Evidence-based Selection of Orthodontic Miniscrews, Increasing Their Success Rate in the Mandibular Buccal Shelf: A Randomized, Prospective Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Class III Malocclusion
- Sponsor
- Wroclaw Medical University
- Enrollment
- 100
- Primary Endpoint
- Assessing the presence of pain lasting longer than 48 hours after implantation.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Stability of the orthodontic miniscrews placed in the mandible is still considered to bare higher risk of failure compared to other intraoral locations. The aim of our study was to determine the influence of the miniscrew size on their long-term stability, occurrence of oral mucosa inflammation and pain lasting over 48 hours after implantation.
Investigators
Michał Sarul
Associate Professor
Wroclaw Medical University
Eligibility Criteria
Inclusion Criteria
- •generally healthy Caucasians
- •mild Class III maloclussion that required an absolute anchorage for en-masse distalization in the mandible
- •hypodivergent or normal angle between the maxillary and mandibular planes
- •excellent oral hygiene
Exclusion Criteria
- •Hyperdivergent angle between the maxillary and mandibular planes
- •unfavorable anatomical conditions - e.g. presence of a strong frenulum potentially irritating the miniscrew head during chewing and/or facial movement
Outcomes
Primary Outcomes
Assessing the presence of pain lasting longer than 48 hours after implantation.
Time Frame: two weeks
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
Assessing the presence of peri-implantitis
Time Frame: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
Assessing the stability of miniscrews
Time Frame: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
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.