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Orthodontic Appliance ComplicationNCT03696511

Miniscrews Primary Stability

A study testing Orthodontic miniscrew insertion in people with Orthodontic Appliance Complication, run by University of Genova at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 70 years
Conditions the study is for
Orthodontic Appliance Complication
What is being tested?
Orthodontic miniscrew insertion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesin 2 countries
Study dates
29 Sep 2018to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • patient who need ortho treatment with miniscrew
  • permanent dentition

Who cannot join

  • bone pathologies
  • systemic disease

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Italy2 sites

  • Orthodontic Departments

    Brescia, 25121

  • Orthodontic Department

    Genova, 16100

Other trials in Italy

Spain1 site

  • Universidad Alfonso X El Sabio (UAX)

    Madrid

Other trials in Spain

About this study

Official title: Multicentric Clinical Study Protocol on Primary Stability of STORM® Miniscrew

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.

Read the 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.

Being tested
Orthodontic miniscrew insertion
Keywords
Miniscrew

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orthodontic miniscrew insertionDevice

    orthodontic treatment using miniscrews as anchorage reinforcement

Study groups in NCT03696511
Study groupRoleWhat they receive
group 1:maxillary insertionActive comparatorOrthodontic miniscrew insertion; maxillary insertion. buccal
Receives: Device: Orthodontic miniscrew insertion
group 2: mandible insertionActive comparatorOrthodontic miniscrew insertion; mandible insertion.
Receives: Device: Orthodontic miniscrew insertion
group 3: palatal insertionActive comparatorOrthodontic miniscrew insertion; palatal insertion
Receives: Device: Orthodontic miniscrew insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success

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

    Measured: 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)

  1. MIT

    miniscrew maximum insertion torque: The moment when the screw will be placed, the maximum insertion torque will be registered at the insertion time, with a analogical screwdriver, measured in Ncm

    Measured: 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

  2. MRT

    maximum removal torque. Maximum removal torque will be recorded using an analogical screwdriver at the completion of screw insertion. MRT is a unique value expressed in Ncm measured when the screws will be removed.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2018
  2. Study start29 Sep 2018
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696511
Sponsor's protocol ID
GE-BS-MA MRCT
Status last verified
Oct 2018
First submitted
18 Jul 2018
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29482179

  • 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.

    PubMed 28962732

  • 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.

    PubMed 25192157

  • 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.

    PubMed 23311659

  • 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.

    PubMed 26728036

Questions about this trial

What is this clinical trial studying?

A study testing Orthodontic miniscrew insertion in people with Orthodontic Appliance Complication, run by University of Genova at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696511, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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