Success Rate of the Miniscrews in the Mandibular Buccal Shelf

Class III Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280678
• Other study ID #: 293/2007
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: March 2022
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Procedure:
• Orthodontic miniscrew insertion in the mandibular buccal shelf
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).
Primary	Assessing the presence of peri-implantitis	Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.	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).
Primary	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.	two weeks