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COMPLETED
NCT07761494
NA

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

Sponsor: Wroclaw Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

1008

Start Date

2015-01-01

Completion Date

2024-05-14

Last Updated

2026-08-12

Healthy Volunteers

Yes

Interventions

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.

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.