GuideMiaGuideMia Technologies, LLC
OrthoPlus 工作流程

开始之前

Intended use and safety

What GuideMia OrthoPlus is and produces, its indications for use, intended users, warnings, and the boundary between what the system does and what remains the clinician's judgement.

What GuideMia OrthoPlus is

GuideMia OrthoPlus is a Windows desktop application for orthodontic treatment planning and appliance design. It takes intra-oral scans — and, where you have one, a CBCT volume — separates the individual teeth, produces a treatment plan, stages the movement into steps, and writes out files you can manufacture from.

Everything happens in one program, on your own machine, in one project file. There is no separate module to launch, no intermediate file to hand between tools, and no second application to install. Segmentation, planning, staging, attachments, model generation and reporting are all pages of the same workflow, and the case carries all of them. If you have the case open, you have everything open.

Projects are saved with the extension .gos; a packaged project, the form you send to someone else, is .gos.gpk.

What the software produces:

OutputUsed for
Arch models, one per stepPrinting, then thermoforming aligners over
Aligner and retainer shellsPrinting directly, no thermoforming
Aligner boundary filesReviewing and adjusting the cut line of each shell
Aligner trimming pathsDriving a robotic trimmer
Bracket bonding guidesIndirect bonding of fixed appliances
A combined model of teeth, gums and attachmentsVisualisation and case sharing
A treatment reportPresenting the plan

Two strengths are worth knowing about before you begin, because they change how you work. The first is that automation is offered at every stage rather than in one place: the Happy Button described in step 1 will do the next step of the workflow for you at any point, and AlignerBot will run a whole case end to end. The second is that everything runs on your own machine. Cases are not uploaded for processing, and the AI Engine that performs segmentation is a local program.

Indications for use

"GuideMia Ortho+ software system is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design option (Custom metal bands, export of models, Indirect Bonding) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of treatment. It can be further used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives."

Use of the system requires the necessary domain training and knowledge in the practice of orthodontics, as well as dedicated training in the use of the software.

Intended users

The system is for dental professionals in dental offices, dental laboratories and treatment planning centres. In practice one person usually runs a whole case, but the responsibilities divide roughly three ways:

  • Dentists, oral surgeons and physicians — diagnosis tools, treatment plan review and adjustment, guide review, plan approval.
  • Planners — data preparation, treatment planning, and model design.
  • General — all system functions.

Contraindications

No specific contraindications are related to the use of the software system. It is the clinician's responsibility to assess whether specific treatment planning decisions — tooth movements, extractions, interproximal reduction — can be carried out in practice during treatment.

Warnings

The software does not check whether a planned movement is achievable in a patient. It does not attempt to determine whether any tooth movement, or combination of movements, that it shows you can actually be implemented in real life. A movement that the software visualises may not be possible; a visualisation may be inaccurate, in that the same movement implemented in a patient might produce more or different effects than the simulation shows. The software also contains no functionality attempting to check whether an attempt to implement a movement might cause damage — to the teeth or to the jaw.

Any treatment attempt to implement a movement or manipulation visualised by the software should be planned and carried out only by an orthodontic professional who has assessed, with due diligence, whether it can be implemented without causing damage to the patient. The risks of any such treatment attempt are assumed entirely by the person carrying out the treatment. GuideMia Technologies, LLC disclaims any and all liability for the results of treatment attempts made on the basis of visualisations generated within the software.

Collisions are not guaranteed to be absent. There is no guarantee that a plan of movements will avoid collisions between teeth over the treatment course. Automatic movement planning produces paths that theoretically do not collide, but collisions can still occur in treatment for reasons including the materials used and the patient's compliance with instructions.

Scanning protocol. The software can only be used when patients have been scanned according to specific protocols and procedures, and where study models have been made and scanned if necessary.

Training. Orthodontic treatment planning should be performed only by practitioners or lab technicians trained to do so. Necessary training includes orthodontics, CT imaging concepts, and GuideMia training. Adequate studies should be performed to examine the anatomic structures and to assess the biomechanical, functional and aesthetic requirements of each case. Radiographs or other diagnostic reviews should be performed to determine the position and topography of the maxillary sinus, nasal cavities, inferior alveolar nerve, mental foramen, natural tooth positions and other anatomical features that may affect orthodontic treatment. Consultation between the orthodontist and the dental laboratory is essential for success.

Caution

Use of this device is restricted to, or by the order of, licensed physicians or dentists, and per prescriptions of licensed physicians or dentists.

What the system does, and what it does not do

Every capability below has a boundary, and the boundary is the part worth reading. The guidance in this column is the manufacturer's, not this guide's.

The system doesThe system does not
Manage case data — scans, segmentation, plans and designs — in one projectProvide a database, guarantee the integrity or accessibility of project data, or provide backup and restore. Backing up your cases is your own arrangement
Provide inspection and diagnostic tools: 2D and 3D visualisation, thresholding and rendering, snapshots and bookmarks, case review commentsIdentify potential pathological problems, or analyse whether a case can be treated. The clinician is completely responsible for diagnosis and treatment evaluation
Provide analysis: measurement, distance maps, tooth metrics, movement figures, interproximal reduction requirements, collision detectionGuarantee that actual movement in treatment will follow what was simulated. Real movement depends on mechanical and biological factors and on compliance
Segment teeth, register optical and CT data, define the plan, stage the movement and simulate itGive the soft-tissue morphing any biological basis. It is for viewing, not for clinical judgement — treat morphed tissue with caution
Check each tooth's movement against a maximum per-step limit — 0.2 mm for translation to begin with, and editable in the movement profile (step 9)Establish that a planned movement is possible or advisable. Orthodontic expertise is needed to evaluate the biology and mechanics of the case
Generate arch models with attachments, as a series representing movement from initial to final positionsAssume any particular anchorage or tooth-moving mechanism (see below)
Generate arch models for thermoforming aligners with approved materialsRecommend CNC milling of arch models, bonding guides or aligners. None of the exported models are expected to be CAD/CAM milled

Two specific pieces of manufacturing guidance are worth lifting out of that table, because they affect what you do after the files leave the software:

  • Trim aligners to the tooth emerging curve, or to a minimum tissue area of no more than 3 mm. This follows from the soft-tissue morphing having no biomedical basis, and it is the practical limit on how far a thermoformed aligner should extend onto tissue.
  • Do not mill. Neither arch models nor aligners are intended to be produced on a CNC milling machine.

Anchorage, and what simulation assumes

The product is intended for treatment planning and simulation. Designing and fabricating an appliance depends on domain knowledge and design work beyond the simulation itself.

The movement simulation does not assume the existence or the design of the anchorage and tooth-moving mechanisms that would deliver the movement. Appliance design has to supply that. It follows that a simulation from this software is not, on its own, intended for significant movements — large translations, for example — without additional anchorage design and an applicable tooth-moving technology in the appliance concerned.

Even with anchorage designed in, take additional scans during treatment and re-evaluate the course and the plan against them. Step 11 covers restarting a case from a mid-treatment scan, which is a designed workflow rather than a workaround.