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

Wroclaw Medical University1,008 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,008

Conditions

Malocclusion Class II

Interventions

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 methodPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Assessing the presence of peri-implantitis

Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.

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).

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.

Time frame: 2 weeks after implantation

Assessing the presence of root perforation

Root perforation was diagnosed in CBCT performed after the procedure.

Time frame: Immediately after implantation

Assesing the presence of microimplant fracture

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

Time frame: 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.

Time frame: During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.