Success Rate of the Miniscrews in the Mandibular Buccal Shelf

NCT ID: NCT05280678

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-31

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.

Conditions

Class III Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SH2018-10 miniscrew side

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.

Group Type: EXPERIMENTAL

Orthodontic miniscrew insertion in the mandibular buccal shelf

Intervention Type: 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.

SH1514-08 miniscrew side

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.

Group Type: EXPERIMENTAL

Orthodontic miniscrew insertion in the mandibular buccal shelf

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Michał Sarul

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michał Sarul

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

References

Sarul M, Lis J, Park HS, Rumin K. Evidence-based selection of orthodontic miniscrews, increasing their success rate in the mandibular buccal shelf. A randomized, prospective clinical trial. BMC Oral Health. 2022 Sep 20;22(1):414. doi: 10.1186/s12903-022-02460-3.

Reference Type: DERIVED

PMID: 36127718 (View on PubMed)

Other Identifiers

293/2007

Identifier Type: -

Identifier Source: org_study_id