Success Rate of the Miniscrews in the Mandibular Buccal Shelf

Wroclaw Medical University

Status: Completed

Conditions: Class III Malocclusion

Treatments: Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelf

Study type: Interventional

Funder types: Other

Identifiers

NCT05280678

293/2007

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

SH2018-10 miniscrew side

Experimental group

Description:

We designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews, randomly assigned to either left or right side. To do so, our nurse divided both miniscrew types into two halves and assigned symbols appropriate for blinding the intervention. Thus, two combinations of miniscrew sets aroused: 1. SH1514-08R and SH2018-10L or 2. SH1514-08L and SH2018-10R, which were placed separately in opaque packages marked consecutively from "1" to "100" and stored on the tray with dividers. One hundred cards, labeled accordingly, were placed in an envelope, from which the nurse blindly pulled the card just before the miniscrew insertion, this way assigning the set number to every patient. Thus both: the placement side and the screw size were random for clinician.

Treatment:

Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelf

SH1514-08 miniscrew side

Experimental group

Description:

We designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews, randomly assigned to either left or right side. To do so, our nurse divided both miniscrew types into two halves and assigned symbols appropriate for blinding the intervention. Thus, two combinations of miniscrew sets aroused: 1. SH1514-08R and SH2018-10L or 2. SH1514-08L and SH2018-10R, which were placed separately in opaque packages marked consecutively from "1" to "100" and stored on the tray with dividers. One hundred cards, labeled accordingly, were placed in an envelope, from which the nurse blindly pulled the card just before the miniscrew insertion, this way assigning the set number to every patient. Thus both: the placement side and the screw size were random for clinician.

Treatment:

Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelf