Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,008
- Primary Endpoint
- Assessing the presence of peri-implantitis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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
- •Inadequate oral hygiene
- •Chronic diseases (e.g. diabetes)
- •Tooth loss
Arms & Interventions
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.
Intervention: Orthodontic miniscrew insertion using self-drilling method (Procedure)
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.
Intervention: Orthodontic miniscrew insertion using self-tapping method (Procedure)
Outcomes
Primary Outcomes
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.
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.
Assessing the presence of root perforation
Time Frame: Immediately after implantation
Root perforation was diagnosed in CBCT performed after the procedure.
Assesing the presence of microimplant fracture
Time Frame: During implantation
Microimplant fracture was diagnosed during implantation, reported by the clinician.
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.
Secondary Outcomes
No secondary outcomes reported