Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition
10. august 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
1008
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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:
|
|
Eksperimentell: 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:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessing the presence of peri-implantitis
Tidsramme: 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.
Tidsramme: 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
Tidsramme: Immediately after implantation
|
Root perforation was diagnosed in CBCT performed after the procedure.
|
Immediately after implantation
|
|
Assesing the presence of microimplant fracture
Tidsramme: During implantation
|
Microimplant fracture was diagnosed during implantation, reported by the clinician.
|
During implantation
|
|
Assessing the stability of miniscrews
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2015
Primær fullføring (Faktiske)
31. mars 2024
Studiet fullført (Faktiske)
14. mai 2024
Datoer for studieregistrering
Først innsendt
21. juli 2026
Først innsendt som oppfylte QC-kriteriene
10. august 2026
Først lagt ut (Faktiske)
12. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2026
Sist bekreftet
1. juni 2024
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- SUBZ.B190.24.005
Plan for individuelle deltakerdata (IPD)
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NEI
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