Softening Thermodynamic 3D-Printed Night Guard IFU

The device is made of biocompatible materials and is custom-made for each patient using 3D printing technology. The nightguard fits comfortably over the upper or lower teeth and provides cushioning to protect against damage caused by bruxism.

Indications for Use

Softening Thermodynamic 3D-Printed Nightguards

The Hard/Soft 3D-Printed Nightguard is a dental device that protects teeth from nighttime grinding and clenching.

Contraindication

Patients with loose or damaged teeth or those with temporomandibular joint disorder (TMD) should not use the device without first consulting a dental professional.

Potential Risks and Benefits of Softening Thermodynamic 3D-Printed Nightguards

Advise patients of the following:

The benefits of using the Softening Thermodynamic 3D-Printed Nightguard include protection against tooth damage and relief from associated discomfort. The potential risks include mouth or tooth soreness, which should resolve after a few days of use.

Directions for Use

To ensure proper use of the nightguard, dental professionals and patients should follow these steps:

  • Wash your hands before handling the nightguard.
  • Place the nightguard over the upper or lower teeth as the dentist instructs.
  • Bite down gently to ensure a comfortable fit.
  • Remove the nightguard in the morning and rinse with warm water.

Seating the Splint

 

The 3D-printed night guard contains softening thermodynamic properties. Heat the splint under hot water for 20–30 seconds before placing it on your patient’s teeth. Doing this adds flexibility, allowing for a comfortable fit with minimal to no adjustments.

Adjustment recommendations

  • Operate the bur at high speed, applying minimal pressure while using water.
    • It's important to maintain the temperature using water and air spray. This method helps prevent the formation of micro-fractures. A fine-grit diamond is advisable for adjustments, and air-only handpiece adjustments are not recommended.
    • For shaping different surfaces, specific tools are best:
      •  A football-shaped bur is effective for the occlusal and lingual surfaces, especially on anterior teeth 
      • A tapered bur is better suited for the buccal and lingual surfaces.

Cleaning instructions

To clean the nightguard, patients should follow these steps:

 

Dandy recommends cleaning your device daily before and after every use. Immediately after removal, use warm water (not to exceed 45°C/113°F) and dishwashing soap to remove remaining saliva and debris from the device.

  • Only use soft, antibacterial dish soap (liquid)
  • Do not use flavored or scented soaps
  • Do not use soaps with heavy dyes and colors
  • Rinse the device thoroughly with cool water.
  • Do not use hot water, as it can warp the device.
  • Do not use mouthwash, as it can discolor the device.
  • Clean the device daily.

USING CLEANING AGENTS

For periodic debris removal and maintenance, use a soft bristle brush to clean the inside of your appliance for debris removal. The product should be cleaned with antibacterial cleaning solutions like Polident and Efferdent. These cleaners are designed for use in brief sessions of 10–15 minutes. Always make sure to follow the manufacturer's instructions for proper use.

 

Do not use:

Avoid immersing the product in, or cleaning it with, any of the following substances: sodium hypochlorite (chlorine bleach), hydrogen peroxide, mouthwash, or alcohol products. Using these can lead to discoloration and damage to the material.

Storage instructions

The device should be stored in a dry, clean container when not in use.

Additional Information

  • Clinical studies have shown that the softening thermodynamics of the 3D-printed Nightguard effectively protects the teeth from damage caused by bruxism.
  • Patients should consult with your practice if they experience tooth pain or sensitivity, as this may be a sign
    of a more severe underlying issue.
  • Patients may experience mouth or tooth soreness when first using the device, which should resolve after a few days.
  • Softening thermodynamic nightguards have a limited warranty, which may vary depending on the manufacturer.

ADA Codes

Occlusal Guards
Night Guard - Occlusal Guard by Report D9940 Occlusal Guard by Report
Sports Guard - Fabrication of Athletic Mouthguard D9941 Fabrication of Athletic Mouthguard

Material Safety Data Sheets (MSDS)

Please see the attached night guard Material Safety Data Sheets for additional information.

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