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Completed

NCT Number: NCT07761494

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

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.

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Key information

Conditions

Malocclusion Class II

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthodontic miniscrew insertion using self-drilling method

Procedure

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.

Orthodontic miniscrew insertion using self-tapping method

Procedure

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.

Primary outcomes

  1. Assessing the presence of peri-implantitis

    Time frame: 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.

  2. Assessing the presence of pain lasting longer than 48 hours after implantation.

    Time frame: 2 weeks after implantation

    Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.

  3. Assessing the presence of root perforation

    Time frame: Immediately after implantation

    Root perforation was diagnosed in CBCT performed after the procedure.

  4. Assesing the presence of microimplant fracture

    Time frame: During implantation

    Microimplant fracture was diagnosed during implantation, reported by the clinician.

  5. Assessing the stability of miniscrews

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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