Miniscrews Primary Stability

NCT03696511 | Unknown

• 1 other identifier: GE-BS-MA MRCT
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

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.

Conditions

Orthodontic Appliance Complication

Keywords

Miniscrew

Outcome Measures

Primary Outcomes (1)

• Success

  How many screws don't fail. Success if the screw remain stable until the end of biomechanics applied.

  From the moment the screw will be placed, measuring maximum insertion torque, through study completion, when the screws will be removed, measuring removal torque. An average duration of screw of 10-12 months is expected.

Secondary Outcomes (2)

• MIT

  The date when, for each patient, the miniscrew will be inserted. Registered as the insertion date (day). Up to 12 months from orthodontic therapy beginning. The event is determined from date of randomization list creation until the day of screw insertion

• MRT

  The date when, for each patient,the miniscrew will be removed.Registered as the removal date (day).Up to 24 months after miniscrew insertion.The event is determined from date of randomization list creation until the day of screw removal, up to 48 months

Other Outcomes (2)

• Cortical thickness

  At the beginning of the orthodontic treatment, before any dental movement occurred. Time frame is from randomization list and beginning of orthodontic treatment, up to 24 months.

• Marrow bone density

  At the beginning of the orthodontic treatment, before any dental movement occurred. Time frame is from randomization list and beginning of orthodontic treatment, up to 24 months.

Study Arms (3)

group 1:maxillary insertion

ACTIVE COMPARATOR

Orthodontic miniscrew insertion; maxillary insertion. buccal

Device: Orthodontic miniscrew insertion

group 2: mandible insertion

ACTIVE COMPARATOR

Orthodontic miniscrew insertion; mandible insertion.

Device: Orthodontic miniscrew insertion

group 3: palatal insertion

ACTIVE COMPARATOR

Orthodontic miniscrew insertion; palatal insertion

Device: Orthodontic miniscrew insertion

Interventions

Orthodontic miniscrew insertion DEVICE

orthodontic treatment using miniscrews as anchorage reinforcement

group 1:maxillary insertion; group 2: mandible insertion; group 3: palatal insertion

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patient who need ortho treatment with miniscrew
• permanent dentition

You may not qualify if:

• bone pathologies
• systemic disease

Sponsors & Collaborators

• University of Genova: lead
• Università degli Studi di Brescia: collaborator
• Alfonso X El Sabio University: collaborator

Study Sites (3)

Orthodontic Departments

Brescia, 25121, Italy

Location

Orthodontic Department

Genova, 16100, Italy

Location

Universidad Alfonso X El Sabio (UAX)

Madrid, Spain

Location

Related Publications (5)

• 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.

  PMID: 29482179 RESULT

• 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.

  PMID: 28962732 RESULT

• 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.

  PMID: 25192157 RESULT

• 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.

  PMID: 23311659 RESULT

• 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.

  PMID: 26728036 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: data sheet will be blinded for the analyses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: October 4, 2018
• Study Start: September 29, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 7, 2019

Record last verified: 2018-10

Locations

IT (2); ES (1)