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

August 10, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1008

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: 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
Time Frame: Immediately after implantation
Root perforation was diagnosed in CBCT performed after the procedure.
Immediately after implantation
Assesing the presence of microimplant fracture
Time Frame: During implantation
Microimplant fracture was diagnosed during implantation, reported by the clinician.
During implantation
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.
During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

May 14, 2024

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 12, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SUBZ.B190.24.005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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