant fracture was diagnosed during implantation, reported by the clinician.
|
During implantation
|
|
Assessing the stability of miniscrews
Zeitfenster: During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
|
The mobility of the miniscrews was checked clinically with cotton tweezers at each visit.
Miniscrews that could not sustain orthodontic force and required replacement because of mobility were considered failures.
|
During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2015
Primärer Abschluss (Tatsächlich)
31. März 2024
Studienabschluss (Tatsächlich)
14. Mai 2024
Studienanmeldedaten
Zuerst eingereicht
21. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. August 2026
Zuerst gepostet (Tatsächlich)
12. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. August 2026
Zuletzt verifiziert
1. Juni 2024
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- SUBZ.B190.24.005
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .