Success Rate of the Miniscrews in the Mandibular Buccal Shelf

Not Applicable

Completed

• Conditions: Class III Malocclusion

• Registration Number: NCT05280678
• Lead Sponsor: Wroclaw Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Study First Submitted: 2022-01-10
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-05
• Last Update Submitted: 2022-03-05
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessing the presence of pain lasting longer than 48 hours after implantation.	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	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	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.