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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07761494
Enrollment
1008
Registered
2026-08-12
Start date
2015-01-01
Completion date
2024-05-14
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion Class II

Keywords

skeletal anchorage, microscrews, orthodontic

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.

Interventions

PROCEDUREOrthodontic 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.

PROCEDUREOrthodontic 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.

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessing the presence of peri-implantitisThe 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.
Assessing the presence of pain lasting longer than 48 hours after implantation.2 weeks after implantationTwo weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
Assessing the presence of root perforationImmediately after implantationRoot perforation was diagnosed in CBCT performed after the procedure.
Assesing the presence of microimplant fractureDuring implantationMicroimplant fracture was diagnosed during implantation, reported by the clinician.
Assessing the stability of miniscrewsDuring 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026