Success Rate of the Miniscrews in the Mandibular Buccal Shelf

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthodontic miniscrew insertion in the mandibular buccal shelf

Procedure

Each patient received miniscrews in both sizes. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed in the mandibular buccal shelf, laterally to the first and second molar interproximal area, with angulation 30 degree to the bone surface, meaning that miniscrew angulation should be approximately the same as the axial inclination of the adjacent molar. Miniscrews were loaded with orthodontic force 2 weeks after the surgery. The investigated factors were:

long-term success rate of the miniscrews in the buccal shelf of the mandible (miniscrews were considered long-term stable if they served as an anchorage until completion of mandibular distalization, at least 9 months);
peri-implantitis development (enlargement of the gingiva and/or redness and/or tendency to bleed);
the patient's report of pain lasting longer than 48 hours after miniscrew insertion.

Primary outcomes

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.
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 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.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Evidence-based Selection of Orthodontic Miniscrews, Increasing Their Success Rate in the Mandibular Buccal Shelf: A Randomized, Prospective Clinical Trial

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Mar 15, 2022
Registry last updated: Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed