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Orthodontic Appliance ComplicationNCT03653078

Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide

A study testing Three dimensional printed digital guide in people with Orthodontic Appliance Complication, run by Cairo University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Although mini screw insertion is considered as a simple and non-invasive technique, it's a critical procedure which requires precision and accuracy. The placement of mini-screw poses a challenge to the orthodontist, particularly if the space available for mini-screws is limited.4 The proximity to the vital structures… Read more about this study

Who is it for?
Ages 14 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Orthodontic Appliance Complication
What is being tested?
Three dimensional printed digital guide
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
15 Nov 2018to 15 Jan 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 14 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle

Who cannot join

  • Mixed dentition patients
  • Smoker patients
  • Patients with Increased lower facial height
  • Patients with missing posterior teeth
  • Bleeding disorders or anticoagulant therapy
  • Patients with cleft lip \& palate
  • Patients with facial asymmetry
  • Patients with transverse maxillary deficiency

Trial locations and contacts

No sites are listed yet.

Hadir Abo shady, MD contact

00201001937931

hadiraboshady@gmail.com

Mai Abo El fotouh, PHD contact

01001884499

maihamdi@gmail.com

About this study

Official title: Evaluation of Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide Versus Conventional Free Hand Placement Technique in Adult Orthodontic Patients A Split Mouth Randomized Clinical Trial

Although mini screw insertion is considered as a simple and non-invasive technique, it's a critical procedure which requires precision and accuracy. The placement of mini-screw poses a challenge to the orthodontist, particularly if the space available for mini-screws is limited.4 The proximity to the vital structures surrounding the proposed mini-screw position necessitates the precise knowledge of the anatomy of the insertion area.5 The incidence of mini-screw to tooth contact in the placement of inter-radicular region was 27%.6 Although failure of mini screw is considered a multi-factorial concern, many studies reported the proximity of a mini-screw to tooth structures is a major risk factor for failure, especially in the inter-radicular inserted mini-screws. guided insertion was believed to give more favorable results. Above all, the recent technology of the scanning and three-dimensional printing could pave the way to construct a simple accurate guide. Additionally all previous studies assessed the insertion accuracy using CBCT post-operatively, that can't be applied on human subjects for ethical reasons. Thus a non-invasive method for assessment of mini-screw insertion should be implemented.

Read the detailed description

PICOs P: Adult orthodontic patients need mini screws in maxillary arch bilaterally for anchorage I: Three dimensional printed digital guide for mini screw insertion C: Conventional free hand insertion technique

  • O: Primary outcome: Root proximity

Secondary outcomes:

  • Patient discomfort during insertion 17
  • Insertion accuracy
  • Angular deviation
  • Linear deviation
  • Failure 18 S: Split Mouth Randomized clinical Trial
Being tested
Three dimensional printed digital guide
Keywords
Surgical guide, Surgical stent, orthodontic mini screw, temporary anchorage device

What participants receive

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

  • Three dimensional printed digital guideDevice

    Also called surgical guide, surgical stent

    A CAD/CAM printed plate with a channel for mini-screw insertion

Study groups in NCT03653078
Study groupRoleWhat they receive
Three dimensional printed digital guideExperimentalone mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using Three dimensional printed digital guide, which is a device deisgned and printed through CAD/CAM technology, it's a printed plate fit on the teeth and buccal mucosa with a channel for mini- screw insertion, mini-screw will be inserted through the plate's channel
Receives: Device: Three dimensional printed digital guide
Conventional free hand insertionNo interventionone mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using conventional free hand insertion of mini-screw, which is a technique using the guiding anatomy for mini-screw insertion using the driver and the operator's skill.

What is being measured

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

  1. Root proximity

    Distance between inserted mini screw and the adjacent roots in microns

    Measured: immediately after mini-screw insertion (T0)

Secondary outcomes (1)

  1. Patient discomfort:

    Likert scale, it is scale divided into five points to measure the degree of patient discomfort maximum value(5) strongly discomfort, discomfort, neutral, little discomfort, and minimum value (0)no discomfort

    Measured: immediately after mini-screw insertion (T0)

Timeline

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

  1. First posted31 Aug 2018
  2. Study start15 Nov 2018 (estimated)
  3. Primary completion15 Dec 2019 (estimated)
  4. Study completion15 Jan 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
Model description
adult orthodontic participants
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03653078
Sponsor's protocol ID
CEBD-CU-2018-08-27
Status last verified
Aug 2018
First submitted
28 Aug 2018
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bae MJ, Kim JY, Park JT, Cha JY, Kim HJ, Yu HS, Hwang CJ. Accuracy of miniscrew surgical guides assessed from cone-beam computed tomography and digital models. Am J Orthod Dentofacial Orthop. 2013 Jun;143(6):893-901. doi: 10.1016/j.ajodo.2013.02.018.

    PubMed 23726340

  • Suzuki EY, Suzuki B. Accuracy of miniscrew implant placement with a 3-dimensional surgical guide. J Oral Maxillofac Surg. 2008 Jun;66(6):1245-52. doi: 10.1016/j.joms.2007.08.047.

    PubMed 18486791

Questions about this trial

What is this clinical trial studying?

A study testing Three dimensional printed digital guide in people with Orthodontic Appliance Complication, run by Cairo University.

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 1 inclusion and 8 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Hadir Abo shady, MD (00201001937931, hadiraboshady@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Root proximity (time frame: immediately after mini-screw insertion (T0)). 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 NCT03653078, which also lists 2 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 31 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.

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