Miniscrews Primary Stability

NCT ID: NCT03696511

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-29
• Study Completion Date: 2020-12-30

Brief Summary

Orthodontic Miniscrew primary stability is essential for success and long term results.

The aim of the present study is to evaluate Bone Properties and Torque insertion values and how they could be related to primary stability and success rate of miniscrew.

Detailed Description

Orthodontic miniscrews are intraoral anchorage devices designed to support biomechanics during orthodontic tooth movement. Also known as miniscrews, mini-implants, microscrews, or temporary anchorage devices, they are made of a head, a neck, and a threaded shank. The head may show different designs (bracket-like, rounded with slot, etc.) the threaded shank is generally cylindrical, tapered or a combination of the two, and may be self-tapping (i.e. requiring a pre-drilled pilot hole) and/or self-drilling (not requiring a pilot hole). Because of their small diameter, they may be implanted in a wide variety of anatomic sites, such as the alveolar interradicular spaces or the palatal cortical bone, in order to attend to treatment anchorage needs. The loading protocol for miniscrews loading can be as immediate as delayed; in the beginning in literature was indicated a non-specific period of healing and osseointegration before a screw inserted in the mandible could be loaded; the importance of a healing period was derived by several studies on Branemark protocol on implants. Further experimental studies on orthodontic load were not able to demonstrate loaded implant loosening, even when loads were applied immediately, so that an immediate loading protocol for orthodontic miniscrews appeared as reasonable. Costa and Melsen studied the tissue reaction around the immediately loaded screws in an animal model and suggested the use of immediately loaded screws as an intra-oral extra-dental anchorage. Histomorphometric analyses have shown that the immediate loading of miniscrew implants may help to activate bone remodeling and increase the mineral contents at the loaded region. Compared to traditional endosseous implants, orthodontic miniscrews have relatively high failure rates, varying from 16.4% to 39% ; according to recent reviews, the average failure rate is believed to be less than 20%. Many factors have been proposed to be associated to success rate; among these age, gender, jaw (maxilla or mandible), placement site, tissue mobility (firm or movable tissue), inflammation, distance to the root, insertion torque, loading time, type, length, and diameter of the miniscrew. Recently, an experimental study on primary stability found that bone properties are more important than the screw geometry in establishing primary mechanical retention. Thus the aim of this study is to deeply analyze the bone role related to the success of miniscrews analyzing both insertion/removal torque values, both bone characteristics by the mean of x-rays.

Conditions

Orthodontic Appliance Complication

Study Design

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

Study Groups

group 1:maxillary insertion

Orthodontic miniscrew insertion; maxillary insertion. buccal

Group Type: ACTIVE_COMPARATOR

Orthodontic miniscrew insertion

Intervention Type: DEVICE

orthodontic treatment using miniscrews as anchorage reinforcement

group 2: mandible insertion

Orthodontic miniscrew insertion; mandible insertion.

Group Type: ACTIVE_COMPARATOR

Orthodontic miniscrew insertion

Intervention Type: DEVICE

orthodontic treatment using miniscrews as anchorage reinforcement

group 3: palatal insertion

Orthodontic miniscrew insertion; palatal insertion

Group Type: ACTIVE_COMPARATOR

Orthodontic miniscrew insertion

Intervention Type: DEVICE

orthodontic treatment using miniscrews as anchorage reinforcement

Interventions

Orthodontic miniscrew insertion

orthodontic treatment using miniscrews as anchorage reinforcement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patient who need ortho treatment with miniscrew
• permanent dentition

Exclusion Criteria

• bone pathologies
• systemic disease

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: collaborator

Alfonso X El Sabio University

OTHER

Sponsor Role: collaborator

University of Genova

OTHER

Sponsor Role: lead

Responsible Party

Marco Migliorati

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Orthodontic Departments

Brescia, , Italy

Orthodontic Department

Genova, , Italy

Universidad Alfonso X El Sabio (UAX)

Madrid, , Spain

Countries

Italy; Spain

References

Migliorati M, Drago S, Dalessandri D, Lagazzo A, Gallo F, Capurro M, Silvestrini-Biavati A. On the stability efficiency of anchorage self-tapping screws: Ex vivo experiments on miniscrew implants used in orthodontics. J Mech Behav Biomed Mater. 2018 May;81:46-51. doi: 10.1016/j.jmbbm.2018.02.019. Epub 2018 Feb 19.

Reference Type: RESULT

PMID: 29482179 (View on PubMed)

Watanabe T, Miyazawa K, Fujiwara T, Kawaguchi M, Tabuchi M, Goto S. Insertion torque and Periotest values are important factors predicting outcome after orthodontic miniscrew placement. Am J Orthod Dentofacial Orthop. 2017 Oct;152(4):483-488. doi: 10.1016/j.ajodo.2017.01.026.

Reference Type: RESULT

PMID: 28962732 (View on PubMed)

Inoue M, Kuroda S, Yasue A, Horiuchi S, Kyung HM, Tanaka E. Torque ratio as a predictable factor on primary stability of orthodontic miniscrew implants. Implant Dent. 2014 Oct;23(5):576-81. doi: 10.1097/ID.0000000000000138.

Reference Type: RESULT

PMID: 25192157 (View on PubMed)

Watanabe H, Deguchi T, Hasegawa M, Ito M, Kim S, Takano-Yamamoto T. Orthodontic miniscrew failure rate and root proximity, insertion angle, bone contact length, and bone density. Orthod Craniofac Res. 2013 Feb;16(1):44-55. doi: 10.1111/ocr.12003. Epub 2012 Sep 3.

Reference Type: RESULT

PMID: 23311659 (View on PubMed)

Migliorati M, Drago S, Gallo F, Amorfini L, Dalessandri D, Calzolari C, Benedicenti S, Silvestrini-Biavati A. Immediate versus delayed loading: comparison of primary stability loss after miniscrew placement in orthodontic patients-a single-centre blinded randomized clinical trial. Eur J Orthod. 2016 Dec;38(6):652-659. doi: 10.1093/ejo/cjv095. Epub 2016 Jan 4.

Reference Type: RESULT

PMID: 26728036 (View on PubMed)

Other Identifiers

GE-BS-MA MRCT

Identifier Type: -

Identifier Source: org_study_id