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Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition

10 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

1008

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: Orthodontic miniscrew insertion using self-drilling method

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:

  • peri-implantitis development ;
  • the patient's report of pain lasting longer than 48 hours after miniscrew insertion.
  • occurence of rooth perforation diagnosed in CBCT performed after procedure
  • occurence of microimplant fracture during procedure
  • microimplant failure recorded during subsequent follow-up visits.
Experimentell: 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.
Procedur: Orthodontic miniscrew insertion using self-tapping method

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:

  • peri-implantitis development ;
  • the patient's report of pain lasting longer than 48 hours after miniscrew -insertion.
  • occurence of rooth perforation diagnosed in CBCT performed after procedure
  • occurence of microimplant fracture during procedure microimplant failure recorded during subsequent follow-up visits.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assessing the presence of peri-implantitis
Tidsram: 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.
Tidsram: 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
Tidsram: Immediately after implantation
Root perforation was diagnosed in CBCT performed after the procedure.
Immediately after implantation
Assesing the presence of microimplant fracture
Tidsram: During implantation
Microimplant fracture was diagnosed during implantation, reported by the clinician.
During implantation
Assessing the stability of miniscrews
Tidsram: 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.

Samarbetspartners och utredare

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Sponsor

Wroclaw Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2015

Primärt slutförande (Faktisk)

31 mars 2024

Avslutad studie (Faktisk)

14 maj 2024

Studieregistreringsdatum

Först inskickad

21 juli 2026

Först inskickad som uppfyllde QC-kriterierna

10 augusti 2026

Första postat (Faktisk)

12 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 augusti 2026

Senast verifierad

1 juni 2024

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • SUBZ.B190.24.005

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