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

NCT07761494 | Completed

• 1 other identifier: SUBZ.B190.24.005
• Study Type: interventional
• Target: 1,008
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malocclusion Class II

Keywords

skeletal anchorage; microscrews; orthodontic

Outcome Measures

Primary Outcomes (5)

• Assessing the presence of peri-implantitis

  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.

  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

  Root perforation was diagnosed in CBCT performed after the procedure.

  Immediately after implantation

• Assesing the presence of microimplant fracture

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

  During implantation

• Assessing the stability of miniscrews

  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.

Study Arms (2)

Insertion with self-drilling technique

EXPERIMENTAL

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

Insertion with self-tapping technique

EXPERIMENTAL

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

Interventions

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.

Insertion with self-drilling technique

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.

Insertion with self-tapping technique

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.

You may not qualify if:

• Smoking,
• Inadequate oral hygiene
• Chronic diseases (e.g. diabetes)
• Tooth loss

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 12, 2026
• Study Start: January 1, 2015
• Primary Completion: March 31, 2024
• Study Completion: May 14, 2024
• Last Updated: August 12, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share