Success Rate of the Miniscrews in the Mandibular Buccal Shelf
Not Applicable
Completed
- Conditions
- Class III Malocclusion
- Interventions
- Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelf
- 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
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
- Arm && Interventions
Group Intervention Description SH2018-10 miniscrew side Orthodontic miniscrew insertion in the mandibular buccal shelf 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. SH1514-08 miniscrew side Orthodontic miniscrew insertion in the mandibular buccal shelf 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.
- 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.
- Secondary Outcome Measures
Name Time Method